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ATI-501 Oral Suspension Compared to Placebo in Subjects With Alopecia Areata, Alopecia Universalis or Alopecia Totalis

Sponsor
Aclaris Therapeutics, Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT03594227
Collaborator
(none)
87
Enrollment
25
Locations
4
Arms
12.2
Actual Duration (Months)
3.5
Patients Per Site
0.3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This Phase 2, multicenter, randomized study will evaluate the safety, tolerability and efficacy of ATI-501 for the treatment of Alopecia Areata (AA), Alopecia Universalis (AU) or Alopecia Totalis (AT) in adult subjects.

Condition or Disease Intervention/Treatment Phase
  • Drug: ATI-501 400mg BID (Low dose)
  • Drug: ATI-501 600mg BID (Mid dose)
  • Drug: ATI-501 800mg BID (High dose)
  • Drug: Placebo
 Phase 2

Detailed Description

This Phase 2, multicenter, randomized study will evaluate the safety, tolerability and efficacy of ATI-501 for the treatment of Alopecia Areata (AA), Alopecia Universalis (AU) or Alopecia Totalis (AT) in adult subjects. Subjects will be required to have a clinical diagnosis of stable AA, AU, or AT. A total of approximately 80 subjects will be randomized.

Study Design

Study Type:
Interventional
Actual Enrollment :
87 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Care Provider, Investigator)
Primary Purpose:
Other
Official Title:
A Randomized, Double-Blind, Placebo-Controlled Multicenter Study to Evaluate the Safety, Tolerability and Efficacy of ATI-501 Oral Suspension Compared to Placebo in Adult Subjects With Alopecia Areata, Alopecia Universalis or Alopecia Totalis
Actual Study Start Date :
Jun 11, 2018
Actual Primary Completion Date :
Jun 6, 2019
Actual Study Completion Date :
Jun 18, 2019

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: 400mg BID (Low dose)

ATI-501 low dose - oral administration

Drug: ATI-501 400mg BID (Low dose)
ATI-501 400mg BID oral low dose for oral administration
Other Names:
  • Active comparator: Low dose

    		•
    Active Comparator: 600mg BID (Mid dose)

    ATI-501 mid dose - oral administration

    Drug: ATI-501 600mg BID (Mid dose)
    ATI-501 600mg BID oral mid dose for oral administration
    Other Names:
  • Comparator : Mid dose

    		•
    Active Comparator: 800mg BID (High dose)

    ATI-501 high dose - oral administration

    Drug: ATI-501 800mg BID (High dose)
    ATI-501 800mg BID high dose for oral administration
    Other Names:
  • Comparator: high dose - oral administration

    		•
    Placebo Comparator: Placebo

    Placebo - oral administration

    Drug: Placebo
    Placebo - oral administration

    Outcome Measures

    Primary Outcome Measures

    1. Percent Change From Baseline in the Severity of Alopecia Tool (SALT) Score at Week 24 [Baseline-Week 24]

      The Severity of Alopecia Tool (SALT) score is a physician administered scale measuring the amount of scalp without any terminal hair assessed by the investigator. Possible scores range from 0 (no scalp hair loss) to 100 (complete scalp hair loss). A negative change in the SALT score over time represents hair regrowth by adding the percentage hair loss in the various areas (i.e. top, back, each side) of the scalp. The primary efficacy variable was the percent change from baseline in SALT score at Week 24. This was calculated as the mean of the changes from Baseline (Visit 2) SALT score to Week 24 (Visit 10) SALT score, divided by Baseline SALT score and expressed as a percentage.

    Secondary Outcome Measures

    1. Percent Change From Baseline in the Alopecia Density and Extent Score (ALODEX) at Week 24 [Baseline-Week 24]

      The Alopecia Density and Extent (ALODEX) score is a measurement of the amount of scalp with terminal hair loss assessed by the investigator at Baseline, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24. ALODEX breaks the scalp up into a grid of 1% scalp surface areas and assigns density rating in each area on a 10 point scale of hair loss (0= no hair loss to 10 = complete baldness). Summation of scores from each 1% scalp surface area provides an overall score which may range from 0 (no scalp hair loss) to 100 (complete baldness). A negative change in the ALODEX score over time represents hair regrowth.

    2. Mean Change From Baseline in the Severity of Alopecia Tool (SALT) Score at Week 24 [Baseline-Week 24]

      The Severity of Alopecia Tool (SALT) score is a physician administered scale measuring the amount of scalp without any terminal hair assessed by the investigator. Possible scores range from 0 (no scalp hair loss) to 100 (complete scalp hair loss). A negative change in the SALT score over time represents hair regrowth by adding the percentage hair loss in the various areas (i.e. top, back, each side) of the scalp.

    3. Mean Change From Baseline in the Alopecia Density and Extent (ALODEX) Score at Week 24 [Baseline-Week 24]

      The Alopecia Density and Extent (ALODEX) score is a measurement of the amount of scalp with terminal hair loss assessed by the investigator. ALODEX breaks the scalp up into a grid of 1% scalp surface areas and assigns density rating in each area on a 10 point scale of hair loss (0= no hair loss to 10 = complete baldness). Summation of scores from each 1% scalp surface area provides an overall score which may range from 0 (no scalp hair loss) to 100 (complete baldness). A negative change in the ALODEX score over time represents hair regrowth.

    4. Count of Subjects Achieving at Least a 50% Reduction in Alopecia Density and Extent (ALODEX) Score at Week 24 [Baseline-Week 24]

      The Alopecia Density and Extent (ALODEX) score is a measurement of the amount of scalp with terminal hair loss assessed by the investigator. ALODEX breaks the scalp up into a grid of 1% scalp surface areas and assigns density rating in each area on a 10 point scale of hair loss (0= no hair loss to 10 = complete baldness). Summation of scores from each 1% scalp surface area provides an overall score which may range from 0 (no scalp hair loss) to 100 (complete baldness). A negative change in the ALODEX score over time represents hair regrowth.

    5. Count of Subjects in Each Treatment Arm Achieving at Least a 50% Reduction in Severity of Alopecia Tool (SALT) Score at Week 24 Compared to Baseline [Baseline-Week 24]

      The Severity of Alopecia Tool (SALT) score is a physician administered scale measuring the amount of scalp without any terminal hair assessed by the investigator. Possible scores range from 0 (no scalp hair loss) to 100 (complete scalp hair loss). A negative change in the SALT score over time represents hair regrowth by adding the percentage hair loss in the various areas (i.e. top, back, each side) of the scalp.

    6. Change From Baseline in Alopecia Facial Hair Appearance Assessment (AFHA)-Clinician Reported Outcome, Left Eyebrow [Baseline-Week 24]

      The Alopecia Facial Hair Appearance Assessment (AFHA)-Clinician Reported Outcome is the investigator's assessment of the subject's facial hair (eyebrow(s), eyelashes,and if male, beard) at a particular point in time. The investigator was instructed to NOT refer to any other assessments to assist with these assessments. The investigator or designee assessed the affected facial hair areas (eyebrows, eyelashes and if male, beard) using a 5 point scale for each target area [1-Full (Target Area Hair); 2-Most (Target Area Hair); 3-Some (Target Area Hair); 4-A Little (Target Area Hair); 5-No (Target Area Hair)]. Change status is categorized as 'Better by x points' when the score decreases from baseline by x points, and as 'Worse by x points' when the score increases by x points.

    7. Change From Baseline in Alopecia Facial Hair Appearance Assessment (AFHA)-Clinician Reported Outcome, Right Eyebrow [Baseline-Week 24]

      The Alopecia Facial Hair Appearance Assessment (AFHA)-Clinician Reported Outcome is the investigator's assessment of the subject's facial hair (eyebrow(s), eyelashes,and if male, beard) at a particular point in time. The investigator was instructed to NOT refer to any other assessments to assist with these assessments. The investigator or designee assessed the affected facial hair areas (eyebrows, eyelashes and if male, beard) using a 5 point scale for each target area [1-Full (Target Area Hair); 2-Most (Target Area Hair); 3-Some (Target Area Hair); 4-A Little (Target Area Hair); 5-No (Target Area Hair)]. Change status is categorized as 'Better by x points' when the score decreases from baseline by x points, and as 'Worse by x points' when the score increases by x points.

    8. Change From Baseline in Alopecia Facial Hair Appearance Assessment (AFHA)-Clinician Reported Outcome, Left Eyelash [Baseline-Week 24]

      The Alopecia Facial Hair Appearance Assessment (AFHA)-Clinician Reported Outcome is the investigator's assessment of the subject's facial hair (eyebrow(s), eyelashes,and if male, beard) at a particular point in time. The investigator was instructed to NOT refer to any other assessments to assist with these assessments. The investigator or designee assessed the affected facial hair areas (eyebrows, eyelashes and if male, beard) using a 5 point scale for each target area [1-Full (Target Area Hair); 2-Most (Target Area Hair); 3-Some (Target Area Hair); 4-A Little (Target Area Hair); 5-No (Target Area Hair)]. Change status is categorized as 'Better by x points' when the score decreases from baseline by x points, and as 'Worse by x points' when the score increases by x points.

    9. Change From Baseline in Alopecia Facial Hair Appearance Assessment (AFHA)-Clinician Reported Outcome, Right Eyelash [Baseline-Week 24]

      The Alopecia Facial Hair Appearance Assessment (AFHA)-Clinician Reported Outcome is the investigator's assessment of the subject's facial hair (eyebrow(s), eyelashes,and if male, beard) at a particular point in time. The investigator was instructed to NOT refer to any other assessments to assist with these assessments. The investigator or designee assessed the affected facial hair areas (eyebrows, eyelashes and if male, beard) using a 5 point scale for each target area [1-Full (Target Area Hair); 2-Most (Target Area Hair); 3-Some (Target Area Hair); 4-A Little (Target Area Hair); 5-No (Target Area Hair)]. Change status is categorized as 'Better by x points' when the score decreases from baseline by x points, and as 'Worse by x points' when the score increases by x points.

    10. Change From Baseline in Alopecia Facial Hair Appearance Assessment (AFHA)-Clinician Reported Outcome, Beard, Male Subjects [Baseline-Week 24]

      The Alopecia Facial Hair Appearance Assessment (AFHA)-Clinician Reported Outcome is the investigator's assessment of the subject's facial hair (eyebrow(s), eyelashes,and if male, beard) at a particular point in time. The investigator was instructed to NOT refer to any other assessments to assist with these assessments. The investigator or designee assessed the affected facial hair areas (eyebrows, eyelashes and if male, beard) using a 5 point scale for each target area [1-Full (Target Area Hair); 2-Most (Target Area Hair); 3-Some (Target Area Hair); 4-A Little (Target Area Hair); 5-No (Target Area Hair)]. Change status is categorized as 'Better by x points' when the score decreases from baseline by x points, and as 'Worse by x points' when the score increases by x points.

    11. Change From Baseline in Alopecia Facial Hair Appearance Assessment (AFHA)-Patient Reported Outcome, Left Eyebrow [Baseline-Week 24]

      The Alopecia Facial Hair Appearance Assessment (AFHA)-Patient Reported Outcome is the patient's assessment of their facial hair (eyebrow(s), eyelashes, and if male, beard) at a particular point in time. The patient assessed the affected facial hair areas (eyebrows, eyelashes and if male, beard) using a 5 point scale for each target area [1-Full (Target Area Hair); 2-Most (Target Area Hair); 3-Some (Target Area Hair); 4-A Little (Target Area Hair); 5-No (Target Area Hair)]. Change status is categorized as 'Better by x points' when the score decreases from baseline by x points, and as 'Worse by x points' when the score increases by x points.

    12. Change From Baseline in Alopecia Facial Hair Appearance Assessment (AFHA)-Patient Reported Outcome, Right Eyebrow [Baseline-Week 24]

      The Alopecia Facial Hair Appearance Assessment (AFHA)-Patient Reported Outcome is the patient's assessment of their facial hair (eyebrow(s), eyelashes, and if male, beard) at a particular point in time. The patient assessed the affected facial hair areas (eyebrows, eyelashes and if male, beard) using a 5 point scale for each target area [1-Full (Target Area Hair); 2-Most (Target Area Hair); 3-Some (Target Area Hair); 4-A Little (Target Area Hair); 5-No (Target Area Hair)]. Change status is categorized as 'Better by x points' when the score decreases from baseline by x points, and as 'Worse by x points' when the score increases by x points.

    13. Change From Baseline in Alopecia Facial Hair Appearance Assessment (AFHA)-Patient Reported Outcome, Right Eyelash [Baseline-Week 24]

      The Alopecia Facial Hair Appearance Assessment (AFHA)-Patient Reported Outcome is the patient's assessment of their facial hair (eyebrow(s), eyelashes, and if male, beard) at a particular point in time. The patient assessed the affected facial hair areas (eyebrows, eyelashes and if male, beard) using a 5 point scale for each target area [1-Full (Target Area Hair); 2-Most (Target Area Hair); 3-Some (Target Area Hair); 4-A Little (Target Area Hair); 5-No (Target Area Hair)]. Change status is categorized as 'Better by x points' when the score decreases from baseline by x points, and as 'Worse by x points' when the score increases by x points.

    14. Change From Baseline in Alopecia Facial Hair Appearance Assessment (AFHA)-Patient Reported Outcome, Left Eyelash [Baseline-Week 24]

      The Alopecia Facial Hair Appearance Assessment (AFHA)-Patient Reported Outcome is the patient's assessment of their facial hair (eyebrow(s), eyelashes, and if male, beard) at a particular point in time. The patient assessed the affected facial hair areas (eyebrows, eyelashes and if male, beard) using a 5 point scale for each target area [1-Full (Target Area Hair); 2-Most (Target Area Hair); 3-Some (Target Area Hair); 4-A Little (Target Area Hair); 5-No (Target Area Hair)]. Change status is categorized as 'Better by x points' when the score decreases from baseline by x points, and as 'Worse by x points' when the score increases by x points.

    15. Change From Baseline in Alopecia Facial Hair Appearance Assessment (AFHA)-Patient Reported Outcome, Beard, Male Subjects [Baseline-Week 24]

      The Alopecia Facial Hair Appearance Assessment (AFHA)-Patient Reported Outcome is the patient's assessment of their facial hair (eyebrow(s), eyelashes, and if male, beard) at a particular point in time. The patient assessed the affected facial hair areas (eyebrows, eyelashes and if male, beard) using a 5 point scale for each target area [1-Full (Target Area Hair); 2-Most (Target Area Hair); 3-Some (Target Area Hair); 4-A Little (Target Area Hair); 5-No (Target Area Hair)]. Change status is categorized as 'Better by x points' when the score decreases from baseline by x points, and as 'Worse by x points' when the score increases by x points.

    16. Change From Baseline in the Subject Global Impression of Severity (SGIS) at Week 24, Patchy Alopecia Areata [Baseline-Week 24]

      The Subject Global Impression of Severity (SGIS) is a 5-point descriptive scale completed by subjects to capture the subject's assessment of disease severity at a particular timepoint. Scores of 1 to 5 are assigned to responses Mild to Extremely Severe, respectively. Change status is categorized as 'Better by x points' when the score decreases from baseline by x points, and as 'Worse by x points' when the score increases by x points.

    17. Change From Baseline in the Subject Global Impression of Severity (SGIS) at Week 24, Alopecia Universalis or Alopecia Totalis [Baseline-Week 24]

      The Subject Global Impression of Severity (SGIS) is a 5-point descriptive scale completed by subjects to capture the subject's assessment of disease severity at a particular timepoint. Scores of 1 to 5 are assigned to responses Mild to Extremely Severe, respectively. Change status is categorized as 'Better by x points' when the score decreases from baseline by x points, and as 'Worse by x points' when the score increases by x points.

    18. Change From Baseline in the Physician Global Impression of Severity (PhGIS) at Week 24, Patchy Alopecia Areata [Baseline-Week 24]

      The Physician Global Impression of Severity (PhGIS) is a 5-point descriptive scale completed by investigators and is used to capture the investigator's assessment of the subject's disease severity at a particular timepoint. Scores of 1 to 5 are assigned to responses Mild to Extremely Severe, respectively. Change status is categorized as 'Better by x points' when the score decreases from baseline by x points, and as 'Worse by x points' when the score increases by x points.

    19. Change From Baseline in the Physician Global Impression of Severity (PhGIS) at Week 24, Alopecia Universalis or Alopecia Totalis [Baseline-Week 24]

      The Physician Global Impression of Severity (PhGIS) is a 5-point descriptive scale completed by investigators and is used to capture the investigator's assessment of the subject's disease severity at a particular timepoint. Scores of 1 to 5 are assigned to responses Mild to Extremely Severe, respectively. Change status is categorized as 'Better by x points' when the score decreases from baseline by x points, and as 'Worse by x points' when the score increases by x points.

    20. Alopecia Impact Assessment (AIA) Patient Reported Outcome Change From Baseline at Week 24 [Baseline-Week 24]

      The Alopecia Impact Assessment (AIA) is a 13-item patient reported outcome questionnaire which measures the subject's experience with impacts related to alopecia (inclusive of all 3 subtypes observed on study) in managing appearance, worry, sadness, loss of confidence, self-consciousness, embarrassment, feeling unattractive, limitation of social activities, limitation of physical activities, unwanted attention, sweat in eyes, debris in eyes, and debris in nose. The AIA has a recall period of "over the past seven days". An 11-point NRS with anchors "0 - Not at all [impact]" and "10 - Extremely [impact]" (e.g., "Not at all bothersome" and "Extremely bothersome"; "Not at all worried" and "Extremely worried") is utilized. The AIA produces single-item (0-10) and mean total (0-10) scores, with higher scores indicating higher levels of impact.

    21. Subject Global Impression of Treatment Satisfaction (SGITS) at Week 24, Patchy Alopecia Areata [Baseline-Week 24]

      The Subject Global Impression of Treatment Satisfaction (SGITS) is a 7-point descriptive scale completed by subjects. Scale response options ranged from "1. Extremely Satisfied" to "7. Extremely Dissatisfied" and are used to capture how satisfied or dissatisfied they are with the study medication treatment received for their alopecia areata.

    22. Subject Global Impression of Treatment Satisfaction (SGITS) at Week 24, Alopecia Universalis or Alopecia Totalis [Baseline-Week 24]

      The Subject Global Impression of Treatment Satisfaction (SGITS) is a 7-point descriptive scale completed by subjects. Scale response options ranged from "1. Extremely Satisfied" to "7. Extremely Dissatisfied" and are used to capture how satisfied or dissatisfied they are with the study medication treatment received for their alopecia areata.

    23. Change From Baseline in the Subject Global Satisfaction With Hair Quality (SGSHQ) for Entire Scalp at Week 24, Patchy Alopecia Areata [Baseline-Week 24]

      The investigator or study staff instructed the subject to answer the Subject Global Satisfaction with Hair Quality (SGSHQ) questionnaire in relation to their satisfaction with the quality of scalp hair at the time of questionnaire completion (ie "right now"). Subjects assessed their satisfaction with the quality of their scalp hair on a 7-point satisfaction scale from extremely satisfied to extremely dissatisfied at the visits. Change status is categorized as 'Better by x points' when the score decreases from baseline by x points, and as 'Worse by x points' when the score increases by x points.

    24. Change From Baseline in the Subject Global Satisfaction With Hair Quality (SGSHQ) for Entire Scalp at Week 24, Alopecia Universalis or Alopecia Totalis [Baseline-Week 24]

      The investigator or study staff instructed the subject to answer the Subject Global Satisfaction with Hair Quality (SGSHQ) questionnaire in relation to their satisfaction with the quality of scalp hair at the time of questionnaire completion (ie "right now"). Subjects assessed their satisfaction with the quality of their scalp hair on a 7-point satisfaction scale from extremely satisfied to extremely dissatisfied at the visits. Change status is categorized as 'Better by x points' when the score decreases from baseline by x points, and as 'Worse by x points' when the score increases by x points.

    25. Change in Dermatology Life Quality Index Total Score (DLQI) Between Baseline and Week 24 [Baseline-Week 24]

      The 10 question Dermatology Life Quality Index (DLQI) questionnaire was completed by subjects at Baseline, Week 4, Week 12, and Week 24. When completing the questionnaire, subjects were instructed to think of their hair loss in place of "skin problem" and "skin" as referenced in the questionnaire. Possible summary scores could range from 0 to 30 with higher scores indicating a worse outcome.

    26. Subject Global Impression of Change (SGIC) at Week 24 [Baseline-Week 24]

      The Subject Global Impression of Change (SGIC) is a 7-point descriptive scale completed by subjects at Week 24 (Intent-to-treat population with reported data falling within the windowed Week 24 visit timeframe). Scale response options ranged from "1. Very much improved" to "7. Very much worse" and are used to capture the subject's overall impression of change for his/her alopecia during the treatment period.

    27. Physician Global Impression of Change (PhGIC) at Week 24 [Baseline-Week 24]

      The Physician Global Impression of Change (PhGIC) is a 7-point descriptive scale completed by investigators at Week 24 (Intent-to-treat population with reported data falling within the windowed Week 24 visit timeframe). Scale response options ranged from "1. Very much improved" to "7. Very much worse" and are used to capture the investigator's overall impression of change for the subject's alopecia during the treatment period.

    28. Change From Baseline in Alopecia Scalp Appearance Assessment (ASAA): Scalp-Clinician Reported Outcome for Target Patch, Patchy Alopecia Areata [Baseline-Week 24]

      The Scalp Clinician Reported Outcome for Target Patch provides the investigator's assessment for Patchy Alopecia Areata (AAP) patients regarding the appearance of the patient's target patch (identified by the patient as his or her most bothersome area of scalp hair loss at Baseline). The assessment was completed by investigators at Baseline, Week 2, Week 12, and Week 24. The assessment has a recall period of "right now" and includes a five-point VRS ranging from "Full hair, scalp of the target patch completely covered with hair" to "no hair, scalp of the target patch completely exposed." The instrument produces a score of 1 to 5, with lower scores indicating more hair covering the patient's target patch. Change status is categorized as 'Better by x points' when the score decreases from baseline by x points, and as 'Worse by x points' when the score increases by x points.

    29. Change From Baseline in Alopecia Scalp Appearance Assessment (ASAA): Scalp-Clinician Reported Outcome for Entire Scalp, All Patients [Baseline-Week 24]

      The Scalp Clinician Reported Outcome for Entire Scalp was completed for patients with Patchy Alopecia Areata, Alopecia Universalis, and Alopecia Totalis and assesses the appearance of the patient's whole scalp. The assessment was completed by investigators at Baseline, Week 2, Week 12, and Week 24. The assessment has a recall period of "right now" and includes a five-point VRS ranging from "Full hair, whole scalp completely covered with hair" to "no hair, whole scalp completely exposed." The instrument produces a score of 1 to 5, with lower scores indicating more hair covering the patient's whole scalp. Change status is categorized as 'Better by x points' when the score decreases from baseline by x points, and as 'Worse by x points' when the score increases by x points.

    30. Change From Baseline in Alopecia Scalp Appearance Assessment (ASAA): Scalp-Patient Reported Outcome for Target Patch, Patchy Alopecia Areata [Baseline-Week 24]

      The Scalp Patient Reported Outcome for Target Patch was completed by patients with Patchy Alopecia Areata (AAP) and assesses the appearance of the subject's target patch (identified by the subject as his or her most bothersome area of scalp hair loss at Baseline). The assessment was completed by AAP subjects at Baseline, Week 2, Week 12, and Week 24. The assessment has a recall period of "right now" and includes a five-point VRS ranging from "Full hair, scalp of the target patch completely covered with hair" to "no hair, scalp of the target patch completely exposed." The instrument produces a score of 1 to 5, with lower scores indicating more hair covering the subject's target patch. Change status is categorized as 'Better by x points' when the score decreases from baseline by x points, and as 'Worse by x points' when the score increases by x points.

    31. Change From Baseline in Alopecia Scalp Appearance Assessment (ASAA): Scalp-Patient Reported Outcome for Entire Scalp, All Patients [Baseline-Week 24]

      The Scalp Patient Reported Outcome for Entire Scalp was completed by patients with Patchy Alopecia Areata, Alopecia Universalis, and Alopecia Totalis and assesses the appearance of the patient's whole scalp. The assessment was completed by patients at Baseline, Week 2, Week 12, and Week 24. The assessment has a recall period of "right now" and includes a five-point VRS ranging from "Full hair, whole scalp completely covered with hair" to "no hair, whole scalp completely exposed." The instrument produces a score of 1 to 5, with lower scores indicating more hair covering the patient's target patch. Change status is categorized as 'Better by x points' when the score decreases from baseline by x points, and as 'Worse by x points' when the score increases by x points.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:
    Subjects must meet the following criteria to be eligible for participation in the study:

    1. Able to comprehend and willing to sign an Informed Consent Form (ICF).

    2. Male or non-pregnant, non-nursing female ≥ 18 years old at the time of informed consent.

    3. Have a clinical diagnosis of stable Alopecia Areata (AA), Alopecia Universalis (AU), or Alopecia Totalis (AT).

    4. If the subject is a woman of childbearing potential (WOCBP), she must have:

    • Negative urine and serum pregnancy tests at Screening (Visit 1); and

    • A negative urine pregnancy test at Baseline (Visit 2); and

    • Agree to not be planning a pregnancy during the study duration and use a highly effective method of contraception for the duration of the study and 30 days after the last dose of study medication. (Refer to Section 8.4.2).

    1. Be in good general health and free of any known disease state or physical condition which, in the investigator's opinion, might impair evaluation of the subject or which might expose the subject to an unacceptable risk by study participation.

    2. Be willing to maintain the same hair style and hair dyeing throughout the study period.

    3. Subjects taking hormonal replacement therapies must be on stable doses for 6 months prior to enrollment and remain on a maintenance dose throughout the study.

    4. Subjects taking thyroid replacement medication must be on stable doses for 6 months prior to enrollment and remain on a maintenance dose throughout the study.

    5. Sexually active male subjects whose partner is a WOCBP must agree to use a barrier method of contraception from the first dose of study medication to at least 30 days after the last dose of study medication.

    Exclusion Criteria:
    Subjects are excluded from this study if any 1 or more of the following criteria is met:

    1. Females who are nursing, pregnant, or planning to become pregnant for the duration of the study and up to 30 days after the last dose of study medication.

    2. Diffuse AA or a history of an atypical pattern of AA.

    3. Concomitant hair loss disorder (by history or physical exam) such as androgenetic alopecia (AGA) or scarring alopecia.

    4. Active skin disease on the scalp or a history of skin disease on the scalp that in the opinion of the investigator would interfere with study assessments of efficacy or safety.

    5. Active scalp trauma or other condition affecting the scalp that, in the investigator's opinion, may affect the course of AA, AU or AT or interfere with the study conduct or evaluations.

    6. The presence of a permanent or difficult to remove hairpiece or wig that will, in the opinion of the investigator, interfere with study assessments if not removed at each visit.

    7. History of, or current, severe, progressive or uncontrolled autoimmune, metabolic, hepatic, endocrine, renal, gastrointestinal, pulmonary, cardiovascular, genitourinary, or hematological disease, neurologic or cerebral disorders, or coagulation disorders that, as determined by the Investigator, would preclude participation in and completion of study assessments.

    8. History of, current or suspected systemic or cutaneous malignancy and /or lymphoproliferative disease, other than subjects with a history of adequately treated and well healed and completely cleared non-melanoma skin cancers (e.g. basal or squamous cell carcinoma) treated successfully at least 1 year prior to study entry with no evidence of disease.

    9. Evidence of active or latent bacterial (including tuberculosis) or viral infections at the time of enrollment, or history of incompletely treated or untreated tuberculosis. Subjects who have completed therapy for latent tuberculosis may participate.

    10. History of serious local infection (e.g., cellulitis, abscess) or systemic infection including but not limited to a history of treated infection (e.g., pneumonia, septicemia) within 3 months prior to Baseline. Subjects on an antibiotic for a nonserious, acute local infection must complete the course prior to enrollment into the study.

    11. Positive for HIV, Hepatitis B or C. Subjects with serologic evidence of Hepatitis B vaccination (HepB surface Ab without the presence of Hep B surface Ag will be allowed to participate).

    12. History of recurrent herpes zoster (more than one episode) or disseminated herpes zoster (a single episode) or disseminated herpes simplex (single episode) or cytomegalovirus (CMV) that resolved less than 2 months before study enrollment. Subjects with a history of frequent outbreaks of Herpes Simplex Virus (defined as 4 or more outbreaks a year).

    13. Subjects who have received any of the following treatments for the timeframes specified below:

    • Disease Modifying Anti-Rheumatic Drugs (DMARDS), Biologics or immunosuppressants, including but not limited to: anakinra, adalimumab, azathioprine, corticosteroids, cyclosporine, etanercept, infliximab, methotrexate, TNF inhibitors, ustekinumab within 1 month or 5 half-lives (whichever is greater) of Baseline (Visit 2).

    • Plaquenil within 2 months of Baseline (Visit 2).

    • Janus kinase (JAK) inhibitors (oral or topical) within 6 months of Baseline (Visit 2).

    • Intralesional steroids or platelet rich plasma injections in the scalp within 1 month of Baseline (Visit 2).

    • Topical treatments on the scalp with anthralin, bimatoprost, corticosteroids, diphencyprone, diphenylcyclopropenone (DPCP), squaric acid dibutylester (SADBE), minoxidil, pimecrolimus, or tacrolimus within 1 month of Baseline (Visit 2).

    • Phototherapy (narrow band Ultraviolet B [NB UVB] or broadband therapy) within 4 weeks of Baseline (Visit 2).

    1. Participation in an investigational drug or device trial in which administration of an investigational drug or device occurred within 30 days or 5 half-lives (whichever is longer) of Baseline (Visit 2).

    2. Any condition possibly affecting oral drug absorption, e.g., gastrectomy, clinically significant diabetic gastroenteropathy, or certain types of bariatric surgery such as gastric bypass. Procedures such as gastric banding are not exclusionary.

    3. Unwillingness to refrain from weaves, hair extensions, or shaving of the scalp for at least two weeks prior to a study visit, at the discretion of the investigator, based on the ability to assess hair growth.

    4. Vaccination with a live or attenuated vaccine within 6 weeks prior to Baseline (Visit

    1. or planned vaccination with these vaccines at any time during treatment or within 6 weeks following discontinuation of study medication.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Aclaris Investigator Site Hot Springs Arkansas United States 71913
    2 Aclaris Investigator Site Rogers Arkansas United States 72758
    3 Aclaris Investigator Site Denver Colorado United States 80210
    4 Aclaris Investigator Site Boynton Beach Florida United States 33472
    5 Aclaris Investigator Site Miami Florida United States 33137
    6 Aclaris Investigator Site Sanford Florida United States 32771
    7 Aclaris Investigator Site Snellville Georgia United States 30078
    8 Aclaris Investigator Site Clinton Township Michigan United States 48038
    9 Aclaris Investigator Site Detroit Michigan United States 48202
    10 Aclaris Investigator Site Fridley Minnesota United States 55432
    11 Aclaris Investigator Site Minneapolis Minnesota United States 55455
    12 Aclaris Investigator Site Saint Joseph Missouri United States 64506
    13 Aclaris Investigator Site Omaha Nebraska United States 68144
    14 Aclaris Investigator Site Las Vegas Nevada United States 89148
    15 Aclaris Investigator Site New York New York United States 10075
    16 Aclaris Investigator Site Rochester New York United States 14623
    17 Aclaris Investigator Site Portland Oregon United States 97223
    18 Aclaris Investigator Site Greenville South Carolina United States 29607
    19 Aclaris Investigator Site Knoxville Tennessee United States 37922
    20 Aclaris Investigator Site Nashville Tennessee United States 37215
    21 Aclaris Investigational Site Austin Texas United States 78745
    22 Aclaris Investigator Site Houston Texas United States 77056
    23 Aclaris Investigator Site San Antonio Texas United States 78213
    24 Aclaris Investigator Site Lynchburg Virginia United States 24501
    25 Aclaris Investigator Site Norfolk Virginia United States 23502

    Sponsors and Collaborators

    • Aclaris Therapeutics, Inc.

    Investigators

    • Study Chair: Susan Moran, RN, Aclaris Therapeutics

    Study Documents (Full-Text)

    More Information

    Publications

    None provided.
    Responsible Party:
    Aclaris Therapeutics, Inc.
    ClinicalTrials.gov Identifier:
    NCT03594227
    Other Study ID Numbers:
    • ATI-501-AUAT-201
    First Posted:
    Jul 20, 2018
    Last Update Posted:
    Sep 16, 2020
    Last Verified:
    Jun 1, 2020
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Alopecia
    Alopecia Areata

    Study Results

    Participant Flow

    Recruitment Details
    Pre-assignment Detail
    Arm/Group Title ATI-501 400mg BID Dosing ATI-501 600mg BID Dosing ATI-501 800mg BID Dosing Placebo
    Arm/Group Description ATI-501 400mg BID dosing - oral administration ATI-501 400mg BID dosing: ATI-501 oral low dose ATI-501 600mg BID dosing - oral administration ATI-501 600mg BID dosing: ATI-501 oral low dose ATI-501 800mg BID dosing - oral administration ATI-501 800mg BID dosing: ATI-501 high dose for oral administration Placebo: BID - oral administration
    Period Title: Overall Study
    STARTED 23 23 22 19
    COMPLETED 18 19 19 14
    NOT COMPLETED 5 4 3 5

    Baseline Characteristics

    Arm/Group Title ATI-501 400mg BID Dosing ATI-501 600mg BID Dosing ATI-501 800mg BID Dosing Placebo Total
    Arm/Group Description ATI-501 400mg BID dosing - oral administration ATI-501 400mg BID dosing: ATI-501 oral low dose ATI-501 600mg BID dosing - oral administration ATI-501 600mg BID dosing: ATI-501 oral low dose ATI-501 800mg BID dosing - oral administration ATI-501 800mg BID dosing: ATI-501 high dose for oral administration Placebo: BID - oral administration Total of all reporting groups
    Overall Participants 23 23 22 19 87
    Age (Count of Participants)
    <=18 years
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Between 18 and 65 years
    22
    95.7%
    21
    91.3%
    22
    100%
    16
    84.2%
    81
    93.1%
    >=65 years
    1
    4.3%
    2
    8.7%
    0
    0%
    3
    15.8%
    6
    6.9%
    Age (years) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [years]
    38.7
    (12.99)
    40.4
    (13.56)
    40.5
    (12.44)
    41.8
    (16.01)
    40.3
    (13.52)
    Sex: Female, Male (Count of Participants)
    Female
    17
    73.9%
    12
    52.2%
    13
    59.1%
    14
    73.7%
    56
    64.4%
    Male
    6
    26.1%
    11
    47.8%
    9
    40.9%
    5
    26.3%
    31
    35.6%
    Ethnicity (NIH/OMB) (Count of Participants)
    Hispanic or Latino
    7
    30.4%
    3
    13%
    2
    9.1%
    3
    15.8%
    15
    17.2%
    Not Hispanic or Latino
    10
    43.5%
    15
    65.2%
    13
    59.1%
    12
    63.2%
    50
    57.5%
    Unknown or Not Reported
    0
    0%
    1
    4.3%
    1
    4.5%
    0
    0%
    2
    2.3%
    Race (NIH/OMB) (Count of Participants)
    American Indian or Alaska Native
    0
    0%
    1
    4.3%
    0
    0%
    0
    0%
    1
    1.1%
    Asian
    0
    0%
    0
    0%
    1
    4.5%
    1
    5.3%
    2
    2.3%
    Native Hawaiian or Other Pacific Islander
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Black or African American
    6
    26.1%
    3
    13%
    5
    22.7%
    3
    15.8%
    17
    19.5%
    White
    17
    73.9%
    19
    82.6%
    16
    72.7%
    15
    78.9%
    67
    77%
    More than one race
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Unknown or Not Reported
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Fitzpatrick Skin Type (Count of Participants)
    I - Always Burns
    0
    0%
    0
    0%
    2
    9.1%
    0
    0%
    2
    2.3%
    II - Burns Easily
    5
    21.7%
    7
    30.4%
    6
    27.3%
    8
    42.1%
    26
    29.9%
    III - Burns Moderately
    7
    30.4%
    9
    39.1%
    4
    18.2%
    8
    42.1%
    28
    32.2%
    IV - Burns Minimally
    6
    26.1%
    3
    13%
    4
    18.2%
    0
    0%
    13
    14.9%
    V - Rarely Burns
    3
    13%
    4
    17.4%
    4
    18.2%
    3
    15.8%
    14
    16.1%
    VI - Never Burns
    2
    8.7%
    0
    0%
    2
    9.1%
    0
    0%
    4
    4.6%
    Hair Pull Test - Dislodged Hairs (Count of Participants)
    Normal (≤2 hairs dislodged)
    11
    47.8%
    9
    39.1%
    7
    31.8%
    6
    31.6%
    33
    37.9%
    Abnormal (>2 hairs dislodged)
    0
    0%
    5
    21.7%
    1
    4.5%
    1
    5.3%
    7
    8%
    N/A for subjects with AU and AT (>95% hair loss)
    12
    52.2%
    9
    39.1%
    13
    59.1%
    11
    57.9%
    45
    51.7%
    Hair pull test - broken hairs (Count of Participants)
    No
    11
    47.8%
    12
    52.2%
    6
    27.3%
    6
    31.6%
    35
    40.2%
    Yes
    0
    0%
    2
    8.7%
    2
    9.1%
    1
    5.3%
    5
    5.7%
    N/A for subjects with AU and AT (>95% hair loss)
    12
    52.2%
    9
    39.1%
    13
    59.1%
    11
    57.9%
    45
    51.7%
    Hair Pull Test - Broken at Borders (Count of Participants)
    No
    11
    47.8%
    12
    52.2%
    6
    27.3%
    6
    31.6%
    35
    40.2%
    Yes
    0
    0%
    2
    8.7%
    2
    9.1%
    1
    5.3%
    5
    5.7%
    N/A for subjects with AU and AT (>95% hair loss)
    12
    52.2%
    9
    39.1%
    13
    59.1%
    11
    57.9%
    45
    51.7%
    Vellus Hair Present (Count of Participants)
    No
    20
    87%
    18
    78.3%
    18
    81.8%
    15
    78.9%
    71
    81.6%
    Yes
    3
    13%
    4
    17.4%
    4
    18.2%
    4
    21.1%
    15
    17.2%
    Indeterminate hair present (Count of Participants)
    No
    21
    91.3%
    19
    82.6%
    19
    86.4%
    16
    84.2%
    75
    86.2%
    Yes
    2
    8.7%
    3
    13%
    3
    13.6%
    3
    15.8%
    11
    12.6%
    Baseline Severity of Alopecia Tool (SALT) Score Mean (score on a scale) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [score on a scale]
    78
    (26.7)
    76
    (23.4)
    81
    (25.8)
    85
    (24.8)
    80
    (25.0)
    Baseline Severity of Alopecia Tool (SALT) Scores Percentiles (Count of Participants)
    <50%
    5
    21.7%
    2
    8.7%
    5
    22.7%
    3
    15.8%
    15
    17.2%
    ≥50%
    18
    78.3%
    21
    91.3%
    17
    77.3%
    16
    84.2%
    72
    82.8%
    Baseline scalp-Patient-Reported Outcome for target patch, Alopecia Areata Patchy (AAP) subjects only (Count of Participants)
    Some hair
    0
    0%
    0
    0%
    0
    0%
    1
    5.3%
    1
    1.1%
    A little hair
    8
    34.8%
    8
    34.8%
    5
    22.7%
    4
    21.1%
    25
    28.7%
    No hair
    3
    13%
    6
    26.1%
    4
    18.2%
    3
    15.8%
    16
    18.4%
    N/A for subjects with AU and AT (>95% hair loss)
    12
    52.2%
    9
    39.1%
    13
    59.1%
    11
    57.9%
    45
    51.7%
    Baseline Scalp-Patient-Reported Outcome (PRO) for Entire Scalp (Count of Participants)
    Most hair
    1
    4.3%
    1
    4.3%
    2
    9.1%
    0
    0%
    4
    4.6%
    Some hair
    5
    21.7%
    6
    26.1%
    4
    18.2%
    3
    15.8%
    18
    20.7%
    A little hair
    6
    26.1%
    7
    30.4%
    6
    27.3%
    8
    42.1%
    27
    31%
    No hair
    11
    47.8%
    9
    39.1%
    10
    45.5%
    8
    42.1%
    38
    43.7%
    Baseline Scalp-Clinician Reported Outcomes (ClinRO) for Target Patch, AAP subjects only (Count of Participants)
    A little hair
    6
    26.1%
    7
    30.4%
    5
    22.7%
    5
    26.3%
    23
    26.4%
    No hair
    5
    21.7%
    7
    30.4%
    4
    18.2%
    3
    15.8%
    19
    21.8%
    N/A for subjects with AU and AT (>95% hair loss)
    12
    52.2%
    9
    39.1%
    13
    59.1%
    11
    57.9%
    45
    51.7%
    Baseline scalp-ClinRO for entire scalp (Count of Participants)
    Some hair
    8
    34.8%
    8
    34.8%
    6
    27.3%
    2
    10.5%
    24
    27.6%
    A little hair
    4
    17.4%
    7
    30.4%
    7
    31.8%
    9
    47.4%
    27
    31%
    No hair
    11
    47.8%
    8
    34.8%
    9
    40.9%
    8
    42.1%
    36
    41.4%
    Previous Therapies for Alopecia (Count of Participants)
    Subjects using prior therapy for alopecia
    21
    91.3%
    18
    78.3%
    21
    95.5%
    16
    84.2%
    76
    87.4%
    Topical immunotherapy
    8
    34.8%
    3
    13%
    5
    22.7%
    3
    15.8%
    19
    21.8%
    Corticosteroids
    16
    69.6%
    13
    56.5%
    15
    68.2%
    10
    52.6%
    54
    62.1%
    Systemic steroids
    11
    47.8%
    11
    47.8%
    5
    22.7%
    7
    36.8%
    34
    39.1%
    DMARDS
    0
    0%
    1
    4.3%
    1
    4.5%
    0
    0%
    2
    2.3%
    Biologics or immunosuppressants
    0
    0%
    1
    4.3%
    0
    0%
    1
    5.3%
    2
    2.3%
    Plaquenil
    1
    4.3%
    0
    0%
    0
    0%
    1
    5.3%
    2
    2.3%
    Phototherapy
    1
    4.3%
    0
    0%
    0
    0%
    0
    0%
    1
    1.1%
    Laser therapy
    1
    4.3%
    0
    0%
    0
    0%
    1
    5.3%
    2
    2.3%
    NB UVB
    0
    0%
    1
    4.3%
    0
    0%
    0
    0%
    1
    1.1%
    Other
    3
    13%
    2
    8.7%
    6
    27.3%
    3
    15.8%
    14
    16.1%
    Diagnosis Type (Count of Participants)
    Alopecia Areata
    11
    47.8%
    14
    60.9%
    9
    40.9%
    9
    47.4%
    43
    49.4%
    Alopecia Universalis
    4
    17.4%
    5
    21.7%
    7
    31.8%
    5
    26.3%
    21
    24.1%
    Alopecia Totalis
    8
    34.8%
    4
    17.4%
    6
    27.3%
    5
    26.3%
    23
    26.4%
    Ophiasis pattern of hair loss (Count of Participants)
    No ophiasis pattern
    19
    82.6%
    19
    82.6%
    18
    81.8%
    17
    89.5%
    73
    83.9%
    Ophiasis and Alopecia Areata
    4
    17.4%
    4
    17.4%
    4
    18.2%
    1
    5.3%
    13
    14.9%
    Duration of alopecia (years) (years) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [years]
    13.7
    (11.01)
    9.5
    (9.78)
    10.7
    (11.36)
    11.3
    (12.04)
    11.3
    (10.94)
    Duration of current episode of alopecia (weeks) (weeks) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [weeks]
    224.2
    (184.63)
    189.5
    (148.31)
    176.3
    (162.50)
    253.2
    (153.59)
    209.3
    (163.10)

    Outcome Measures

    1. Primary Outcome
    Title Percent Change From Baseline in the Severity of Alopecia Tool (SALT) Score at Week 24
    Description The Severity of Alopecia Tool (SALT) score is a physician administered scale measuring the amount of scalp without any terminal hair assessed by the investigator. Possible scores range from 0 (no scalp hair loss) to 100 (complete scalp hair loss). A negative change in the SALT score over time represents hair regrowth by adding the percentage hair loss in the various areas (i.e. top, back, each side) of the scalp. The primary efficacy variable was the percent change from baseline in SALT score at Week 24. This was calculated as the mean of the changes from Baseline (Visit 2) SALT score to Week 24 (Visit 10) SALT score, divided by Baseline SALT score and expressed as a percentage.
    Time Frame Baseline-Week 24

    Outcome Measure Data

    Analysis Population Description
    This primary analysis utilized the SALT score with imputation for last observation carried forward (LOCF) and was based on the intent-to-treat population.
    Arm/Group Title ATI-501 400mg BID Dosing ATI-501 600mg BID Dosing ATI-501 800mg BID Dosing Placebo
    Arm/Group Description ATI-501 400mg BID dosing (low dose) - oral administration ATI-501 Low dose: ATI-501 oral low dose ATI-501 600mg BID dosing (mid dose) - oral administration ATI-501 Mid dose ATI-501 800mg BID dosing (high dose) - oral administration ATI-501 high dose for oral administration Placebo - oral administration
    Measure Participants 23 23 22 19
    Mean (Standard Deviation) [percent]
    -25.6
    (39.75)
    -30.4
    (41.23)
    -25.9
    (29.86)
    -6.3
    (23.36)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection ATI-501 400mg BID Dosing, Placebo
    Comments The planned sample size is approximately 95 enrolled subjects with approximately 45 subjects enrolled with AT or AU. Because the primary efficacy analysis of mean percent reduction in hair loss using SALT scores is expected to be more sensitive than the SALT50 responder analysis, the power for the primary analysis is also expected to be no less than 80%.
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.011
    Comments All statistical testing was two-sided and performed using a significance (alpha) level of 0.05.
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Net)
    Estimated Value -19.26
    Confidence Interval (2-Sided) 95%
    -33.98 to -4.54
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 5.020
    Estimation Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection ATI-501 600mg BID Dosing, Placebo
    Comments The planned sample size is approximately 95 enrolled subjects with approximately 45 subjects enrolled with AT or AU. Because the primary efficacy analysis of mean percent reduction in hair loss using SALT scores is expected to be more sensitive than the SALT50 responder analysis, the power for the primary analysis is also expected to be no less than 80%.
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.001
    Comments All statistical testing was two-sided and performed using a significance (alpha) level of 0.05.
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value -24.08
    Confidence Interval (2-Sided) 95%
    -38.80 to -9.36
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 5.020
    Estimation Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection ATI-501 800mg BID Dosing, Placebo
    Comments The planned sample size is approximately 95 enrolled subjects with approximately 45 subjects enrolled with AT or AU. Because the primary efficacy analysis of mean percent reduction in hair loss using SALT scores is expected to be more sensitive than the SALT50 responder analysis, the power for the primary analysis is also expected to be no less than 80%.
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.010
    Comments All statistical testing was two-sided and performed using a significance (alpha) level of 0.05.
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value -19.54
    Confidence Interval (2-Sided) 95%
    -34.41 to -4.67
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 5.133
    Estimation Comments
    2. Secondary Outcome
    Title Percent Change From Baseline in the Alopecia Density and Extent Score (ALODEX) at Week 24
    Description The Alopecia Density and Extent (ALODEX) score is a measurement of the amount of scalp with terminal hair loss assessed by the investigator at Baseline, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24. ALODEX breaks the scalp up into a grid of 1% scalp surface areas and assigns density rating in each area on a 10 point scale of hair loss (0= no hair loss to 10 = complete baldness). Summation of scores from each 1% scalp surface area provides an overall score which may range from 0 (no scalp hair loss) to 100 (complete baldness). A negative change in the ALODEX score over time represents hair regrowth.
    Time Frame Baseline-Week 24

    Outcome Measure Data

    Analysis Population Description
    Intent-to-treat population using LOCF to address missing data.
    Arm/Group Title ATI-501 400mg BID Dosing ATI-501 600mg BID Dosing ATI-501 800mg BID Dosing Placebo
    Arm/Group Description ATI-501 400mg BID Dosing (low dose) - oral administration ATI-501 Low dose: ATI-501 oral low dose ATI-501 600mg BID Dosing (mid dose) - oral administration ATI-501 Mid dose ATI-501 800mg BID Dosing (high dose) - oral administration ATI-501 high dose Placebo - oral administration
    Measure Participants 23 23 22 19
    Least Squares Mean (Standard Error) [percent]
    -26.88
    (5.165)
    -32.24
    (5.165)
    -26.87
    (5.281)
    -7.70
    (5.683)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection ATI-501 400mg BID Dosing, Placebo
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.013
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value -19.17
    Confidence Interval (2-Sided) 95%
    -34.33 to -4.02
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 5.165
    Estimation Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection ATI-501 600mg BID Dosing, Placebo
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.002
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Net)
    Estimated Value -24.53
    Confidence Interval (2-Sided) 95%
    -39.69 to -9.38
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 5.165
    Estimation Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection ATI-501 800mg BID Dosing, Placebo
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.014
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Net)
    Estimated Value -19.17
    Confidence Interval (2-Sided) 95%
    -34.48 to -3.86
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 5.281
    Estimation Comments
    3. Secondary Outcome
    Title Mean Change From Baseline in the Severity of Alopecia Tool (SALT) Score at Week 24
    Description The Severity of Alopecia Tool (SALT) score is a physician administered scale measuring the amount of scalp without any terminal hair assessed by the investigator. Possible scores range from 0 (no scalp hair loss) to 100 (complete scalp hair loss). A negative change in the SALT score over time represents hair regrowth by adding the percentage hair loss in the various areas (i.e. top, back, each side) of the scalp.
    Time Frame Baseline-Week 24

    Outcome Measure Data

    Analysis Population Description
    Intent-to-treat population using Last Observation Carried Forward to address missing data.
    Arm/Group Title ATI-501 400mg BID ATI-501 600mg BID ATI-501 800mg BID Placebo
    Arm/Group Description ATI-501 400mg BID Dosing (low dose) - oral administration ATI-501 Low dose ATI-501 600mg BID (mid dose) - oral administration ATI-501 Mid dose ATI-501 800mg BID (high dose) - oral administration ATI-501 high dose Placebo - oral administration
    Measure Participants 23 23 22 19
    Mean (Standard Deviation) [score on a scale]
    -14.6
    (23.67)
    -18.6
    (27.29)
    -20.9
    (26.50)
    -3.3
    (8.21)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection ATI-501 400mg BID Dosing, Placebo
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.025
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Net)
    Estimated Value -11.29
    Confidence Interval (2-Sided) 95%
    -21.14 to -1.45
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 3.359
    Estimation Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection ATI-501 600mg BID Dosing, Placebo
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.003
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Net)
    Estimated Value -15.25
    Confidence Interval (2-Sided) 95%
    -25.10 to -5.40
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 3.359
    Estimation Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection ATI-501 800mg BID Dosing, Placebo
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Net)
    Estimated Value -17.55
    Confidence Interval (2-Sided) 95%
    -27.49 to -7.60
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 3.434
    Estimation Comments
    4. Secondary Outcome
    Title Mean Change From Baseline in the Alopecia Density and Extent (ALODEX) Score at Week 24
    Description The Alopecia Density and Extent (ALODEX) score is a measurement of the amount of scalp with terminal hair loss assessed by the investigator. ALODEX breaks the scalp up into a grid of 1% scalp surface areas and assigns density rating in each area on a 10 point scale of hair loss (0= no hair loss to 10 = complete baldness). Summation of scores from each 1% scalp surface area provides an overall score which may range from 0 (no scalp hair loss) to 100 (complete baldness). A negative change in the ALODEX score over time represents hair regrowth.
    Time Frame Baseline-Week 24

    Outcome Measure Data

    Analysis Population Description
    Intent-to-treat population using Last Observation Carried Forward to address missing data.
    Arm/Group Title ATI-501 400mg BID ATI-501 600mg BID ATI-501 800mg BID Placebo
    Arm/Group Description ATI-501 400mg BID (low dose) - oral administration ATI-501 Low dose ATI-501 600mg BID (mid dose) - oral administration ATI-501 Mid dose ATI-501 800mg BID (high dose) - oral administration ATI-501 high dose Placebo - oral administration
    Measure Participants 23 23 22 19
    Mean (Standard Deviation) [score on a scale]
    -17.6
    (26.93)
    -22.2
    (28.99)
    -20.7
    (25.04)
    -3.2
    (8.42)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection ATI-501 400mg BID Dosing, Placebo
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.008
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Net)
    Estimated Value -14.40
    Confidence Interval (2-Sided) 95%
    -24.95 to -3.84
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 3.599
    Estimation Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection ATI-501 600mg BID Dosing, Placebo
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Net)
    Estimated Value -19.01
    Confidence Interval (2-Sided) 95%
    -29.56 to -8.45
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 3.599
    Estimation Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection ATI-501 800mg BID Dosing, Placebo
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.001
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Net)
    Estimated Value -17.52
    Confidence Interval (2-Sided) 95%
    -28.18 to -6.86
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 3.679
    Estimation Comments
    5. Secondary Outcome
    Title Count of Subjects Achieving at Least a 50% Reduction in Alopecia Density and Extent (ALODEX) Score at Week 24
    Description The Alopecia Density and Extent (ALODEX) score is a measurement of the amount of scalp with terminal hair loss assessed by the investigator. ALODEX breaks the scalp up into a grid of 1% scalp surface areas and assigns density rating in each area on a 10 point scale of hair loss (0= no hair loss to 10 = complete baldness). Summation of scores from each 1% scalp surface area provides an overall score which may range from 0 (no scalp hair loss) to 100 (complete baldness). A negative change in the ALODEX score over time represents hair regrowth.
    Time Frame Baseline-Week 24

    Outcome Measure Data

    Analysis Population Description
    Intent-to-treat population using Last Observation Carried Forward to address missing data.
    Arm/Group Title ATI-501 400mg BID ATI-501 600mg BID ATI-501 800mg BID Placebo
    Arm/Group Description ATI-501 400mg BID (low dose) - oral administration ATI-501 Low dose ATI-501 600mg BID (mid dose) - oral administration ATI-501 Mid dose ATI-501 800mg BID (high dose) - oral administration ATI-501 high dose Vehicle - oral administration
    Measure Participants 23 23 22 19
    Count of Participants [Participants]
    6
    26.1%
    7
    30.4%
    5
    22.7%
    1
    5.3%
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection ATI-501 400mg BID Dosing, Placebo
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.124
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 4.6
    Confidence Interval (2-Sided) 95%
    0.7 to 31.8
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection ATI-501 600mg BID Dosing, Placebo
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.079
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 5.6
    Confidence Interval (2-Sided) 95%
    0.8 to 38.3
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection ATI-501 800mg BID Dosing, Placebo
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.177
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 3.9
    Confidence Interval (2-Sided) 95%
    0.5 to 27.7
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    6. Secondary Outcome
    Title Count of Subjects in Each Treatment Arm Achieving at Least a 50% Reduction in Severity of Alopecia Tool (SALT) Score at Week 24 Compared to Baseline
    Description The Severity of Alopecia Tool (SALT) score is a physician administered scale measuring the amount of scalp without any terminal hair assessed by the investigator. Possible scores range from 0 (no scalp hair loss) to 100 (complete scalp hair loss). A negative change in the SALT score over time represents hair regrowth by adding the percentage hair loss in the various areas (i.e. top, back, each side) of the scalp.
    Time Frame Baseline-Week 24

    Outcome Measure Data

    Analysis Population Description
    Intent-to-treat population using Last Observation Carried Forward to address missing data.
    Arm/Group Title ATI-501 400mg BID ATI-501 600mg BID ATI-501 800mg BID Placebo
    Arm/Group Description ATI-501 400mg BID (low dose) - oral administration ATI-501 Low dose ATI-501 600mg BID (mid dose) - oral administration ATI-501 Mid dose ATI-501 800mg BID (high dose) - oral administration ATI-501 high dose Placebo - oral administration
    Measure Participants 23 23 22 19
    Count of Participants [Participants]
    6
    26.1%
    7
    30.4%
    5
    22.7%
    1
    5.3%
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection ATI-501 400mg BID Dosing, Placebo
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.124
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 4.6
    Confidence Interval (2-Sided) 95%
    0.7 to 31.8
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection ATI-501 600mg BID Dosing, Placebo
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.079
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 5.6
    Confidence Interval (2-Sided) 95%
    0.8 to 38.3
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection ATI-501 800mg BID Dosing, Placebo
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.177
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 3.9
    Confidence Interval (2-Sided) 95%
    0.5 to 27.7
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    7. Secondary Outcome
    Title Change From Baseline in Alopecia Facial Hair Appearance Assessment (AFHA)-Clinician Reported Outcome, Left Eyebrow
    Description The Alopecia Facial Hair Appearance Assessment (AFHA)-Clinician Reported Outcome is the investigator's assessment of the subject's facial hair (eyebrow(s), eyelashes,and if male, beard) at a particular point in time. The investigator was instructed to NOT refer to any other assessments to assist with these assessments. The investigator or designee assessed the affected facial hair areas (eyebrows, eyelashes and if male, beard) using a 5 point scale for each target area [1-Full (Target Area Hair); 2-Most (Target Area Hair); 3-Some (Target Area Hair); 4-A Little (Target Area Hair); 5-No (Target Area Hair)]. Change status is categorized as 'Better by x points' when the score decreases from baseline by x points, and as 'Worse by x points' when the score increases by x points.
    Time Frame Baseline-Week 24

    Outcome Measure Data

    Analysis Population Description
    Intent-to-treat population using Last Observation Carried Forward to address missing data.
    Arm/Group Title ATI-501 400mg BID ATI-501 600mg BID ATI-501 800mg BID Placebo
    Arm/Group Description ATI-501 400mg BID (low dose) - oral administration ATI-501 Low dose ATI-501 600mg BID (mid dose) - oral administration ATI-501 Mid dose ATI-501 800mg BID (high dose) - oral administration ATI-501 high dose Placebo - oral administration
    Measure Participants 23 23 22 19
    Better by 4 points
    0
    0%
    1
    4.3%
    1
    4.5%
    0
    0%
    Better by 3 points
    1
    4.3%
    0
    0%
    1
    4.5%
    1
    5.3%
    Better by 2 points
    0
    0%
    2
    8.7%
    2
    9.1%
    1
    5.3%
    Better by 1 point
    4
    17.4%
    5
    21.7%
    6
    27.3%
    3
    15.8%
    No change
    15
    65.2%
    15
    65.2%
    10
    45.5%
    13
    68.4%
    Worse by 1 point
    1
    4.3%
    0
    0%
    1
    4.5%
    1
    5.3%
    Worse by 2 points
    2
    8.7%
    0
    0%
    0
    0%
    0
    0%
    Worse by 3 points
    0
    0%
    0
    0%
    1
    4.5%
    0
    0%
    Worse by 4 points
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection ATI-501 400mg BID Dosing, Placebo
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.471
    Comments
    Method Wilcoxon (Mann-Whitney)
    Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection ATI-501 600mg BID Dosing, Placebo
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.457
    Comments
    Method Wilcoxon (Mann-Whitney)
    Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection ATI-501 800mg BID Dosing, Placebo
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.367
    Comments
    Method Wilcoxon (Mann-Whitney)
    Comments
    8. Secondary Outcome
    Title Change From Baseline in Alopecia Facial Hair Appearance Assessment (AFHA)-Clinician Reported Outcome, Right Eyebrow
    Description The Alopecia Facial Hair Appearance Assessment (AFHA)-Clinician Reported Outcome is the investigator's assessment of the subject's facial hair (eyebrow(s), eyelashes,and if male, beard) at a particular point in time. The investigator was instructed to NOT refer to any other assessments to assist with these assessments. The investigator or designee assessed the affected facial hair areas (eyebrows, eyelashes and if male, beard) using a 5 point scale for each target area [1-Full (Target Area Hair); 2-Most (Target Area Hair); 3-Some (Target Area Hair); 4-A Little (Target Area Hair); 5-No (Target Area Hair)]. Change status is categorized as 'Better by x points' when the score decreases from baseline by x points, and as 'Worse by x points' when the score increases by x points.
    Time Frame Baseline-Week 24

    Outcome Measure Data

    Analysis Population Description
    Intent-to-treat population using Last Observation Carried Forward to address missing data.
    Arm/Group Title ATI-501 400mg BID ATI-501 600mg BID ATI-501 800mg BID Placebo
    Arm/Group Description ATI-501 400mg BID (low dose) - oral administration ATI-501 Low dose ATI-501 600mg BID (mid dose) - oral administration ATI-501 Mid dose ATI-501 800mg BID (high dose) - oral administration ATI-501 high dose Placebos - oral administration
    Measure Participants 23 23 22 19
    Better by 4 points
    0
    0%
    1
    4.3%
    1
    4.5%
    0
    0%
    Better by 3 points
    1
    4.3%
    0
    0%
    1
    4.5%
    1
    5.3%
    Better by 2 points
    0
    0%
    0
    0%
    3
    13.6%
    1
    5.3%
    Better by 1 point
    3
    13%
    6
    26.1%
    4
    18.2%
    4
    21.1%
    No change
    17
    73.9%
    12
    52.2%
    12
    54.5%
    13
    68.4%
    Worse by 1 point
    1
    4.3%
    4
    17.4%
    0
    0%
    0
    0%
    Worse by 2 points
    1
    4.3%
    0
    0%
    0
    0%
    0
    0%
    Worse by 3 points
    0
    0%
    0
    0%
    1
    4.5%
    0
    0%
    Worse by 4 points
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection ATI-501 400mg BID Dosing, Placebo
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.187
    Comments
    Method Wilcoxon (Mann-Whitney)
    Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection ATI-501 600mg BID Dosing, Placebo
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.375
    Comments
    Method Wilcoxon (Mann-Whitney)
    Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection ATI-501 800mg BID Dosing, Placebo
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.581
    Comments
    Method Wilcoxon (Mann-Whitney)
    Comments
    9. Secondary Outcome
    Title Change From Baseline in Alopecia Facial Hair Appearance Assessment (AFHA)-Clinician Reported Outcome, Left Eyelash
    Description The Alopecia Facial Hair Appearance Assessment (AFHA)-Clinician Reported Outcome is the investigator's assessment of the subject's facial hair (eyebrow(s), eyelashes,and if male, beard) at a particular point in time. The investigator was instructed to NOT refer to any other assessments to assist with these assessments. The investigator or designee assessed the affected facial hair areas (eyebrows, eyelashes and if male, beard) using a 5 point scale for each target area [1-Full (Target Area Hair); 2-Most (Target Area Hair); 3-Some (Target Area Hair); 4-A Little (Target Area Hair); 5-No (Target Area Hair)]. Change status is categorized as 'Better by x points' when the score decreases from baseline by x points, and as 'Worse by x points' when the score increases by x points.
    Time Frame Baseline-Week 24

    Outcome Measure Data

    Analysis Population Description
    Intent-to-treat population using Last Observation Carried Forward to address missing data.
    Arm/Group Title ATI-501 400mg BID ATI-501 600mg BID ATI-501 800mg BID Placebo
    Arm/Group Description ATI-501 400mg BID (low dose) - oral administration ATI-501 Low dose ATI-501 600mg BID - oral administration ATI-501 Mid dose ATI-501 800mg BID (high dose) - oral administration ATI-501 high dose Placebos - oral administration
    Measure Participants 23 23 22 19
    Better by 4 points
    1
    4.3%
    1
    4.3%
    0
    0%
    0
    0%
    Better by 3 points
    1
    4.3%
    0
    0%
    2
    9.1%
    1
    5.3%
    Better by 2 points
    1
    4.3%
    1
    4.3%
    3
    13.6%
    0
    0%
    Better by 1 point
    3
    13%
    3
    13%
    3
    13.6%
    1
    5.3%
    No Change
    15
    65.2%
    15
    65.2%
    12
    54.5%
    16
    84.2%
    Worse by 1 point
    0
    0%
    3
    13%
    1
    4.5%
    1
    5.3%
    Worse by 2 points
    1
    4.3%
    0
    0%
    0
    0%
    0
    0%
    Worse by 3 points
    1
    4.3%
    0
    0%
    1
    4.5%
    0
    0%
    Worse by 4 points
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection ATI-501 400mg BID Dosing, Placebo
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.444
    Comments
    Method Wilcoxon (Mann-Whitney)
    Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection ATI-501 600mg BID Dosing, Placebo
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.861
    Comments
    Method Wilcoxon (Mann-Whitney)
    Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection ATI-501 800mg BID Dosing, Placebo
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.182
    Comments
    Method Wilcoxon (Mann-Whitney)
    Comments
    10. Secondary Outcome
    Title Change From Baseline in Alopecia Facial Hair Appearance Assessment (AFHA)-Clinician Reported Outcome, Right Eyelash
    Description The Alopecia Facial Hair Appearance Assessment (AFHA)-Clinician Reported Outcome is the investigator's assessment of the subject's facial hair (eyebrow(s), eyelashes,and if male, beard) at a particular point in time. The investigator was instructed to NOT refer to any other assessments to assist with these assessments. The investigator or designee assessed the affected facial hair areas (eyebrows, eyelashes and if male, beard) using a 5 point scale for each target area [1-Full (Target Area Hair); 2-Most (Target Area Hair); 3-Some (Target Area Hair); 4-A Little (Target Area Hair); 5-No (Target Area Hair)]. Change status is categorized as 'Better by x points' when the score decreases from baseline by x points, and as 'Worse by x points' when the score increases by x points.
    Time Frame Baseline-Week 24

    Outcome Measure Data

    Analysis Population Description
    Intent-to-treat population using Last Observation Carried Forward to address missing data.
    Arm/Group Title ATI-501 400mg BID ATI-501 600mg BID ATI-501 800mg BID Placebo
    Arm/Group Description ATI-501 400mg BID (low dose) - oral administration ATI-501 Low dose ATI-501 600mg BID (mid dose) - oral administration ATI-501 Mid dose ATI-501 800mg BID (high dose) - oral administration ATI-501 high dose Placebos - oral administration
    Measure Participants 23 23 22 19
    Better by 4 points
    1
    4.3%
    1
    4.3%
    0
    0%
    0
    0%
    Better by 3 points
    1
    4.3%
    0
    0%
    1
    4.5%
    1
    5.3%
    Better by 2 points
    1
    4.3%
    1
    4.3%
    3
    13.6%
    0
    0%
    Better by 1 point
    3
    13%
    4
    17.4%
    4
    18.2%
    1
    5.3%
    No Change
    16
    69.6%
    16
    69.6%
    13
    59.1%
    16
    84.2%
    Worse by 1 point
    0
    0%
    1
    4.3%
    0
    0%
    1
    5.3%
    Worse by 2 points
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Worse by 3 points
    1
    4.3%
    0
    0%
    1
    4.5%
    0
    0%
    Worse by 4 points
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection ATI-501 400mg BID Dosing, Placebo
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.258
    Comments
    Method Wilcoxon (Mann-Whitney)
    Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection ATI-501 600mg BID Dosing, Placebo
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.263
    Comments
    Method Wilcoxon (Mann-Whitney)
    Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection ATI-501 800mg BID Dosing, Placebo
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.101
    Comments
    Method Wilcoxon (Mann-Whitney)
    Comments
    11. Secondary Outcome
    Title Change From Baseline in Alopecia Facial Hair Appearance Assessment (AFHA)-Clinician Reported Outcome, Beard, Male Subjects
    Description The Alopecia Facial Hair Appearance Assessment (AFHA)-Clinician Reported Outcome is the investigator's assessment of the subject's facial hair (eyebrow(s), eyelashes,and if male, beard) at a particular point in time. The investigator was instructed to NOT refer to any other assessments to assist with these assessments. The investigator or designee assessed the affected facial hair areas (eyebrows, eyelashes and if male, beard) using a 5 point scale for each target area [1-Full (Target Area Hair); 2-Most (Target Area Hair); 3-Some (Target Area Hair); 4-A Little (Target Area Hair); 5-No (Target Area Hair)]. Change status is categorized as 'Better by x points' when the score decreases from baseline by x points, and as 'Worse by x points' when the score increases by x points.
    Time Frame Baseline-Week 24

    Outcome Measure Data

    Analysis Population Description
    Intent-to-treat population using Last Observation Carried Forward to address missing data.
    Arm/Group Title ATI-501 400mg BID ATI-501 600mg BID ATI-501 800mg BID Placebo
    Arm/Group Description ATI-501 400mg BID (low dose) - oral administration ATI-501 Low dose ATI-501 600mg BID (mid dose) - oral administration ATI-501 Mid dose ATI-501 800mg BID (high dose) - oral administration ATI-501 high dose Placebos - oral administration
    Measure Participants 6 11 9 5
    Better by 4 points
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Better by 3 points
    0
    0%
    1
    4.3%
    3
    13.6%
    0
    0%
    Better by 2 points
    0
    0%
    0
    0%
    3
    13.6%
    0
    0%
    Better by 1 point
    2
    8.7%
    1
    4.3%
    0
    0%
    2
    10.5%
    No Change
    4
    17.4%
    6
    26.1%
    2
    9.1%
    3
    15.8%
    Worse by 1 point
    0
    0%
    2
    8.7%
    1
    4.5%
    0
    0%
    Worse by 2 points
    0
    0%
    1
    4.3%
    0
    0%
    0
    0%
    Worse by 3 points
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Worse by 4 points
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection ATI-501 400mg BID Dosing, Placebo
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value >0.999
    Comments
    Method Wilcoxon (Mann-Whitney)
    Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection ATI-501 600mg BID Dosing, Placebo
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.277
    Comments
    Method Wilcoxon (Mann-Whitney)
    Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection ATI-501 800mg BID Dosing, Placebo
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.159
    Comments
    Method Wilcoxon (Mann-Whitney)
    Comments
    12. Secondary Outcome
    Title Change From Baseline in Alopecia Facial Hair Appearance Assessment (AFHA)-Patient Reported Outcome, Left Eyebrow
    Description The Alopecia Facial Hair Appearance Assessment (AFHA)-Patient Reported Outcome is the patient's assessment of their facial hair (eyebrow(s), eyelashes, and if male, beard) at a particular point in time. The patient assessed the affected facial hair areas (eyebrows, eyelashes and if male, beard) using a 5 point scale for each target area [1-Full (Target Area Hair); 2-Most (Target Area Hair); 3-Some (Target Area Hair); 4-A Little (Target Area Hair); 5-No (Target Area Hair)]. Change status is categorized as 'Better by x points' when the score decreases from baseline by x points, and as 'Worse by x points' when the score increases by x points.
    Time Frame Baseline-Week 24

    Outcome Measure Data

    Analysis Population Description
    Intent-to-treat population using Last Observation Carried Forward to address missing data.
    Arm/Group Title ATI-501 400mg BID ATI-501 600mg BID ATI-501 800mg BID Placebo
    Arm/Group Description ATI-501 400mg BID (low dose) - oral administration ATI-501 Low dose ATI-501 600mg BID (mid dose) - oral administration ATI-501 Mid dose ATI-501 800mg BID (high dose) - oral administration ATI-501 high dose Placebo - oral administration
    Measure Participants 23 23 22 19
    Better by 4 points
    0
    0%
    1
    4.3%
    0
    0%
    0
    0%
    Better by 3 points
    1
    4.3%
    0
    0%
    2
    9.1%
    0
    0%
    Better by 2 points
    4
    17.4%
    0
    0%
    0
    0%
    1
    5.3%
    Better by 1 points
    1
    4.3%
    5
    21.7%
    8
    36.4%
    3
    15.8%
    No Change
    16
    69.6%
    14
    60.9%
    10
    45.5%
    13
    68.4%
    Worse by 1 point
    1
    4.3%
    3
    13%
    1
    4.5%
    2
    10.5%
    Worse by 2 points
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Worse by 3 points
    0
    0%
    0
    0%
    1
    4.5%
    0
    0%
    Worse by 4 points
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection ATI-501 400mg BID Dosing, Placebo
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.407
    Comments
    Method Wilcoxon (Mann-Whitney)
    Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection ATI-501 600mg BID Dosing, Placebo
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.894
    Comments
    Method Wilcoxon (Mann-Whitney)
    Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection ATI-501 800mg BID Dosing, Placebo
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.179
    Comments
    Method Wilcoxon (Mann-Whitney)
    Comments
    13. Secondary Outcome
    Title Change From Baseline in Alopecia Facial Hair Appearance Assessment (AFHA)-Patient Reported Outcome, Right Eyebrow
    Description The Alopecia Facial Hair Appearance Assessment (AFHA)-Patient Reported Outcome is the patient's assessment of their facial hair (eyebrow(s), eyelashes, and if male, beard) at a particular point in time. The patient assessed the affected facial hair areas (eyebrows, eyelashes and if male, beard) using a 5 point scale for each target area [1-Full (Target Area Hair); 2-Most (Target Area Hair); 3-Some (Target Area Hair); 4-A Little (Target Area Hair); 5-No (Target Area Hair)]. Change status is categorized as 'Better by x points' when the score decreases from baseline by x points, and as 'Worse by x points' when the score increases by x points.
    Time Frame Baseline-Week 24

    Outcome Measure Data

    Analysis Population Description
    Intent-to-treat population using Last Observation Carried Forward to address missing data.
    Arm/Group Title ATI-501 400mg BID ATI-501 600mg BID ATI-501 800mg BID Placebo
    Arm/Group Description ATI-501 400mg BID (low dose) - oral administration ATI-501 Low dose ATI-501 600mg BID (mid dose) - oral administration ATI-501 Mid dose ATI-501 800mg BID (high dose) - oral administration ATI-501 high dose Placebo - oral administration
    Measure Participants 23 23 22 19
    Better by 4 points
    0
    0%
    1
    4.3%
    0
    0%
    0
    0%
    Better by 3 points
    1
    4.3%
    0
    0%
    1
    4.5%
    0
    0%
    Better by 2 points
    2
    8.7%
    2
    8.7%
    2
    9.1%
    1
    5.3%
    Better by 1 point
    3
    13%
    5
    21.7%
    7
    31.8%
    4
    21.1%
    No Change
    16
    69.6%
    13
    56.5%
    10
    45.5%
    12
    63.2%
    Worse by 1 point
    0
    0%
    2
    8.7%
    1
    4.5%
    2
    10.5%
    Worse by 2 points
    1
    4.3%
    0
    0%
    0
    0%
    0
    0%
    Worse by 3 points
    0
    0%
    0
    0%
    1
    4.5%
    0
    0%
    Worse by 4 points
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection ATI-501 400mg BID Dosing, Placebo
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.691
    Comments
    Method Wilcoxon (Mann-Whitney)
    Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection ATI-501 600mg BID Dosing, Placebo
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.521
    Comments
    Method Wilcoxon (Mann-Whitney)
    Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection ATI-501 800mg BID Dosing, Placebo
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.262
    Comments
    Method Wilcoxon (Mann-Whitney)
    Comments
    14. Secondary Outcome
    Title Change From Baseline in Alopecia Facial Hair Appearance Assessment (AFHA)-Patient Reported Outcome, Right Eyelash
    Description The Alopecia Facial Hair Appearance Assessment (AFHA)-Patient Reported Outcome is the patient's assessment of their facial hair (eyebrow(s), eyelashes, and if male, beard) at a particular point in time. The patient assessed the affected facial hair areas (eyebrows, eyelashes and if male, beard) using a 5 point scale for each target area [1-Full (Target Area Hair); 2-Most (Target Area Hair); 3-Some (Target Area Hair); 4-A Little (Target Area Hair); 5-No (Target Area Hair)]. Change status is categorized as 'Better by x points' when the score decreases from baseline by x points, and as 'Worse by x points' when the score increases by x points.
    Time Frame Baseline-Week 24

    Outcome Measure Data

    Analysis Population Description
    Intent-to-treat population using Last Observation Carried Forward to address missing data.
    Arm/Group Title ATI-501 400mg BID ATI-501 600mg BID ATI-501 800mg BID Placebo
    Arm/Group Description ATI-501 400mg BID (low dose) - oral administration ATI-501 Low dose ATI-501 600mg BID (mid dose) - oral administration ATI-501 Mid dose: ATI-501 oral low dose ATI-501 800mg BID (high dose) - oral administration ATI-501 high dose Placebo - oral administration
    Measure Participants 23 23 22 19
    Better by 4 points
    1
    4.3%
    1
    4.3%
    0
    0%
    0
    0%
    Better by 3 points
    0
    0%
    1
    4.3%
    1
    4.5%
    0
    0%
    Better by 2 points
    2
    8.7%
    1
    4.3%
    2
    9.1%
    0
    0%
    Better by 1 point
    7
    30.4%
    3
    13%
    4
    18.2%
    2
    10.5%
    No Change
    13
    56.5%
    16
    69.6%
    12
    54.5%
    15
    78.9%
    Worse by 1 point
    0
    0%
    1
    4.3%
    1
    4.5%
    2
    10.5%
    Worse by 2 points
    0
    0%
    0
    0%
    1
    4.5%
    0
    0%
    Worse by 3 points
    0
    0%
    0
    0%
    1
    4.5%
    0
    0%
    Worse by 4 points
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection ATI-501 400mg BID Dosing, Placebo
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.009
    Comments
    Method Wilcoxon (Mann-Whitney)
    Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection ATI-501 600mg BID Dosing, Placebo
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.154
    Comments
    Method Wilcoxon (Mann-Whitney)
    Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection ATI-501 800mg BID Dosing, Placebo
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.289
    Comments
    Method Wilcoxon (Mann-Whitney)
    Comments
    15. Secondary Outcome
    Title Change From Baseline in Alopecia Facial Hair Appearance Assessment (AFHA)-Patient Reported Outcome, Left Eyelash
    Description The Alopecia Facial Hair Appearance Assessment (AFHA)-Patient Reported Outcome is the patient's assessment of their facial hair (eyebrow(s), eyelashes, and if male, beard) at a particular point in time. The patient assessed the affected facial hair areas (eyebrows, eyelashes and if male, beard) using a 5 point scale for each target area [1-Full (Target Area Hair); 2-Most (Target Area Hair); 3-Some (Target Area Hair); 4-A Little (Target Area Hair); 5-No (Target Area Hair)]. Change status is categorized as 'Better by x points' when the score decreases from baseline by x points, and as 'Worse by x points' when the score increases by x points.
    Time Frame Baseline-Week 24

    Outcome Measure Data

    Analysis Population Description
    Intent-to-treat population using Last Observation Carried Forward to address missing data.
    Arm/Group Title ATI-501 400mg BID ATI-501 600mg BID ATI-501 800mg BID Placebo
    Arm/Group Description ATI-501 400mg BID (low dose) - oral administration ATI-501 Low dose ATI-501 600mg BID (mid dose) - oral administration ATI-501 Mid dose ATI-501 800mg BID (high dose) - oral administration ATI-501 high dose Placebo - oral administration
    Measure Participants 23 23 22 19
    Better by 4 points
    1
    4.3%
    1
    4.3%
    0
    0%
    0
    0%
    Better by 3 points
    0
    0%
    1
    4.3%
    1
    4.5%
    0
    0%
    Better by 2 points
    2
    8.7%
    2
    8.7%
    2
    9.1%
    0
    0%
    Better by 1 point
    6
    26.1%
    1
    4.3%
    2
    9.1%
    3
    15.8%
    No Change
    13
    56.5%
    15
    65.2%
    14
    63.6%
    14
    73.7%
    Worse by 1 point
    0
    0%
    3
    13%
    2
    9.1%
    2
    10.5%
    Worse by 2 points
    0
    0%
    0
    0%
    1
    4.5%
    0
    0%
    Worse by 3 points
    1
    4.3%
    0
    0%
    0
    0%
    0
    0%
    Worse by 4 points
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection ATI-501 400mg BID Dosing, Placebo
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.073
    Comments
    Method Wilcoxon (Mann-Whitney)
    Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection ATI-501 600mg BID Dosing, Placebo
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.660
    Comments
    Method Wilcoxon (Mann-Whitney)
    Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection ATI-501 800mg BID Dosing, Placebo
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.704
    Comments
    Method Wilcoxon (Mann-Whitney)
    Comments
    16. Secondary Outcome
    Title Change From Baseline in Alopecia Facial Hair Appearance Assessment (AFHA)-Patient Reported Outcome, Beard, Male Subjects
    Description The Alopecia Facial Hair Appearance Assessment (AFHA)-Patient Reported Outcome is the patient's assessment of their facial hair (eyebrow(s), eyelashes, and if male, beard) at a particular point in time. The patient assessed the affected facial hair areas (eyebrows, eyelashes and if male, beard) using a 5 point scale for each target area [1-Full (Target Area Hair); 2-Most (Target Area Hair); 3-Some (Target Area Hair); 4-A Little (Target Area Hair); 5-No (Target Area Hair)]. Change status is categorized as 'Better by x points' when the score decreases from baseline by x points, and as 'Worse by x points' when the score increases by x points.
    Time Frame Baseline-Week 24

    Outcome Measure Data

    Analysis Population Description
    Intent-to-treat population using Last Observation Carried Forward to address missing data.
    Arm/Group Title ATI-501 400mg BID ATI-501 600mg BID ATI-501 800mg BID Placebo
    Arm/Group Description ATI-501 400mg BID (low dose) - oral administration ATI-501 Low dose ATI-501 600mg BID (mid dose) - oral administration ATI-501 Mid dose ATI-501 800mg BID (high dose) - oral administration ATI-501 high dose Placebo - oral administration
    Measure Participants 6 11 9 5
    Better by 4 points
    0
    0%
    1
    4.3%
    0
    0%
    0
    0%
    Better by 3 points
    0
    0%
    0
    0%
    1
    4.5%
    0
    0%
    Better by 2 points
    0
    0%
    1
    4.3%
    3
    13.6%
    0
    0%
    Better by 1 point
    2
    8.7%
    3
    13%
    3
    13.6%
    2
    10.5%
    No Change
    4
    17.4%
    5
    21.7%
    2
    9.1%
    3
    15.8%
    Worse by 1 point
    0
    0%
    1
    4.3%
    0
    0%
    0
    0%
    Worse by 2 points
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Worse by 3 points
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Worse by 4 points
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection ATI-501 400mg BID Dosing, Placebo
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value >0.999
    Comments
    Method Wilcoxon (Mann-Whitney)
    Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection ATI-501 600mg BID Dosing, Placebo
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.911
    Comments
    Method Wilcoxon (Mann-Whitney)
    Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection ATI-501 800mg BID Dosing, Placebo
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.110
    Comments
    Method Wilcoxon (Mann-Whitney)
    Comments
    17. Secondary Outcome
    Title Change From Baseline in the Subject Global Impression of Severity (SGIS) at Week 24, Patchy Alopecia Areata
    Description The Subject Global Impression of Severity (SGIS) is a 5-point descriptive scale completed by subjects to capture the subject's assessment of disease severity at a particular timepoint. Scores of 1 to 5 are assigned to responses Mild to Extremely Severe, respectively. Change status is categorized as 'Better by x points' when the score decreases from baseline by x points, and as 'Worse by x points' when the score increases by x points.
    Time Frame Baseline-Week 24

    Outcome Measure Data

    Analysis Population Description
    Intent-to-treat population using Last Observation Carried Forward to address missing data.
    Arm/Group Title ATI-501 400mg BID ATI-501 600mg BID ATI-501 800mg BID Placebo
    Arm/Group Description ATI-501 400mg BID (low dose) - oral administration ATI-501 Low dose ATI-501 600mg BID (mid dose) - oral administration ATI-501 Mid dose ATI-501 800mg BID (high dose) - oral administration ATI-501 high dose Placebo - oral administration
    Measure Participants 11 14 9 9
    Better by 4 points
    0
    0%
    1
    4.3%
    0
    0%
    0
    0%
    Better by 3 points
    2
    8.7%
    2
    8.7%
    0
    0%
    0
    0%
    Better by 2 points
    3
    13%
    2
    8.7%
    2
    9.1%
    1
    5.3%
    Better by 1 point
    1
    4.3%
    3
    13%
    3
    13.6%
    3
    15.8%
    No change
    3
    13%
    5
    21.7%
    3
    13.6%
    4
    21.1%
    Worse by 1 point
    0
    0%
    1
    4.3%
    1
    4.5%
    0
    0%
    Worse by 2 points
    2
    8.7%
    0
    0%
    0
    0%
    1
    5.3%
    Worse by 3 points
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Worse by 4 points
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection ATI-501 400mg BID Dosing, Placebo
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.430
    Comments
    Method Wilcoxon (Mann-Whitney)
    Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection ATI-501 600mg BID Dosing, Placebo
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.288
    Comments
    Method Wilcoxon (Mann-Whitney)
    Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection ATI-501 800mg BID Dosing, Placebo
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.582
    Comments
    Method Wilcoxon (Mann-Whitney)
    Comments
    18. Secondary Outcome
    Title Change From Baseline in the Subject Global Impression of Severity (SGIS) at Week 24, Alopecia Universalis or Alopecia Totalis
    Description The Subject Global Impression of Severity (SGIS) is a 5-point descriptive scale completed by subjects to capture the subject's assessment of disease severity at a particular timepoint. Scores of 1 to 5 are assigned to responses Mild to Extremely Severe, respectively. Change status is categorized as 'Better by x points' when the score decreases from baseline by x points, and as 'Worse by x points' when the score increases by x points.
    Time Frame Baseline-Week 24

    Outcome Measure Data

    Analysis Population Description
    Intent-to-treat population using Last Observation Carried Forward to address missing data. One patient was excluded from the analysis based on the visit windowing conventions that was previously established. This patient's Week 24 SGIS occurred at Day 128, which is outside of the window for inclusion of results at Week 24.
    Arm/Group Title ATI-501 400mg BID ATI-501 600mg BID ATI-501 800mg BID Placebo
    Arm/Group Description ATI-501 400mg BID (low dose) - oral administration ATI-501 Low dose ATI-501 600mg BID (mid dose) - oral administration ATI-501 Mid dose ATI-501 800mg BID (high dose) - oral administration ATI-501 high dose Placebo - oral administration
    Measure Participants 11 9 13 10
    Better by 4 points
    0
    0%
    1
    4.3%
    1
    4.5%
    0
    0%
    Better by 3 points
    1
    4.3%
    0
    0%
    3
    13.6%
    0
    0%
    Better by 2 points
    2
    8.7%
    1
    4.3%
    2
    9.1%
    0
    0%
    Better by 1 point
    2
    8.7%
    0
    0%
    3
    13.6%
    2
    10.5%
    No change
    6
    26.1%
    6
    26.1%
    4
    18.2%
    8
    42.1%
    Worse by 1 point
    0
    0%
    1
    4.3%
    0
    0%
    0
    0%
    Worse by 2 points
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Worse by 3 points
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Worse by 4 points
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection ATI-501 400mg BID Dosing, Placebo
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.194
    Comments
    Method Wilcoxon (Mann-Whitney)
    Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection ATI-501 600mg BID Dosing, Placebo
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value >0.999
    Comments
    Method Wilcoxon (Mann-Whitney)
    Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection ATI-501 800mg BID Dosing, Placebo
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.011
    Comments
    Method Wilcoxon (Mann-Whitney)
    Comments
    19. Secondary Outcome
    Title Change From Baseline in the Physician Global Impression of Severity (PhGIS) at Week 24, Patchy Alopecia Areata
    Description The Physician Global Impression of Severity (PhGIS) is a 5-point descriptive scale completed by investigators and is used to capture the investigator's assessment of the subject's disease severity at a particular timepoint. Scores of 1 to 5 are assigned to responses Mild to Extremely Severe, respectively. Change status is categorized as 'Better by x points' when the score decreases from baseline by x points, and as 'Worse by x points' when the score increases by x points.
    Time Frame Baseline-Week 24

    Outcome Measure Data

    Analysis Population Description
    Intent-to-treat population using Last Observation Carried Forward to address missing data.
    Arm/Group Title ATI-501 400mg BID ATI-501 600mg BID ATI-501 800mg BID Placebo
    Arm/Group Description ATI-501 400mg BID (low dose) - oral administration ATI-501 Low dose ATI-501 600mg BID (mid dose) - oral administration ATI-501 Mid dose ATI-501 800mg BID (high dose) - oral administration ATI-501 high dose Placebo - oral administration
    Measure Participants 11 14 9 9
    Better by 4 points
    0
    0%
    1
    4.3%
    0
    0%
    0
    0%
    Better by 3 points
    1
    4.3%
    0
    0%
    0
    0%
    0
    0%
    Better by 2 points
    3
    13%
    4
    17.4%
    1
    4.5%
    0
    0%
    Better by 1 point
    1
    4.3%
    3
    13%
    2
    9.1%
    3
    15.8%
    No Change
    5
    21.7%
    4
    17.4%
    6
    27.3%
    4
    21.1%
    Worse by 1 point
    1
    4.3%
    2
    8.7%
    0
    0%
    2
    10.5%
    Worse by 2 points
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Worse by 3 points
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Worse by 4 points
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection ATI-501 400mg BID Dosing, Placebo
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.248
    Comments
    Method Wilcoxon (Mann-Whitney)
    Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection ATI-501 600mg BID Dosing, Placebo
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.150
    Comments
    Method Wilcoxon (Mann-Whitney)
    Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection ATI-501 800mg BID Dosing, Placebo
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.546
    Comments
    Method Wilcoxon (Mann-Whitney)
    Comments
    20. Secondary Outcome
    Title Change From Baseline in the Physician Global Impression of Severity (PhGIS) at Week 24, Alopecia Universalis or Alopecia Totalis
    Description The Physician Global Impression of Severity (PhGIS) is a 5-point descriptive scale completed by investigators and is used to capture the investigator's assessment of the subject's disease severity at a particular timepoint. Scores of 1 to 5 are assigned to responses Mild to Extremely Severe, respectively. Change status is categorized as 'Better by x points' when the score decreases from baseline by x points, and as 'Worse by x points' when the score increases by x points.
    Time Frame Baseline-Week 24

    Outcome Measure Data

    Analysis Population Description
    Intent-to-treat population using Last Observation Carried Forward to address missing data.
    Arm/Group Title ATI-501 400mg BID ATI-501 600mg BID ATI-501 800mg BID Placebo
    Arm/Group Description ATI-501 400mg BID (low dose) - oral administration ATI-501 Low dose ATI-501 600mg BID (mid dose) - oral administration ATI-501 Mid dose ATI-501 800mg BID (high dose) - oral administration ATI-501 high dose Placebo - oral administration
    Measure Participants 12 9 13 10
    Better by 4 points
    0
    0%
    1
    4.3%
    1
    4.5%
    0
    0%
    Better by 3 points
    1
    4.3%
    0
    0%
    2
    9.1%
    0
    0%
    Better by 2 points
    0
    0%
    1
    4.3%
    2
    9.1%
    0
    0%
    Better by 1 point
    5
    21.7%
    0
    0%
    3
    13.6%
    3
    15.8%
    No change
    6
    26.1%
    7
    30.4%
    5
    22.7%
    7
    36.8%
    Worse by 1 point
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Worse by 2 points
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Worse by 3 points
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Worse by 4 points
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection ATI-501 400mg BID Dosing, Placebo
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.341
    Comments
    Method Wilcoxon (Mann-Whitney)
    Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection ATI-501 600mg BID Dosing, Placebo
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value >0.999
    Comments
    Method Wilcoxon (Mann-Whitney)
    Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection ATI-501 800mg BID Dosing, Placebo
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.068
    Comments
    Method Wilcoxon (Mann-Whitney)
    Comments
    21. Secondary Outcome
    Title Alopecia Impact Assessment (AIA) Patient Reported Outcome Change From Baseline at Week 24
    Description The Alopecia Impact Assessment (AIA) is a 13-item patient reported outcome questionnaire which measures the subject's experience with impacts related to alopecia (inclusive of all 3 subtypes observed on study) in managing appearance, worry, sadness, loss of confidence, self-consciousness, embarrassment, feeling unattractive, limitation of social activities, limitation of physical activities, unwanted attention, sweat in eyes, debris in eyes, and debris in nose. The AIA has a recall period of "over the past seven days". An 11-point NRS with anchors "0 - Not at all [impact]" and "10 - Extremely [impact]" (e.g., "Not at all bothersome" and "Extremely bothersome"; "Not at all worried" and "Extremely worried") is utilized. The AIA produces single-item (0-10) and mean total (0-10) scores, with higher scores indicating higher levels of impact.
    Time Frame Baseline-Week 24

    Outcome Measure Data

    Analysis Population Description
    Intent-to-treat population using Last Observation Carried Forward to address missing data.
    Arm/Group Title ATI-501 400mg BID ATI-501 600mg BID ATI-501 800mg BID Placebo
    Arm/Group Description ATI-501 400mg BID (low dose) - oral administration ATI-501 Low dose ATI-501 600mg BID (mid dose) - oral administration ATI-501 Mid dose ATI-501 800mg BID (high dose) - oral administration ATI-501 high dose Placebo - oral administration
    Measure Participants 23 23 22 19
    Mean (Standard Deviation) [score on a scale]
    -1.9
    (1.89)
    -1.8
    (2.79)
    -1.2
    (1.80)
    -1.1
    (1.06)
    22. Secondary Outcome
    Title Subject Global Impression of Treatment Satisfaction (SGITS) at Week 24, Patchy Alopecia Areata
    Description The Subject Global Impression of Treatment Satisfaction (SGITS) is a 7-point descriptive scale completed by subjects. Scale response options ranged from "1. Extremely Satisfied" to "7. Extremely Dissatisfied" and are used to capture how satisfied or dissatisfied they are with the study medication treatment received for their alopecia areata.
    Time Frame Baseline-Week 24

    Outcome Measure Data

    Analysis Population Description
    Intent-to-treat population using Last Observation Carried Forward to address missing data.
    Arm/Group Title ATI-501 400mg BID ATI-501 600mg BID ATI-501 800mg BID Placebo
    Arm/Group Description ATI-501 400mg BID (low dose) - oral administration ATI-501 Low dose ATI-501 600mg BID (mid dose) - oral administration ATI-501 Mid dose ATI-501 800mg BID (high dose) - oral administration ATI-501 high dose Placebo - oral administration
    Measure Participants 10 11 8 8
    Extremely satisfied
    5
    21.7%
    5
    21.7%
    2
    9.1%
    1
    5.3%
    Moderately satisfied
    2
    8.7%
    2
    8.7%
    2
    9.1%
    0
    0%
    A little satisfied
    0
    0%
    0
    0%
    0
    0%
    1
    5.3%
    Neither satisfied or dissatisfied
    0
    0%
    2
    8.7%
    2
    9.1%
    2
    10.5%
    A little dissatisfied
    1
    4.3%
    0
    0%
    0
    0%
    1
    5.3%
    Moderately dissatisfied
    1
    4.3%
    1
    4.3%
    1
    4.5%
    1
    5.3%
    Extremely dissatisfied
    1
    4.3%
    1
    4.3%
    1
    4.5%
    2
    10.5%
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection ATI-501 400mg BID Dosing, Placebo
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.098
    Comments
    Method Wilcoxon (Mann-Whitney)
    Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection ATI-501 600mg BID Dosing, Placebo
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.082
    Comments
    Method Wilcoxon (Mann-Whitney)
    Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection ATI-501 800mg BID Dosing, Placebo
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.313
    Comments
    Method Wilcoxon (Mann-Whitney)
    Comments
    23. Secondary Outcome
    Title Subject Global Impression of Treatment Satisfaction (SGITS) at Week 24, Alopecia Universalis or Alopecia Totalis
    Description The Subject Global Impression of Treatment Satisfaction (SGITS) is a 7-point descriptive scale completed by subjects. Scale response options ranged from "1. Extremely Satisfied" to "7. Extremely Dissatisfied" and are used to capture how satisfied or dissatisfied they are with the study medication treatment received for their alopecia areata.
    Time Frame Baseline-Week 24

    Outcome Measure Data

    Analysis Population Description
    Intent-to-treat population using Last Observation Carried Forward to address missing data.
    Arm/Group Title ATI-501 400mg BID ATI-501 600mg BID ATI-501 800mg BID Placebo
    Arm/Group Description ATI-501 400mg BID (low dose) - oral administration ATI-501 Low dose ATI-501 600mg BID (mid dose) - oral administration ATI-501 Mid dose ATI-501 800mg BID (high dose) - oral administration ATI-501 high dose Placebo - oral administration
    Measure Participants 12 9 13 10
    Extremely satisfied
    1
    4.3%
    1
    4.3%
    3
    13.6%
    1
    5.3%
    Moderately satisfied
    3
    13%
    1
    4.3%
    5
    22.7%
    2
    10.5%
    A little satisfied
    1
    4.3%
    2
    8.7%
    1
    4.5%
    1
    5.3%
    Neither satisfied or dissatisfied
    4
    17.4%
    3
    13%
    1
    4.5%
    3
    15.8%
    A little dissatisfied
    1
    4.3%
    0
    0%
    0
    0%
    1
    5.3%
    Moderately dissatisfied
    1
    4.3%
    1
    4.3%
    1
    4.5%
    1
    5.3%
    Extremely dissatisfied
    1
    4.3%
    1
    4.3%
    2
    9.1%
    1
    5.3%
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection ATI-501 400mg BID Dosing, Placebo
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.883
    Comments
    Method Wilcoxon (Mann-Whitney)
    Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection ATI-501 600mg BID Dosing, Placebo
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.954
    Comments
    Method Wilcoxon (Mann-Whitney)
    Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection ATI-501 800mg BID Dosing, Placebo
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.295
    Comments
    Method Wilcoxon (Mann-Whitney)
    Comments
    24. Secondary Outcome
    Title Change From Baseline in the Subject Global Satisfaction With Hair Quality (SGSHQ) for Entire Scalp at Week 24, Patchy Alopecia Areata
    Description The investigator or study staff instructed the subject to answer the Subject Global Satisfaction with Hair Quality (SGSHQ) questionnaire in relation to their satisfaction with the quality of scalp hair at the time of questionnaire completion (ie "right now"). Subjects assessed their satisfaction with the quality of their scalp hair on a 7-point satisfaction scale from extremely satisfied to extremely dissatisfied at the visits. Change status is categorized as 'Better by x points' when the score decreases from baseline by x points, and as 'Worse by x points' when the score increases by x points.
    Time Frame Baseline-Week 24

    Outcome Measure Data

    Analysis Population Description
    Intent-to-treat population using Last Observation Carried Forward to address missing data.
    Arm/Group Title ATI-501 400mg BID ATI-501 600mg BID ATI-501 800mg BID Placebo
    Arm/Group Description ATI-501 400mg BID (low dose) - oral administration ATI-501 Low dose ATI-501 600mg BID (mid dose) - oral administration ATI-501 Mid dose ATI-501 800mg BID (high dose) - oral administration ATI-501 high dose Placebo - oral administration
    Measure Participants 11 14 9 7
    Better by 6 points
    4
    17.4%
    4
    17.4%
    0
    0%
    0
    0%
    Better by 5 points
    1
    4.3%
    0
    0%
    1
    4.5%
    0
    0%
    Better by 4 points
    0
    0%
    1
    4.3%
    2
    9.1%
    1
    5.3%
    Better by 3 points
    1
    4.3%
    0
    0%
    1
    4.5%
    1
    5.3%
    Better by 2 points
    0
    0%
    3
    13%
    0
    0%
    0
    0%
    Better by 1 points
    0
    0%
    2
    8.7%
    1
    4.5%
    1
    5.3%
    No change
    4
    17.4%
    4
    17.4%
    2
    9.1%
    4
    21.1%
    Worse by 1 point
    1
    4.3%
    0
    0%
    0
    0%
    0
    0%
    Worse by 2 points
    0
    0%
    0
    0%
    1
    4.5%
    0
    0%
    Worse by 3 points
    0
    0%
    0
    0%
    1
    4.5%
    0
    0%
    Worse by 4 points
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Worse by 5 points
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Worse by 6 points
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection ATI-501 400mg BID Dosing, Placebo
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.361
    Comments
    Method Wilcoxon (Mann-Whitney)
    Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection ATI-501 600mg BID Dosing, Placebo
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.182
    Comments
    Method Wilcoxon (Mann-Whitney)
    Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection ATI-501 800mg BID Dosing, Placebo
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.815
    Comments
    Method Wilcoxon (Mann-Whitney)
    Comments
    25. Secondary Outcome
    Title Change From Baseline in the Subject Global Satisfaction With Hair Quality (SGSHQ) for Entire Scalp at Week 24, Alopecia Universalis or Alopecia Totalis
    Description The investigator or study staff instructed the subject to answer the Subject Global Satisfaction with Hair Quality (SGSHQ) questionnaire in relation to their satisfaction with the quality of scalp hair at the time of questionnaire completion (ie "right now"). Subjects assessed their satisfaction with the quality of their scalp hair on a 7-point satisfaction scale from extremely satisfied to extremely dissatisfied at the visits. Change status is categorized as 'Better by x points' when the score decreases from baseline by x points, and as 'Worse by x points' when the score increases by x points.
    Time Frame Baseline-Week 24

    Outcome Measure Data

    Analysis Population Description
    Intent-to-treat population using Last Observation Carried Forward to address missing data.
    Arm/Group Title ATI-501 400mg BID ATI-501 600mg BID ATI-501 800mg BID Placebo
    Arm/Group Description ATI-501 400mg BID (low dose) - oral administration ATI-501 Low dose ATI-501 600mg BID (mid dose) - oral administration ATI-501 Mid dose ATI-501 800mg BID (high dose) - oral administration ATI-501 high dose Placebo - oral administration
    Measure Participants 12 9 13 10
    Better by 6 points
    0
    0%
    1
    4.3%
    0
    0%
    0
    0%
    Better by 5 points
    1
    4.3%
    0
    0%
    5
    22.7%
    0
    0%
    Better by 4 points
    2
    8.7%
    1
    4.3%
    0
    0%
    0
    0%
    Better by 3 points
    3
    13%
    3
    13%
    1
    4.5%
    2
    10.5%
    Better by 2 points
    0
    0%
    2
    8.7%
    0
    0%
    1
    5.3%
    Better by 1 point
    0
    0%
    0
    0%
    2
    9.1%
    2
    10.5%
    No change
    5
    21.7%
    1
    4.3%
    3
    13.6%
    5
    26.3%
    Worse by 1 point
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Worse by 2 points
    1
    4.3%
    0
    0%
    1
    4.5%
    0
    0%
    Worse by 3 points
    0
    0%
    0
    0%
    1
    4.5%
    0
    0%
    Worse by 4 points
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Worse by 5 points
    0
    0%
    1
    4.3%
    0
    0%
    0
    0%
    Worse by 6 points
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection ATI-501 400mg BID Dosing, Placebo
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.522
    Comments
    Method Wilcoxon (Mann-Whitney)
    Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection ATI-501 600mg BID Dosing, Placebo
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.104
    Comments
    Method Wilcoxon (Mann-Whitney)
    Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection ATI-501 800mg BID Dosing, Placebo
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.414
    Comments
    Method Wilcoxon (Mann-Whitney)
    Comments
    26. Secondary Outcome
    Title Change in Dermatology Life Quality Index Total Score (DLQI) Between Baseline and Week 24
    Description The 10 question Dermatology Life Quality Index (DLQI) questionnaire was completed by subjects at Baseline, Week 4, Week 12, and Week 24. When completing the questionnaire, subjects were instructed to think of their hair loss in place of "skin problem" and "skin" as referenced in the questionnaire. Possible summary scores could range from 0 to 30 with higher scores indicating a worse outcome.
    Time Frame Baseline-Week 24

    Outcome Measure Data

    Analysis Population Description
    Intent-to-treat population using Last Observation Carried Forward to address missing data.
    Arm/Group Title ATI-501 400mg BID ATI-501 600mg BID ATI-501 800mg BID Placebo
    Arm/Group Description ATI-501 400mg BID (low dose) - oral administration ATI-501 Low dose ATI-501 600mg BID (mid dose) - oral administration ATI-501 Mid dose ATI-501 800mg BID (high dose) - oral administration ATI-501 high dose Placebo - oral administration
    Measure Participants 23 23 22 19
    Mean (Standard Deviation) [score on a scale]
    -1.5
    (4.33)
    -5.3
    (5.21)
    -1.7
    (3.97)
    -1.7
    (5.99)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection ATI-501 400mg BID Dosing, Placebo
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.882
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Net)
    Estimated Value 0.21
    Confidence Interval (2-Sided) 95%
    -2.53 to 2.94
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.930
    Estimation Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection ATI-501 600mg BID Dosing, Placebo
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.011
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Net)
    Estimated Value -3.58
    Confidence Interval (2-Sided) 95%
    -6.31 to -0.84
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.930
    Estimation Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection ATI-501 800mg BID Dosing, Placebo
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.999
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Net)
    Estimated Value 0.00
    Confidence Interval (2-Sided) 95%
    -2.76 to 2.76
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.951
    Estimation Comments
    27. Secondary Outcome
    Title Subject Global Impression of Change (SGIC) at Week 24
    Description The Subject Global Impression of Change (SGIC) is a 7-point descriptive scale completed by subjects at Week 24 (Intent-to-treat population with reported data falling within the windowed Week 24 visit timeframe). Scale response options ranged from "1. Very much improved" to "7. Very much worse" and are used to capture the subject's overall impression of change for his/her alopecia during the treatment period.
    Time Frame Baseline-Week 24

    Outcome Measure Data

    Analysis Population Description
    Intent-to-treat population using Last Observation Carried Forward (LOCF) to address missing data. Per SAP, the allowed window days for Week 24 visit are 155-182. There were 4 patients in the 400mg group, 4 patients in the 600mg group, 3 patients in the 800mg group, and 5 patients in the placebo group who fell outside this window.
    Arm/Group Title ATI-501 400mg BID ATI-501 600mg BID ATI-501 800mg BID Placebo
    Arm/Group Description ATI-501 400mg BID (low dose) - oral administration ATI-501 Low dose ATI-501 600mg BID (mid dose) - oral administration ATI-501 Mid dose ATI-501 800mg BID (high dose) - oral administration ATI-501 high dose Placebo - oral administration
    Measure Participants 19 19 19 14
    Very much improved
    5
    21.7%
    6
    26.1%
    2
    9.1%
    1
    5.3%
    Much improved
    3
    13%
    1
    4.3%
    7
    31.8%
    1
    5.3%
    A little improved
    4
    17.4%
    5
    21.7%
    6
    27.3%
    6
    31.6%
    No change
    7
    30.4%
    7
    30.4%
    3
    13.6%
    6
    31.6%
    A little worse
    0
    0%
    0
    0%
    1
    4.5%
    0
    0%
    Much worse
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Very much worse
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection ATI-501 400mg BID Dosing, Placebo
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.270
    Comments
    Method Wilcoxon (Mann-Whitney)
    Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection ATI-501 600mg BID Dosing, Placebo
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.319
    Comments
    Method Wilcoxon (Mann-Whitney)
    Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection ATI-501 800mg BID Dosing, Placebo
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.094
    Comments
    Method Wilcoxon (Mann-Whitney)
    Comments
    28. Secondary Outcome
    Title Physician Global Impression of Change (PhGIC) at Week 24
    Description The Physician Global Impression of Change (PhGIC) is a 7-point descriptive scale completed by investigators at Week 24 (Intent-to-treat population with reported data falling within the windowed Week 24 visit timeframe). Scale response options ranged from "1. Very much improved" to "7. Very much worse" and are used to capture the investigator's overall impression of change for the subject's alopecia during the treatment period.
    Time Frame Baseline-Week 24

    Outcome Measure Data

    Analysis Population Description
    Intent-to-treat population using Last Observation Carried Forward (LOCF) to address missing data. Per SAP, the allowed window days for Week 24 visit are 155-182. There were 4 patients in the 400mg group, 4 patients in the 600mg group, 3 patients in the 800mg group, and 5 patients in the placebo group who fell outside this window.
    Arm/Group Title ATI-501 400mg BID ATI-501 600mg BID ATI-501 800mg BID Placebo
    Arm/Group Description ATI-501 400mg BID (low dose) - oral administration ATI-501 Low dose ATI-501 600mg BID (mid dose) - oral administration ATI-501 Mid dose ATI-501 800mg BID (high dose) - oral administration ATI-501 high dose Placebo - oral administration
    Measure Participants 19 19 19 14
    Very much improved
    5
    21.7%
    7
    30.4%
    3
    13.6%
    2
    10.5%
    Much improved
    3
    13%
    0
    0%
    6
    27.3%
    0
    0%
    A little improved
    2
    8.7%
    5
    21.7%
    5
    22.7%
    5
    26.3%
    No change
    8
    34.8%
    7
    30.4%
    4
    18.2%
    7
    36.8%
    A little worse
    1
    4.3%
    0
    0%
    1
    4.5%
    0
    0%
    Much worse
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Very much worse
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection ATI-501 400mg BID Dosing, Placebo
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.584
    Comments
    Method Wilcoxon (Mann-Whitney)
    Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection ATI-501 600mg BID Dosing, Placebo
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.287
    Comments
    Method Wilcoxon (Mann-Whitney)
    Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection ATI-501 800mg BID Dosing, Placebo
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.144
    Comments
    Method Wilcoxon (Mann-Whitney)
    Comments
    29. Secondary Outcome
    Title Change From Baseline in Alopecia Scalp Appearance Assessment (ASAA): Scalp-Clinician Reported Outcome for Target Patch, Patchy Alopecia Areata
    Description The Scalp Clinician Reported Outcome for Target Patch provides the investigator's assessment for Patchy Alopecia Areata (AAP) patients regarding the appearance of the patient's target patch (identified by the patient as his or her most bothersome area of scalp hair loss at Baseline). The assessment was completed by investigators at Baseline, Week 2, Week 12, and Week 24. The assessment has a recall period of "right now" and includes a five-point VRS ranging from "Full hair, scalp of the target patch completely covered with hair" to "no hair, scalp of the target patch completely exposed." The instrument produces a score of 1 to 5, with lower scores indicating more hair covering the patient's target patch. Change status is categorized as 'Better by x points' when the score decreases from baseline by x points, and as 'Worse by x points' when the score increases by x points.
    Time Frame Baseline-Week 24

    Outcome Measure Data

    Analysis Population Description
    Intent-to-treat population using Last Observation Carried Forward to address missing data.
    Arm/Group Title ATI-501 400mg BID ATI-501 600mg BID ATI-501 800mg BID Placebo
    Arm/Group Description ATI-501 400mg BID (low dose) - oral administration ATI-501 Low dose ATI-501 600mg BID (mid dose) - oral administration ATI-501 Mid dose ATI-501 800mg BID (high dose) - oral administration ATI-501 high dose Placebo - oral administration
    Measure Participants 11 14 9 8
    Better by 4 points
    0
    0%
    1
    4.3%
    1
    4.5%
    0
    0%
    Better by 3 points
    4
    17.4%
    5
    21.7%
    1
    4.5%
    2
    10.5%
    Better by 2 points
    1
    4.3%
    1
    4.3%
    0
    0%
    0
    0%
    Better by 1 point
    0
    0%
    3
    13%
    4
    18.2%
    0
    0%
    No change
    6
    26.1%
    2
    8.7%
    2
    9.1%
    5
    26.3%
    Worse by 1 point
    0
    0%
    2
    8.7%
    1
    4.5%
    1
    5.3%
    Worse by 2 points
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Worse by 3 points
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Worse by 4 points
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection ATI-501 400mg BID Dosing, Placebo
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.341
    Comments
    Method Wilcoxon (Mann-Whitney)
    Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection ATI-501 600mg BID Dosing, Placebo
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.203
    Comments
    Method Wilcoxon (Mann-Whitney)
    Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection ATI-501 800mg BID Dosing, Placebo
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.327
    Comments
    Method Wilcoxon (Mann-Whitney)
    Comments
    30. Secondary Outcome
    Title Change From Baseline in Alopecia Scalp Appearance Assessment (ASAA): Scalp-Clinician Reported Outcome for Entire Scalp, All Patients
    Description The Scalp Clinician Reported Outcome for Entire Scalp was completed for patients with Patchy Alopecia Areata, Alopecia Universalis, and Alopecia Totalis and assesses the appearance of the patient's whole scalp. The assessment was completed by investigators at Baseline, Week 2, Week 12, and Week 24. The assessment has a recall period of "right now" and includes a five-point VRS ranging from "Full hair, whole scalp completely covered with hair" to "no hair, whole scalp completely exposed." The instrument produces a score of 1 to 5, with lower scores indicating more hair covering the patient's whole scalp. Change status is categorized as 'Better by x points' when the score decreases from baseline by x points, and as 'Worse by x points' when the score increases by x points.
    Time Frame Baseline-Week 24

    Outcome Measure Data

    Analysis Population Description
    Intent-to-treat population using Last Observation Carried Forward to address missing data.
    Arm/Group Title ATI-501 400mg BID ATI-501 600mg BID ATI-501 800mg BID Placebo
    Arm/Group Description ATI-501 400mg BID (low dose) - oral administration ATI-501 Low dose ATI-501 600mg BID (mid dose) - oral administration ATI-501 Mid dose ATI-501 800mg BID (high dose) - oral administration ATI-501 high dose Placebo - oral administration
    Measure Participants 23 23 22 19
    Better by 4 points
    0
    0%
    1
    4.3%
    0
    0%
    0
    0%
    Better by 3 points
    1
    4.3%
    0
    0%
    1
    4.5%
    0
    0%
    Better by 2 points
    3
    13%
    2
    8.7%
    3
    13.6%
    1
    5.3%
    Better by 1 point
    7
    30.4%
    9
    39.1%
    8
    36.4%
    8
    42.1%
    No change
    11
    47.8%
    10
    43.5%
    10
    45.5%
    10
    52.6%
    Worse by 1 point
    1
    4.3%
    1
    4.3%
    0
    0%
    0
    0%
    Worse by 2 points
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Worse by 3 points
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Worse by 4 points
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection ATI-501 400mg BID Dosing, Placebo
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.827
    Comments
    Method Wilcoxon (Mann-Whitney)
    Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection ATI-501 600mg BID Dosing, Placebo
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.742
    Comments
    Method Wilcoxon (Mann-Whitney)
    Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection ATI-501 800mg BID Dosing, Placebo
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.462
    Comments
    Method Wilcoxon (Mann-Whitney)
    Comments
    31. Secondary Outcome
    Title Change From Baseline in Alopecia Scalp Appearance Assessment (ASAA): Scalp-Patient Reported Outcome for Target Patch, Patchy Alopecia Areata
    Description The Scalp Patient Reported Outcome for Target Patch was completed by patients with Patchy Alopecia Areata (AAP) and assesses the appearance of the subject's target patch (identified by the subject as his or her most bothersome area of scalp hair loss at Baseline). The assessment was completed by AAP subjects at Baseline, Week 2, Week 12, and Week 24. The assessment has a recall period of "right now" and includes a five-point VRS ranging from "Full hair, scalp of the target patch completely covered with hair" to "no hair, scalp of the target patch completely exposed." The instrument produces a score of 1 to 5, with lower scores indicating more hair covering the subject's target patch. Change status is categorized as 'Better by x points' when the score decreases from baseline by x points, and as 'Worse by x points' when the score increases by x points.
    Time Frame Baseline-Week 24

    Outcome Measure Data

    Analysis Population Description
    Intent-to-treat population using Last Observation Carried Forward to address missing data.
    Arm/Group Title ATI-501 400mg BID ATI-501 600mg BID ATI-501 800mg BID Placebo
    Arm/Group Description ATI-501 400mg BID (low dose) - oral administration ATI-501 Low dose ATI-501 600mg BID (mid dose) - oral administration ATI-501 Mid dose ATI-501 800mg BID (high dose) - oral administration ATI-501 high dose Placebo - oral administration
    Measure Participants 11 14 9 8
    Better by 4 points
    2
    8.7%
    1
    4.3%
    1
    4.5%
    0
    0%
    Better by 3 points
    3
    13%
    4
    17.4%
    1
    4.5%
    1
    5.3%
    Better by 2 points
    1
    4.3%
    3
    13%
    0
    0%
    1
    5.3%
    Better by 1 point
    0
    0%
    2
    8.7%
    4
    18.2%
    5
    26.3%
    No change
    4
    17.4%
    1
    4.3%
    2
    9.1%
    1
    5.3%
    Worse by 1 point
    1
    4.3%
    3
    13%
    1
    4.5%
    0
    0%
    Worse by 2 points
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Worse by 3 points
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Worse by 4 points
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection ATI-501 400mg BID Dosing, Placebo
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.836
    Comments
    Method Wilcoxon (Mann-Whitney)
    Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection ATI-501 600mg BID Dosing, Placebo
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.540
    Comments
    Method Wilcoxon (Mann-Whitney)
    Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection ATI-501 800mg BID Dosing, Placebo
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.672
    Comments
    Method Wilcoxon (Mann-Whitney)
    Comments
    32. Secondary Outcome
    Title Change From Baseline in Alopecia Scalp Appearance Assessment (ASAA): Scalp-Patient Reported Outcome for Entire Scalp, All Patients
    Description The Scalp Patient Reported Outcome for Entire Scalp was completed by patients with Patchy Alopecia Areata, Alopecia Universalis, and Alopecia Totalis and assesses the appearance of the patient's whole scalp. The assessment was completed by patients at Baseline, Week 2, Week 12, and Week 24. The assessment has a recall period of "right now" and includes a five-point VRS ranging from "Full hair, whole scalp completely covered with hair" to "no hair, whole scalp completely exposed." The instrument produces a score of 1 to 5, with lower scores indicating more hair covering the patient's target patch. Change status is categorized as 'Better by x points' when the score decreases from baseline by x points, and as 'Worse by x points' when the score increases by x points.
    Time Frame Baseline-Week 24

    Outcome Measure Data

    Analysis Population Description
    Intent-to-treat population using Last Observation Carried Forward to address missing data.
    Arm/Group Title ATI-501 400mg BID ATI-501 600mg BID ATI-501 800mg BID Placebo
    Arm/Group Description ATI-501 400mg BID (low dose) - oral administration ATI-501 Low dose ATI-501 600mg BID (mid dose) - oral administration ATI-501 Mid dose ATI-501 800mg BID (high dose) - oral administration ATI-501 high dose Placebo - oral administration
    Measure Participants 23 23 22 19
    Better by 4 points
    0
    0%
    1
    4.3%
    0
    0%
    0
    0%
    Better by 3 points
    2
    8.7%
    1
    4.3%
    1
    4.5%
    0
    0%
    Better by 2 points
    4
    17.4%
    2
    8.7%
    5
    22.7%
    1
    5.3%
    Better by 1 point
    5
    21.7%
    10
    43.5%
    7
    31.8%
    7
    36.8%
    No change
    11
    47.8%
    8
    34.8%
    8
    36.4%
    11
    57.9%
    Worse by 1 point
    1
    4.3%
    1
    4.3%
    1
    4.5%
    0
    0%
    Worse by 2 points
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Worse by 3 points
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Worse by 4 points
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection ATI-501 400mg BID Dosing, Placebo
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.469
    Comments
    Method Wilcoxon (Mann-Whitney)
    Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection ATI-501 600mg BID Dosing, Placebo
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.219
    Comments
    Method Wilcoxon (Mann-Whitney)
    Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection ATI-501 800mg BID Dosing, Placebo
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.196
    Comments
    Method Wilcoxon (Mann-Whitney)
    Comments

    Adverse Events

    Time Frame Double blind period = 24 weeks; Reporting of non-serious AEs started with each subject's first study medication application and continued until the 30 days after the subject's last study visit. Reporting for SAEs started when the subject signed the informed consent document and continued until 30 days after the subject's last visit.
    Adverse Event Reporting Description
    Arm/Group Title ATI-501 400mg BID Dosing ATI-501 600mg BID Dosing ATI-501 800mg BID Dosing Placebo
    Arm/Group Description ATI-501 400mg BID dosing - oral administration ATI-501 400mg BID dosing: ATI-501 oral low dose ATI-501 600mg BID dosing - oral administration ATI-501 600mg BID dosing: ATI-501 oral low dose ATI-501 800mg BID dosing - oral administration ATI-501 800mg BID dosing: ATI-501 high dose for oral administration Placebo: BID - oral administration
    All Cause Mortality
    ATI-501 400mg BID Dosing ATI-501 600mg BID Dosing ATI-501 800mg BID Dosing Placebo
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 0/23 (0%) 0/23 (0%) 0/22 (0%) 0/19 (0%)
    Serious Adverse Events
    ATI-501 400mg BID Dosing ATI-501 600mg BID Dosing ATI-501 800mg BID Dosing Placebo
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 0/23 (0%) 0/23 (0%) 0/22 (0%) 0/19 (0%)
    Other (Not Including Serious) Adverse Events
    ATI-501 400mg BID Dosing ATI-501 600mg BID Dosing ATI-501 800mg BID Dosing Placebo
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 5/23 (21.7%) 2/23 (8.7%) 3/22 (13.6%) 3/19 (15.8%)
    Gastrointestinal disorders
    Nausea 0/23 (0%) 0 1/23 (4.3%) 1 1/22 (4.5%) 1 0/19 (0%) 0
    Abdominal pain 1/23 (4.3%) 1 0/23 (0%) 0 0/22 (0%) 0 0/19 (0%) 0
    Constipation 0/23 (0%) 0 1/23 (4.3%) 1 0/22 (0%) 0 0/19 (0%) 0
    Dyspepsia 0/23 (0%) 0 0/23 (0%) 0 1/22 (4.5%) 1 0/19 (0%) 0
    Feces soft 1/23 (4.3%) 1 0/23 (0%) 0 0/22 (0%) 0 0/19 (0%) 0
    Gastroesophageal reflux disease 1/23 (4.3%) 1 0/23 (0%) 0 0/22 (0%) 0 0/19 (0%) 0
    Vomiting 1/23 (4.3%) 1 0/23 (0%) 0 0/22 (0%) 0 0/19 (0%) 0
    General disorders
    Fatigue 1/23 (4.3%) 1 0/23 (0%) 0 1/22 (4.5%) 1 0/19 (0%) 0
    Infections and infestations
    Folliculitis 0/23 (0%) 0 1/23 (4.3%) 1 0/22 (0%) 0 1/19 (5.3%) 1
    Vulvovaginal mycotic infection 1/23 (4.3%) 1 0/23 (0%) 0 0/22 (0%) 0 0/19 (0%) 0
    Investigations
    Alanine aminotransferase increased 2/23 (8.7%) 2 0/23 (0%) 0 0/22 (0%) 0 0/19 (0%) 0
    Blood creatine phosphokinase increased 1/23 (4.3%) 1 0/23 (0%) 0 0/22 (0%) 0 1/19 (5.3%) 1
    Aspartate aminotransferase increased 1/23 (4.3%) 1 0/23 (0%) 0 0/22 (0%) 0 0/19 (0%) 0
    Nervous system disorders
    Dizziness 1/23 (4.3%) 1 0/23 (0%) 0 0/22 (0%) 0 0/19 (0%) 0
    Headache 0/23 (0%) 0 0/23 (0%) 0 1/22 (4.5%) 1 0/19 (0%) 0
    Paraesthesia 0/23 (0%) 0 0/23 (0%) 0 1/22 (4.5%) 1 0/19 (0%) 0
    Renal and urinary disorders
    Chromaturia 0/23 (0%) 0 0/23 (0%) 0 1/22 (4.5%) 1 0/19 (0%) 0
    Reproductive system and breast disorders
    Adnexa uteri pain 1/23 (4.3%) 1 0/23 (0%) 0 0/22 (0%) 0 0/19 (0%) 0
    Skin and subcutaneous tissue disorders
    Pruritus 1/23 (4.3%) 1 1/23 (4.3%) 1 0/22 (0%) 0 0/19 (0%) 0
    Drug eruption 0/23 (0%) 0 0/23 (0%) 0 0/22 (0%) 0 1/19 (5.3%) 1
    Photosensitivity reaction 0/23 (0%) 0 0/23 (0%) 0 1/22 (4.5%) 1 0/19 (0%) 0
    Vascular disorders
    Hypertension 0/23 (0%) 0 0/23 (0%) 0 0/22 (0%) 0 1/19 (5.3%) 1

    Limitations/Caveats

    [Not Specified]

    More Information

    Certain Agreements

    Principal Investigators are NOT employed by the organization sponsoring the study.

    There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

    Results Point of Contact

    Name/Title Marco Cardillo, Clinical Trial Manager
    Organization Aclaris Therapeutics, Inc.
    Phone 484-540-6299
    Email mcardillo@aclaristx.com
    Responsible Party:
    Aclaris Therapeutics, Inc.
    ClinicalTrials.gov Identifier:
    NCT03594227
    Other Study ID Numbers:
    • ATI-501-AUAT-201
    First Posted:
    Jul 20, 2018
    Last Update Posted:
    Sep 16, 2020
    Last Verified:
    Jun 1, 2020