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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03569371
Recruitment Status : Completed
First Posted : June 26, 2018
Results First Posted : May 20, 2020
Last Update Posted : September 26, 2022
Sponsor:
Information provided by (Responsible Party):
Incyte Corporation

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Hidradenitis Suppurativa
Intervention Drug: INCB054707
Enrollment 10
Recruitment Details The study was conducted at 4 different sites in US.
Pre-assignment Details A total of 10 participants were assigned to treatment with INCB054707.
Arm/Group Title INCB054707
Hide Arm/Group Description Participants were treated with 15 mg QD of INCB054707 orally.
Period Title: Overall Study
Started 10
Completed 7
Not Completed 3
Reason Not Completed
Lack of Efficacy             1
Lost to Follow-up             1
Adverse Event             1
Arm/Group Title INCB054707
Hide Arm/Group Description Participants were treated with 15 mg QD of INCB054707 orally.
Overall Number of Baseline Participants 10
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Number
Number Analyzed 10 participants
40.7  (14.43)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants
Female
3
  30.0%
Male
7
  70.0%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
 Number Analyzed 10 participants
Hispanic or Latino
1
  10.0%
Not Hispanic or Latino
9
  90.0%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
 Number Analyzed 10 participants
White/Caucasian
6
  60.0%
Black/African American
3
  30.0%
Other
1
  10.0%
1.Primary Outcome
Title Number of Participants With Treatment-emergent Adverse Events (TEAEs)
Hide 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.
Hide Outcome Measure Data
Hide 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
Hide Arm/Group Description:
Participants were treated with 15 mg QD of INCB054707 orally.
Overall Number of Participants Analyzed 10
Measure Type: Number
Unit of Measure: Participants
7
2.Secondary Outcome
Title Apparent Oral Clearance of INCB054707(CL/F)
Hide Description To evaluate the systemic exposure to INCB054707.
Time Frame Postdose Day1, week 2 and 6
Hide Outcome Measure Data
Hide 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
Hide Arm/Group Description:
Participants were treated with 15 mg QD of INCB054707 orally.
Overall Number of Participants Analyzed 10
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: L/hr
5.07
(24.3%)
3.Secondary Outcome
Title Apparent Oral Volume of Distribution of INCB054707(Vc/F)
Hide Description To evaluate the systemic exposure to INCB054707.
Time Frame Postdose Day1, week 2 and 6.
Hide Outcome Measure Data
Hide 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
Hide Arm/Group Description:
Participants were treated with 15 mg QD of INCB054707 orally.
Overall Number of Participants Analyzed 10
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: L
227
(39.9%)
4.Secondary Outcome
Title Absorption Constant of INCB054707 (Ka)
Hide 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.
Hide Outcome Measure Data
Hide 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
Hide Arm/Group Description:
Participants were treated with 15 mg QD of INCB054707 orally.
Overall Number of Participants Analyzed 10
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: 1/hr
0.257
(15.2%)
5.Secondary Outcome
Title Apparent Inter-compartmental Clearance(Q/F)
Hide 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.
Hide Outcome Measure Data
Hide 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
Hide Arm/Group Description:
Participants were treated with 15 mg QD of INCB054707 orally.
Overall Number of Participants Analyzed 10
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: L/hr
16.2
(13.4%)
6.Secondary Outcome
Title Proportion of Participants With a Hidradenitis Suppurativa Clinical Response (HiSCR) at Each Visit
Hide 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
Hide Outcome Measure Data
Hide 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
Hide Arm/Group Description:
Participants were treated with 15 mg QD of INCB054707 orally.
Overall Number of Participants Analyzed 10
Measure Type: Count of Participants
Unit of Measure: Participants
Week 1 Number Analyzed 9 participants
1
  11.1%
Week 2 Number Analyzed 9 participants
3
  33.3%
Week 4 Number Analyzed 9 participants
3
  33.3%
Week 6 Number Analyzed 7 participants
2
  28.6%
Week 8 Number Analyzed 7 participants
3
  42.9%
Follow Up Number Analyzed 7 participants
4
  57.1%
7.Secondary Outcome
Title Proportion of Participants Achieving an AN Count of 0 to 2 at Each Visit
Hide 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
Hide Outcome Measure Data
Hide 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
Hide Arm/Group Description:
Participants were treated with 15 mg QD of INCB054707 orally.
Overall Number of Participants Analyzed 10
Measure Type: Count of Participants
Unit of Measure: Participants
Baseline Number Analyzed 10 participants
0
   0.0%
Week 1 Number Analyzed 9 participants
2
  22.2%
Week 2 Number Analyzed 9 participants
4
  44.4%
Week 4 Number Analyzed 9 participants
4
  44.4%
Week 6 Number Analyzed 7 participants
2
  28.6%
Week 8 Number Analyzed 7 participants
3
  42.9%
Follow Up Number Analyzed 7 participants
4
  57.1%
8.Secondary Outcome
Title Mean Change From Baseline in the HS Pain Numeric Rating Scale (NRS) Scores at Each Visit
Hide 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
Hide Outcome Measure Data
Hide 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
Hide Arm/Group Description:
Participants were treated with 15 mg QD of INCB054707 orally.
Overall Number of Participants Analyzed 10
Mean (Standard Deviation)
Unit of Measure: Units on a Scale
Week 1 Number Analyzed 10 participants
-1.5  (1.9)
Week 2 Number Analyzed 9 participants
-3.2  (2.9)
Week 4 Number Analyzed 9 participants
-2.6  (2.9)
Week 6 Number Analyzed 7 participants
-3.2  (3.2)
Week 8 Number Analyzed 7 participants
-2.0  (1.8)
Follow Up Number Analyzed 6 participants
-1.8  (1.6)
9.Secondary Outcome
Title Mean Change From Baseline in the Modified Sartorius Scale Score
Hide 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.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title INCB054707
Hide Arm/Group Description:
Participants were treated with 15 mg QD of INCB054707 orally.
Overall Number of Participants Analyzed 10
Mean (Standard Deviation)
Unit of Measure: 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
Hide Description Draining fistulas are fistulas that drain serous or purulent fluid, either spontaneously or by gentle palpation.
Time Frame Up to approximately 12 weeks.
Hide Outcome Measure Data
Hide 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
Hide Arm/Group Description:
Participants were treated with 15 mg QD of INCB054707 orally.
Overall Number of Participants Analyzed 10
Mean (Standard Deviation)
Unit of Measure: Number of Fistulas
Week 1 Number Analyzed 9 participants
-0.1  (0.6)
Week 2 Number Analyzed 9 participants
0.2  (0.4)
Week 4 Number Analyzed 9 participants
0.6  (1.7)
Week 6 Number Analyzed 7 participants
1.9  (2.9)
Week 8 Number Analyzed 7 participants
0.1  (1.1)
Follow Up Number Analyzed 7 participants
0.7  (2.4)
11.Secondary Outcome
Title Proportion of Participants at Each Category of Hurley Stage
Hide 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.
Hide Outcome Measure Data
Hide 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
Hide Arm/Group Description:
Participants were treated with 15 mg QD of INCB054707 orally.
Overall Number of Participants Analyzed 10
Measure Type: Count of Participants
Unit of Measure: Participants
Baseline Number Analyzed 10 participants
Stage I
0
   0.0%
Stage II
7
  70.0%
Stage III
3
  30.0%
No HS
0
   0.0%
Week 8 Number Analyzed 7 participants
Stage I
0
   0.0%
Stage II
5
  71.4%
Stage III
1
  14.3%
No HS
1
  14.3%
12.Secondary Outcome
Title Proportion of Participants With Change From Baseline to Week 8 in Hurley Stage
Hide 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.
Hide Outcome Measure Data
Hide 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
Hide Arm/Group Description:
Participants were treated with 15 mg QD of INCB054707 orally.
Overall Number of Participants Analyzed 10
Measure Type: Count of Participants
Unit of Measure: Participants
Baseline Number Analyzed 10 participants
No HS
0
   0.0%
Stage I
0
   0.0%
Stage II
7
  70.0%
Stage III
3
  30.0%
Week 8 Number Analyzed 7 participants
No HS
1
  14.3%
Stage I
0
   0.0%
Stage II
5
  71.4%
Stage III
1
  14.3%
13.Secondary Outcome
Title Proportions of Participants in Each HS Patient Global Impression of Change (PGIC) Category
Hide 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.
Hide Outcome Measure Data
Hide 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
Hide Arm/Group Description:
Participants were treated with 15 mg QD of INCB054707 orally.
Overall Number of Participants Analyzed 10
Measure Type: Count of Participants
Unit of Measure: Participants
Week 1 Number Analyzed 10 participants
1
0
   0.0%
2
0
   0.0%
3
3
  30.0%
4
5
  50.0%
5
2
  20.0%
6
0
   0.0%
7
0
   0.0%
Week 2 Number Analyzed 9 participants
1
0
   0.0%
2
1
  11.1%
3
5
  55.6%
4
2
  22.2%
5
1
  11.1%
6
0
   0.0%
7
0
   0.0%
Week 4 Number Analyzed 9 participants
1
1
  11.1%
2
1
  11.1%
3
0
   0.0%
4
4
  44.4%
5
3
  33.3%
6
0
   0.0%
7
0
   0.0%
Week 6 Number Analyzed 7 participants
1
1
  14.3%
2
1
  14.3%
3
2
  28.6%
4
2
  28.6%
5
1
  14.3%
6
0
   0.0%
7
0
   0.0%
Week 8 Number Analyzed 7 participants
1
0
   0.0%
2
1
  14.3%
3
2
  28.6%
4
3
  42.9%
5
1
  14.3%
6
0
   0.0%
7
0
   0.0%
Follow Up Number Analyzed 6 participants
1
0
   0.0%
2
1
  16.7%
3
2
  33.3%
4
3
  50.0%
5
0
   0.0%
6
0
   0.0%
7
0
   0.0%
14.Secondary Outcome
Title Proportion of Participants Requiring Rescue Lesional Treatment
Hide Description Rescue lesional treatment is defined as immediate intervention in the event of an acutely painful lesion.
Time Frame Up to approximately 12 weeks.
Hide Outcome Measure Data
Hide 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
Hide Arm/Group Description:
Participants were treated with 15 mg QD of INCB054707 orally.
Overall Number of Participants Analyzed 10
Measure Type: Count of Participants
Unit of Measure: Participants
Week 1 Number Analyzed 10 participants
Intervention Required -Yes
1
  10.0%
Intervention Required -No
9
  90.0%
Week 2 Number Analyzed 9 participants
Intervention Required -Yes
0
   0.0%
Intervention Required -No
9
 100.0%
Week 4 Number Analyzed 9 participants
Intervention Required -Yes
0
   0.0%
Intervention Required -No
9
 100.0%
Week 6 Number Analyzed 7 participants
Intervention Required -Yes
0
   0.0%
Intervention Required -No
7
 100.0%
Week 8 Number Analyzed 7 participants
Intervention Required -Yes
1
  14.3%
Intervention Required -No
6
  85.7%
Follow Up Number Analyzed 7 participants
Intervention Required -Yes
0
   0.0%
Intervention Required -No
7
 100.0%
15.Secondary Outcome
Title Number of Interventions With Rescue Lesional Treatment
Hide Description Rescue lesional treatment is defined as immediate intervention in the event of an acutely painful lesion.
Time Frame Up to approximately 12 weeks.
Hide Outcome Measure Data
Hide 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
Hide Arm/Group Description:
Participants were treated with 15 mg QD of INCB054707 orally.
Overall Number of Participants Analyzed 10
Mean (Standard Deviation)
Unit of Measure: Interventions
Week 1 Number Analyzed 10 participants
0.1  (0.32)
Week 2 Number Analyzed 9 participants
0  (0.00)
Week 4 Number Analyzed 9 participants
0  (0.00)
Week 6 Number Analyzed 7 participants
0  (0.00)
Week 8 Number Analyzed 7 participants
0.1  (0.38)
Follow Up Number Analyzed 7 participants
0  (0.00)
16.Secondary Outcome
Title Proportion of Participants at Each Scoring Category of the Dermatology Life Quality Index (DLQI) at Each Visit
Hide 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.
Hide Outcome Measure Data
Hide 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
Hide Arm/Group Description:
Participants were treated with 15 mg QD of INCB054707 orally.
Overall Number of Participants Analyzed 10
Measure Type: Count of Participants
Unit of Measure: Participants
Baseline Number Analyzed 10 participants
0-1
0
   0.0%
2-5
1
  10.0%
6-10
3
  30.0%
11-20
2
  20.0%
21-30
4
  40.0%
Week 1 Number Analyzed 10 participants
0-1
0
   0.0%
2-5
2
  20.0%
6-10
2
  20.0%
11-20
3
  30.0%
21-30
3
  30.0%
Week 2 Number Analyzed 9 participants
0-1
0
   0.0%
2-5
5
  55.6%
6-10
1
  11.1%
11-20
1
  11.1%
21-30
2
  22.2%
Week 4 Number Analyzed 9 participants
0-1
2
  22.2%
2-5
1
  11.1%
6-10
2
  22.2%
11-20
3
  33.3%
21-30
1
  11.1%
Week 6 Number Analyzed 7 participants
0-1
1
  14.3%
2-5
1
  14.3%
6-10
2
  28.6%
11-20
1
  14.3%
21-30
2
  28.6%
Week 8 Number Analyzed 7 participants
0-1
0
   0.0%
2-5
3
  42.9%
6-10
1
  14.3%
11-20
1
  14.3%
21-30
2
  28.6%
Follow Up Number Analyzed 7 participants
0-1
0
   0.0%
2-5
3
  42.9%
6-10
0
   0.0%
11-20
2
  28.6%
21-30
2
  28.6%
Time Frame Up to approximately 12 weeks
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title INCB054707
Hide Arm/Group Description Participants were treated with 15 mg QD of INCB054707 orally.
All-Cause Mortality
INCB054707
Affected / at Risk (%)
Total   0/10 (0.00%) 
Hide Serious Adverse Events
INCB054707
Affected / at Risk (%)
Total   0/10 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
INCB054707
Affected / at Risk (%)
Total   7/10 (70.00%) 
Gastrointestinal disorders   
Nausea †  1/10 (10.00%) 
Infections and infestations   
Upper respiratory tract infection †  3/10 (30.00%) 
Musculoskeletal and connective tissue disorders   
Fibromyalgia †  1/10 (10.00%) 
Nervous system disorders   
Headache †  1/10 (10.00%) 
Psychiatric disorders   
Anxiety †  1/10 (10.00%) 
Skin and subcutaneous tissue disorders   
Night sweats †  1/10 (10.00%) 
Rash †  1/10 (10.00%) 
†
Indicates events were collected by systematic assessment
[Not Specified]
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS 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.
Clinical Study Agreement
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Incyte Corporation Call Center, Study Director
Organization: Incyte Corporation
Phone: 1-855-463-3463
EMail: medinfo@incyte.com
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Incyte Corporation
ClinicalTrials.gov Identifier: NCT03569371    
Other Study ID Numbers: INCB 54707-202
First Submitted: May 24, 2018
First Posted: June 26, 2018
Results First Submitted: April 22, 2020
Results First Posted: May 20, 2020
Last Update Posted: September 26, 2022