A Study of the Safety of INCB054707 in Participants With Hidradenitis Suppurativa

Sponsor
Incyte Corporation (Industry)
Overall Status
Completed
CT.gov ID
NCT03569371
Collaborator
(none)
10
4
1
9.2
2.5
0.3

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

Study Type:
Interventional
Actual Enrollment :
10 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Phase 2, Open-Label, Single-Arm Study of the Safety of INCB054707 in Participants With Hidradenitis Suppurativa
Actual Study Start Date :
Jul 17, 2018
Actual Primary Completion Date :
Apr 22, 2019
Actual Study Completion Date :
Apr 22, 2019

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

  1. 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

  1. Apparent Oral Clearance of INCB054707(CL/F) [Postdose Day1, week 2 and 6]

    To evaluate the systemic exposure to INCB054707.

  2. Apparent Oral Volume of Distribution of INCB054707(Vc/F) [Postdose Day1, week 2 and 6.]

    To evaluate the systemic exposure to INCB054707.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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)

  8. 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.

  9. 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.

  10. 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.

  11. 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.

  12. 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.

  13. 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.

  14. 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.

  15. 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

Ages Eligible for Study:
18 Years to 75 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.
Responsible Party:
Incyte Corporation
ClinicalTrials.gov Identifier:
NCT03569371
Other Study ID Numbers:
  • INCB 54707-202
First Posted:
Jun 26, 2018
Last Update Posted:
Nov 3, 2021
Last Verified:
Oct 1, 2021
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
Keywords provided by Incyte Corporation
Additional relevant MeSH terms:

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

1. Primary Outcome
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%
2. Secondary Outcome
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)
3. Secondary Outcome
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)
4. Secondary Outcome
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)
5. Secondary Outcome
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)
6. Secondary Outcome
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%
7. Secondary Outcome
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%
8. Secondary Outcome
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)
9. Secondary Outcome
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)
10. Secondary Outcome
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)
11. Secondary Outcome
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%
12. Secondary Outcome
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%
13. Secondary Outcome
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%
14. Secondary Outcome
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%
15. Secondary Outcome
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)
16. Secondary Outcome
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

[Not Specified]

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
Email medinfo@incyte.com
Responsible Party:
Incyte Corporation
ClinicalTrials.gov Identifier:
NCT03569371
Other Study ID Numbers:
  • INCB 54707-202
First Posted:
Jun 26, 2018
Last Update Posted:
Nov 3, 2021
Last Verified:
Oct 1, 2021