A Study of the Safety of INCB054707 in Participants With Hidradenitis Suppurativa
Study Details
Study Description
Brief Summary
The purpose of this study is to assess the safety of INCB054707 in men and women with moderate to severe hidradenitis suppurativa (HS).
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
Phase 2 |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Experimental: INCB054707
|
Drug: INCB054707
INCB054707 administered once daily orally with water without regard to food for 8 weeks.
|
Outcome Measures
Primary Outcome Measures
- Number of Participants With Treatment-emergent Adverse Events (TEAEs) [Up to approximately 12 weeks.]
A TEAE is any adverse event (AE) either reported for the first time or worsening of a pre-existing event after first dose of study drug.
Secondary Outcome Measures
- Apparent Oral Clearance of INCB054707(CL/F) [Postdose Day1, week 2 and 6]
To evaluate the systemic exposure to INCB054707.
- Apparent Oral Volume of Distribution of INCB054707(Vc/F) [Postdose Day1, week 2 and 6.]
To evaluate the systemic exposure to INCB054707.
- Absorption Constant of INCB054707 (Ka) [Postdose Day1, week 2 and 6.]
Other population pharmacokinetic (PK) model parameter that the PK model may include to evaluate the systemic exposure to INCB054707.
- Apparent Inter-compartmental Clearance(Q/F) [Postdose Day1, week 2 and 6.]
Other population PK model parameter that the PK model may include to evaluate the systemic exposure to INCB054707.
- Proportion of Participants With a Hidradenitis Suppurativa Clinical Response (HiSCR) at Each Visit [Weeks 1,2,4,6,8 and FollowUp]
An HiSCR is defined as at least 50% reduction in abscess and inflammatory nodule (AN) count with no increase in abscess count and no increase in draining fistula count relative to baseline at each visit.
- Proportion of Participants Achieving an AN Count of 0 to 2 at Each Visit [Weeks 1,2,4,6,8 and FollowUp]
The number and proportion of participants who achieved an Abscess and Inflammatory nodule count of 0 to 2 progressively.
- Mean Change From Baseline in the HS Pain Numeric Rating Scale (NRS) Scores at Each Visit [Weeks 1,2,4,6,8 and FollowUp]
The HS Pain NRS will be completed in a daily diary by participants from screening through EOS. An 11-point scale will be used to assess the worst skin pain due to HS based on a recall period of the last 24 hours. Ratings for the 2 items range from 0 (no skin pain) to 10 (skin pain as bad as you can imagine)
- Mean Change From Baseline in the Modified Sartorius Scale Score [Week 8.]
The Sartorius Scale is used to quantify the severity of HS. Points are awarded for 12 body areas (left and right axillae, left and right sub/inframammary areas, intermammary area, left and right buttocks, left and right inguino-crural folds, perianal area, perineal area, and other). For each area, points are awarded for nodules (2 points for each); abscesses (4 points); fistulas (4 points); scars (1 point); longest distance between two lesions (2-6 points, 0 if no lesions); and if lesions are separated buy normal skin (yes-0 point; no-6 points). The total Sartorius Scale score is the sum of the 12 regional scores. Scale scores range from 0 to infinite, with larger scores representing higher severity of HS.
- Mean Change From Baseline in the Number of Draining Fistulas Count at Each Visit [Up to approximately 12 weeks.]
Draining fistulas are fistulas that drain serous or purulent fluid, either spontaneously or by gentle palpation.
- Proportion of Participants at Each Category of Hurley Stage [Baseline and Week 8.]
The Hurley classification is a static score and was originally designed for selection of the appropriate treatment modality in a certain body region. The assessor determines the Hurley stage in each affected anatomical region. If more than 1 stage is present in the same region, the worst stage in that region is documented. The participant will be assigned an overall Hurley stage classification corresponding to the stage of the worst involved anatomical region. The definition of each Hurley stage is as follows: Stage I : Abscess formation, single or multiple, without sinus tracts and cicatrization (scarring). Stage II : One or more widely separated recurrent abscesses with tract formation and cicatrization (scarring). Stage III : Multiple interconnected tracts and abscesses across the entire area, with diffuse or near diffuse involvement.
- Proportion of Participants With Change From Baseline to Week 8 in Hurley Stage [Week 8.]
The Hurley classification is a static score and was originally designed for selection of the appropriate treatment modality in a certain body region. The assessor determines the Hurley stage in each affected anatomical region. If more than 1 stage is present in the same region, the worst stage in that region is documented. The participant will be assigned an overall Hurley stage classification corresponding to the stage of the worst involved anatomical region. The definition of each Hurley stage is as follows: Stage I : Abscess formation, single or multiple, without sinus tracts and cicatrization (scarring). Stage II : One or more widely separated recurrent abscesses with tract formation and cicatrization (scarring). Stage III : Multiple interconnected tracts and abscesses across the entire area, with diffuse or near diffuse involvement.
- Proportions of Participants in Each HS Patient Global Impression of Change (PGIC) Category [Up to approximately 12 weeks.]
The HS-PGIC consists of 1 self-administered item that assesses change in the severity of skin in the HS area. The participant will answer the following: Since your last visit, your HS is: (1) very much improved, (2) much improved, (3) minimally improved, (4) no change, (5) minimally worse, (6) much worse, or (7) very much worse.
- Proportion of Participants Requiring Rescue Lesional Treatment [Up to approximately 12 weeks.]
Rescue lesional treatment is defined as immediate intervention in the event of an acutely painful lesion.
- Number of Interventions With Rescue Lesional Treatment [Up to approximately 12 weeks.]
Rescue lesional treatment is defined as immediate intervention in the event of an acutely painful lesion.
- Proportion of Participants at Each Scoring Category of the Dermatology Life Quality Index (DLQI) at Each Visit [Up to approximately 12 weeks.]
The DLQI is a questionnaire used to assess the symptoms and the impact of skin problems on quality of life. The DLQI is calculated by summing the score of each question resulting in a maximum of 30 and a minimum of 0. The meaning of DLQI scores can be categorized as follows: 0-1 = No effect at all on patient's life 2-5 = Small effect on patient's life 6-10 = Moderate effect on patient's life 11-20 = Very large effect on patient's life 21-30 = Extremely large effect on patient's life
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Diagnosis of HS (confirmed by a dermatologist) with a disease duration of at least 6 months before screening.
-
Stable course of HS for at least 90 days before screening, as determined by the investigator.
-
HS lesions present in at least 2 distinct anatomic areas, 1 of which must be Hurley Stage II or III at screening and baseline.
-
Total AN count of at least 3 at screening and baseline.
-
Male participants must agree to use contraception per protocol-defined criteria.
Exclusion Criteria:
-
Women of childbearing potential or who are currently pregnant or lactating.
-
Presence of > 20 draining fistulas at screening and baseline.
-
Participants with concurrent conditions or history of other diseases as follows:
-
Any clinically significant medical condition other than HS, as determined by the investigator, that is not adequately controlled with appropriate treatment.
-
Any other active skin disease or condition (eg, bacterial, fungal, or viral infection) that may interfere with the course, severity, or assessments of HS.
-
Active systemic viral infection or any active viral infection that, based on the investigator's clinical assessment, make the participant an unsuitable candidate for the study.
-
Current herpes zoster infection, a history of recurrent herpes zoster, a history of disseminated herpes simplex, or a history of herpes zoster.
-
History of malignancy, including lymphoma and leukemia within 5 years before baseline, other than a successfully treated nonmetastatic cutaneous squamous cell carcinoma, basal cell carcinoma, or localized carcinoma in situ of the cervix.
-
Albinism.
-
Prolonged QT interval corrected for heart rate using Fridericia's formula (QTcF), defined as ≥ 450 msec.
-
Positive test result for tuberculosis (TB) from the QuantiFERON-TB Gold test, or equivalent, at screening (or, if 2 indeterminate tests or not available, then as evaluated by a purified protein derivative test with a result of < 5 mm of induration within 3 months of screening) or a history of active TB.
-
Positive serology test results for HIV, HBsAg, hepatitis B virus (HBV) core antibody, or HCV (HCV antibody with positive HCV-RNA) at screening.
-
Decreased blood cell counts at screening as per protocol-defined parameters.
-
Severely impaired liver function (Child-Pugh Class C) or alanine aminotransferase (ALT) or aspartate aminotransferase (AST) levels ≥ 1.5 × upper limit of normal (ULN).
-
Impaired renal function with serum creatinine > 1.5 mg/dL.
-
Use of prohibited medications per protocol-defined criteria.
-
Known or suspected allergy to INCB054707 or any component of the study drug.
-
Known history of clinically significant drug or alcohol abuse in the last year prior to baseline.
-
Any condition that would, in the investigator's judgment, interfere with full participation in the study, including administration of study drug and attending required study visits; pose a significant risk to the participant; or interfere with interpretation of study data.
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Investigative Site | Los Angeles | California | United States | 90045 |
2 | Investigative Site | Tampa | Florida | United States | 33624 |
3 | Investigative Site | New York | New York | United States | 10065 |
4 | Investigative Site | Hershey | Pennsylvania | United States | 17033 |
Sponsors and Collaborators
- Incyte Corporation
Investigators
- Study Director: Kathleen Butler, MD, Incyte Corporation
Study Documents (Full-Text)
More Information
Publications
None provided.- INCB 54707-202
Study Results
Participant Flow
Recruitment Details | The study was conducted at 4 different sites in US. |
---|---|
Pre-assignment Detail | A total of 10 participants were assigned to treatment with INCB054707. |
Arm/Group Title | INCB054707 |
---|---|
Arm/Group Description | Participants were treated with 15 mg QD of INCB054707 orally. |
Period Title: Overall Study | |
STARTED | 10 |
COMPLETED | 7 |
NOT COMPLETED | 3 |
Baseline Characteristics
Arm/Group Title | INCB054707 |
---|---|
Arm/Group Description | Participants were treated with 15 mg QD of INCB054707 orally. |
Overall Participants | 10 |
Age (Number) [Mean (Standard Deviation) ] | |
Mean (Standard Deviation) [Number] |
40.7
(14.43)
|
Sex: Female, Male (Count of Participants) | |
Female |
3
30%
|
Male |
7
70%
|
Race/Ethnicity, Customized (Count of Participants) | |
Hispanic or Latino |
1
10%
|
Not Hispanic or Latino |
9
90%
|
Race/Ethnicity, Customized (Count of Participants) | |
White/Caucasian |
6
60%
|
Black/African American |
3
30%
|
Other |
1
10%
|
Outcome Measures
Title | Number of Participants With Treatment-emergent Adverse Events (TEAEs) |
---|---|
Description | A TEAE is any adverse event (AE) either reported for the first time or worsening of a pre-existing event after first dose of study drug. |
Time Frame | Up to approximately 12 weeks. |
Outcome Measure Data
Analysis Population Description |
---|
The Full Analysis Set population include all subjects enrolled in the study who received at least 1 dose of INCB054707 |
Arm/Group Title | INCB054707 |
---|---|
Arm/Group Description | Participants were treated with 15 mg QD of INCB054707 orally. |
Measure Participants | 10 |
Number [Participants] |
7
70%
|
Title | Apparent Oral Clearance of INCB054707(CL/F) |
---|---|
Description | To evaluate the systemic exposure to INCB054707. |
Time Frame | Postdose Day1, week 2 and 6 |
Outcome Measure Data
Analysis Population Description |
---|
The Full Analysis Set population include all subjects enrolled in the study who received at least 1 dose of INCB054707 |
Arm/Group Title | INCB054707 |
---|---|
Arm/Group Description | Participants were treated with 15 mg QD of INCB054707 orally. |
Measure Participants | 10 |
Geometric Mean (Geometric Coefficient of Variation) [L/hr] |
5.07
(24.3)
|
Title | Apparent Oral Volume of Distribution of INCB054707(Vc/F) |
---|---|
Description | To evaluate the systemic exposure to INCB054707. |
Time Frame | Postdose Day1, week 2 and 6. |
Outcome Measure Data
Analysis Population Description |
---|
The Full Analysis Set population include all subjects enrolled in the study who received at least 1 dose of INCB054707 |
Arm/Group Title | INCB054707 |
---|---|
Arm/Group Description | Participants were treated with 15 mg QD of INCB054707 orally. |
Measure Participants | 10 |
Geometric Mean (Geometric Coefficient of Variation) [L] |
227
(39.9)
|
Title | Absorption Constant of INCB054707 (Ka) |
---|---|
Description | Other population pharmacokinetic (PK) model parameter that the PK model may include to evaluate the systemic exposure to INCB054707. |
Time Frame | Postdose Day1, week 2 and 6. |
Outcome Measure Data
Analysis Population Description |
---|
The Full Analysis Set population include all subjects enrolled in the study who received at least 1 dose of INCB054707 |
Arm/Group Title | INCB054707 |
---|---|
Arm/Group Description | Participants were treated with 15 mg QD of INCB054707 orally. |
Measure Participants | 10 |
Geometric Mean (Geometric Coefficient of Variation) [1/hr] |
0.257
(15.2)
|
Title | Apparent Inter-compartmental Clearance(Q/F) |
---|---|
Description | Other population PK model parameter that the PK model may include to evaluate the systemic exposure to INCB054707. |
Time Frame | Postdose Day1, week 2 and 6. |
Outcome Measure Data
Analysis Population Description |
---|
The Full Analysis Set population include all subjects enrolled in the study who received at least 1 dose of INCB054707 |
Arm/Group Title | INCB054707 |
---|---|
Arm/Group Description | Participants were treated with 15 mg QD of INCB054707 orally. |
Measure Participants | 10 |
Geometric Mean (Geometric Coefficient of Variation) [L/hr] |
16.2
(13.4)
|
Title | Proportion of Participants With a Hidradenitis Suppurativa Clinical Response (HiSCR) at Each Visit |
---|---|
Description | An HiSCR is defined as at least 50% reduction in abscess and inflammatory nodule (AN) count with no increase in abscess count and no increase in draining fistula count relative to baseline at each visit. |
Time Frame | Weeks 1,2,4,6,8 and FollowUp |
Outcome Measure Data
Analysis Population Description |
---|
The Full Analysis Set population include all subjects enrolled in the study who received at least 1 dose of INCB054707 |
Arm/Group Title | INCB054707 |
---|---|
Arm/Group Description | Participants were treated with 15 mg QD of INCB054707 orally. |
Measure Participants | 10 |
Week 1 |
1
10%
|
Week 2 |
3
30%
|
Week 4 |
3
30%
|
Week 6 |
2
20%
|
Week 8 |
3
30%
|
Follow Up |
4
40%
|
Title | Proportion of Participants Achieving an AN Count of 0 to 2 at Each Visit |
---|---|
Description | The number and proportion of participants who achieved an Abscess and Inflammatory nodule count of 0 to 2 progressively. |
Time Frame | Weeks 1,2,4,6,8 and FollowUp |
Outcome Measure Data
Analysis Population Description |
---|
The Full Analysis Set population include all subjects enrolled in the study who received at least 1 dose of INCB054707 |
Arm/Group Title | INCB054707 |
---|---|
Arm/Group Description | Participants were treated with 15 mg QD of INCB054707 orally. |
Measure Participants | 10 |
Baseline |
0
0%
|
Week 1 |
2
20%
|
Week 2 |
4
40%
|
Week 4 |
4
40%
|
Week 6 |
2
20%
|
Week 8 |
3
30%
|
Follow Up |
4
40%
|
Title | Mean Change From Baseline in the HS Pain Numeric Rating Scale (NRS) Scores at Each Visit |
---|---|
Description | The HS Pain NRS will be completed in a daily diary by participants from screening through EOS. An 11-point scale will be used to assess the worst skin pain due to HS based on a recall period of the last 24 hours. Ratings for the 2 items range from 0 (no skin pain) to 10 (skin pain as bad as you can imagine) |
Time Frame | Weeks 1,2,4,6,8 and FollowUp |
Outcome Measure Data
Analysis Population Description |
---|
The Full Analysis Set population include all subjects enrolled in the study who received at least 1 dose of INCB054707 |
Arm/Group Title | INCB054707 |
---|---|
Arm/Group Description | Participants were treated with 15 mg QD of INCB054707 orally. |
Measure Participants | 10 |
Week 1 |
-1.5
(1.9)
|
Week 2 |
-3.2
(2.9)
|
Week 4 |
-2.6
(2.9)
|
Week 6 |
-3.2
(3.2)
|
Week 8 |
-2.0
(1.8)
|
Follow Up |
-1.8
(1.6)
|
Title | Mean Change From Baseline in the Modified Sartorius Scale Score |
---|---|
Description | The Sartorius Scale is used to quantify the severity of HS. Points are awarded for 12 body areas (left and right axillae, left and right sub/inframammary areas, intermammary area, left and right buttocks, left and right inguino-crural folds, perianal area, perineal area, and other). For each area, points are awarded for nodules (2 points for each); abscesses (4 points); fistulas (4 points); scars (1 point); longest distance between two lesions (2-6 points, 0 if no lesions); and if lesions are separated buy normal skin (yes-0 point; no-6 points). The total Sartorius Scale score is the sum of the 12 regional scores. Scale scores range from 0 to infinite, with larger scores representing higher severity of HS. |
Time Frame | Week 8. |
Outcome Measure Data
Analysis Population Description |
---|
[Not Specified] |
Arm/Group Title | INCB054707 |
---|---|
Arm/Group Description | Participants were treated with 15 mg QD of INCB054707 orally. |
Measure Participants | 10 |
Mean (Standard Deviation) [Units on a Scale] |
-13.6
(21.3)
|
Title | Mean Change From Baseline in the Number of Draining Fistulas Count at Each Visit |
---|---|
Description | Draining fistulas are fistulas that drain serous or purulent fluid, either spontaneously or by gentle palpation. |
Time Frame | Up to approximately 12 weeks. |
Outcome Measure Data
Analysis Population Description |
---|
The Full Analysis Set population include all subjects enrolled in the study who received at least 1 dose of INCB054707 |
Arm/Group Title | INCB054707 |
---|---|
Arm/Group Description | Participants were treated with 15 mg QD of INCB054707 orally. |
Measure Participants | 10 |
Week 1 |
-0.1
(0.6)
|
Week 2 |
0.2
(0.4)
|
Week 4 |
0.6
(1.7)
|
Week 6 |
1.9
(2.9)
|
Week 8 |
0.1
(1.1)
|
Follow Up |
0.7
(2.4)
|
Title | Proportion of Participants at Each Category of Hurley Stage |
---|---|
Description | The Hurley classification is a static score and was originally designed for selection of the appropriate treatment modality in a certain body region. The assessor determines the Hurley stage in each affected anatomical region. If more than 1 stage is present in the same region, the worst stage in that region is documented. The participant will be assigned an overall Hurley stage classification corresponding to the stage of the worst involved anatomical region. The definition of each Hurley stage is as follows: Stage I : Abscess formation, single or multiple, without sinus tracts and cicatrization (scarring). Stage II : One or more widely separated recurrent abscesses with tract formation and cicatrization (scarring). Stage III : Multiple interconnected tracts and abscesses across the entire area, with diffuse or near diffuse involvement. |
Time Frame | Baseline and Week 8. |
Outcome Measure Data
Analysis Population Description |
---|
The Full Analysis Set population include all subjects enrolled in the study who received at least 1 dose of INCB054707 |
Arm/Group Title | INCB054707 |
---|---|
Arm/Group Description | Participants were treated with 15 mg QD of INCB054707 orally. |
Measure Participants | 10 |
Stage I |
0
0%
|
Stage II |
7
70%
|
Stage III |
3
30%
|
No HS |
0
0%
|
Stage I |
0
0%
|
Stage II |
5
50%
|
Stage III |
1
10%
|
No HS |
1
10%
|
Title | Proportion of Participants With Change From Baseline to Week 8 in Hurley Stage |
---|---|
Description | The Hurley classification is a static score and was originally designed for selection of the appropriate treatment modality in a certain body region. The assessor determines the Hurley stage in each affected anatomical region. If more than 1 stage is present in the same region, the worst stage in that region is documented. The participant will be assigned an overall Hurley stage classification corresponding to the stage of the worst involved anatomical region. The definition of each Hurley stage is as follows: Stage I : Abscess formation, single or multiple, without sinus tracts and cicatrization (scarring). Stage II : One or more widely separated recurrent abscesses with tract formation and cicatrization (scarring). Stage III : Multiple interconnected tracts and abscesses across the entire area, with diffuse or near diffuse involvement. |
Time Frame | Week 8. |
Outcome Measure Data
Analysis Population Description |
---|
The Full Analysis Set population include all subjects enrolled in the study who received at least 1 dose of INCB054707 |
Arm/Group Title | INCB054707 |
---|---|
Arm/Group Description | Participants were treated with 15 mg QD of INCB054707 orally. |
Measure Participants | 10 |
No HS |
0
0%
|
Stage I |
0
0%
|
Stage II |
7
70%
|
Stage III |
3
30%
|
No HS |
1
10%
|
Stage I |
0
0%
|
Stage II |
5
50%
|
Stage III |
1
10%
|
Title | Proportions of Participants in Each HS Patient Global Impression of Change (PGIC) Category |
---|---|
Description | The HS-PGIC consists of 1 self-administered item that assesses change in the severity of skin in the HS area. The participant will answer the following: Since your last visit, your HS is: (1) very much improved, (2) much improved, (3) minimally improved, (4) no change, (5) minimally worse, (6) much worse, or (7) very much worse. |
Time Frame | Up to approximately 12 weeks. |
Outcome Measure Data
Analysis Population Description |
---|
The Full Analysis Set population include all subjects enrolled in the study who received at least 1 dose of INCB054707 |
Arm/Group Title | INCB054707 |
---|---|
Arm/Group Description | Participants were treated with 15 mg QD of INCB054707 orally. |
Measure Participants | 10 |
1 |
0
0%
|
2 |
0
0%
|
3 |
3
30%
|
4 |
5
50%
|
5 |
2
20%
|
6 |
0
0%
|
7 |
0
0%
|
1 |
0
0%
|
2 |
1
10%
|
3 |
5
50%
|
4 |
2
20%
|
5 |
1
10%
|
6 |
0
0%
|
7 |
0
0%
|
1 |
1
10%
|
2 |
1
10%
|
3 |
0
0%
|
4 |
4
40%
|
5 |
3
30%
|
6 |
0
0%
|
7 |
0
0%
|
1 |
1
10%
|
2 |
1
10%
|
3 |
2
20%
|
4 |
2
20%
|
5 |
1
10%
|
6 |
0
0%
|
7 |
0
0%
|
1 |
0
0%
|
2 |
1
10%
|
3 |
2
20%
|
4 |
3
30%
|
5 |
1
10%
|
6 |
0
0%
|
7 |
0
0%
|
1 |
0
0%
|
2 |
1
10%
|
3 |
2
20%
|
4 |
3
30%
|
5 |
0
0%
|
6 |
0
0%
|
7 |
0
0%
|
Title | Proportion of Participants Requiring Rescue Lesional Treatment |
---|---|
Description | Rescue lesional treatment is defined as immediate intervention in the event of an acutely painful lesion. |
Time Frame | Up to approximately 12 weeks. |
Outcome Measure Data
Analysis Population Description |
---|
The Full Analysis Set population include all subjects enrolled in the study who received at least 1 dose of INCB054707 |
Arm/Group Title | INCB054707 |
---|---|
Arm/Group Description | Participants were treated with 15 mg QD of INCB054707 orally. |
Measure Participants | 10 |
Intervention Required -Yes |
1
10%
|
Intervention Required -No |
9
90%
|
Intervention Required -Yes |
0
0%
|
Intervention Required -No |
9
90%
|
Intervention Required -Yes |
0
0%
|
Intervention Required -No |
9
90%
|
Intervention Required -Yes |
0
0%
|
Intervention Required -No |
7
70%
|
Intervention Required -Yes |
1
10%
|
Intervention Required -No |
6
60%
|
Intervention Required -Yes |
0
0%
|
Intervention Required -No |
7
70%
|
Title | Number of Interventions With Rescue Lesional Treatment |
---|---|
Description | Rescue lesional treatment is defined as immediate intervention in the event of an acutely painful lesion. |
Time Frame | Up to approximately 12 weeks. |
Outcome Measure Data
Analysis Population Description |
---|
The Full Analysis Set population include all subjects enrolled in the study who received at least 1 dose of INCB054707 |
Arm/Group Title | INCB054707 |
---|---|
Arm/Group Description | Participants were treated with 15 mg QD of INCB054707 orally. |
Measure Participants | 10 |
Week 1 |
0.1
(0.32)
|
Week 2 |
0
(0.00)
|
Week 4 |
0
(0.00)
|
Week 6 |
0
(0.00)
|
Week 8 |
0.1
(0.38)
|
Follow Up |
0
(0.00)
|
Title | Proportion of Participants at Each Scoring Category of the Dermatology Life Quality Index (DLQI) at Each Visit |
---|---|
Description | The DLQI is a questionnaire used to assess the symptoms and the impact of skin problems on quality of life. The DLQI is calculated by summing the score of each question resulting in a maximum of 30 and a minimum of 0. The meaning of DLQI scores can be categorized as follows: 0-1 = No effect at all on patient's life 2-5 = Small effect on patient's life 6-10 = Moderate effect on patient's life 11-20 = Very large effect on patient's life 21-30 = Extremely large effect on patient's life |
Time Frame | Up to approximately 12 weeks. |
Outcome Measure Data
Analysis Population Description |
---|
The Full Analysis Set population include all subjects enrolled in the study who received at least 1 dose of INCB054707 |
Arm/Group Title | INCB054707 |
---|---|
Arm/Group Description | Participants were treated with 15 mg QD of INCB054707 orally. |
Measure Participants | 10 |
0-1 |
0
0%
|
2-5 |
1
10%
|
6-10 |
3
30%
|
11-20 |
2
20%
|
21-30 |
4
40%
|
0-1 |
0
0%
|
2-5 |
2
20%
|
6-10 |
2
20%
|
11-20 |
3
30%
|
21-30 |
3
30%
|
0-1 |
0
0%
|
2-5 |
5
50%
|
6-10 |
1
10%
|
11-20 |
1
10%
|
21-30 |
2
20%
|
0-1 |
2
20%
|
2-5 |
1
10%
|
6-10 |
2
20%
|
11-20 |
3
30%
|
21-30 |
1
10%
|
0-1 |
1
10%
|
2-5 |
1
10%
|
6-10 |
2
20%
|
11-20 |
1
10%
|
21-30 |
2
20%
|
0-1 |
0
0%
|
2-5 |
3
30%
|
6-10 |
1
10%
|
11-20 |
1
10%
|
21-30 |
2
20%
|
0-1 |
0
0%
|
2-5 |
3
30%
|
6-10 |
0
0%
|
11-20 |
2
20%
|
21-30 |
2
20%
|
Adverse Events
Time Frame | Up to approximately 12 weeks | |
---|---|---|
Adverse Event Reporting Description | ||
Arm/Group Title | INCB054707 | |
Arm/Group Description | Participants were treated with 15 mg QD of INCB054707 orally. | |
All Cause Mortality |
||
INCB054707 | ||
Affected / at Risk (%) | # Events | |
Total | 0/10 (0%) | |
Serious Adverse Events |
||
INCB054707 | ||
Affected / at Risk (%) | # Events | |
Total | 0/10 (0%) | |
Other (Not Including Serious) Adverse Events |
||
INCB054707 | ||
Affected / at Risk (%) | # Events | |
Total | 7/10 (70%) | |
Gastrointestinal disorders | ||
Nausea | 1/10 (10%) | |
Infections and infestations | ||
Upper respiratory tract infection | 3/10 (30%) | |
Musculoskeletal and connective tissue disorders | ||
Fibromyalgia | 1/10 (10%) | |
Nervous system disorders | ||
Headache | 1/10 (10%) | |
Psychiatric disorders | ||
Anxiety | 1/10 (10%) | |
Skin and subcutaneous tissue disorders | ||
Night sweats | 1/10 (10%) | |
Rash | 1/10 (10%) |
Limitations/Caveats
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
Clinical Study Agreement
Results Point of Contact
Name/Title | Incyte Corporation Call Center, Study Director |
---|---|
Organization | Incyte Corporation |
Phone | 1-855-463-3463 |
medinfo@incyte.com |
- INCB 54707-202