A Placebo-Controlled Study of the Safety of INCB054707 in Participants With Hidradenitis Suppurativa
Sponsor
Incyte Corporation (Industry)
Overall Status
Completed
CT.gov ID
NCT03607487
Collaborator
(none)
35
13
3
9.9
2.7
0.3
Study Details
Study Description
Brief Summary
The purpose of this study is to evaluate the safety of INCB054707 over an 8-week treatment period in men and women with moderate to severe hidradenitis suppurativa.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
Study Design
Study Type:
Interventional
Actual Enrollment
:
35 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
A Phase 2, Dose-Escalation, Placebo-Controlled Study of the Safety of INCB054707 in Participants With Hidradenitis Suppurativa
Actual Study Start Date
:
Oct 15, 2018
Actual Primary Completion Date
:
Aug 13, 2019
Actual Study Completion Date
:
Aug 13, 2019
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Cohort 1 INCB054707 at the Cohort 1 dose or placebo. |
Drug: INCB054707
INCB054707 tablet administered orally once daily at the protocol-defined dose.
Drug: Placebo
Placebo tablet administered orally once daily.
|
| Experimental: Cohort 2 INCB054707 at the Cohort 2 dose or placebo. |
Drug: INCB054707
INCB054707 tablet administered orally once daily at the protocol-defined dose.
Drug: Placebo
Placebo tablet administered orally once daily.
|
| Experimental: Cohort 3 INCB054707 at the Cohort 3 dose or placebo. |
Drug: INCB054707
INCB054707 tablet administered orally once daily at the protocol-defined dose.
Drug: Placebo
Placebo tablet administered orally once daily.
|
Outcome Measures
Primary Outcome Measures
- Number of Treatment-emergent Adverse Events (TEAEs) [Up to 12 weeks]
TEAE is defined as any adverse event either reported for the first time or worsening of a pre-existing event after first dose of study drug. Grading was performed using guidance from the CTCAE v 4.03. A grade 3 and above would constitute as "severe".
Secondary Outcome Measures
- Apparent Oral Clearance of INCB054707 [Predose Day 1, Week 4, and 8, Postdose Day1, week 2,4,6, and 8]
To determine the systemic exposure to INCB054707. Dependent upon the final compartmental model describing INCB054707.
- Apparent Oral Volume of Distribution of INCB054707 [Predose Day 1, Week 4, and 8, Postdose Day1, week 2,4,6, and 8]
To determine the systemic exposure to INCB054707. Dependent upon the final compartmental model describing INCB054707.
- Proportion of Participants Achieving a Hidradenitis Suppurativa Clinical Response (HiSCR) at Each Visit [Weeks 1, 2, 4, 6, 8, Early Termination and Follow-up (Up to 3 months)]
HiSCR 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.
- Proportion of Participants Achieving an AN Count of 0 to 2 at Each Visit [Baseline,Weeks 1, 2, 4, 6, 8, Early Termination and Follow-up (Up to 3 months)]
AN defined as abscess and inflammatory nodule count.
- Mean Change From Baseline in the Hidradenitis Suppurativa Pain Numeric Rating Scale (HS Pain NRS) Scores at Each Visit [Baseline,Weeks 1, 2, 4, 6, 8, Early Termination and Follow-up (Up to 3 months)]
An 11-point scale used to assess the worst skin pain and the average skin pain due to HS. Skin pain ranges 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 [From baseline up to 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. [Baseline,Weeks 1, 2, 4, 6, 8 and Follow-up (Up to 3 months)]
Defined as 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.
- Proportions of Participants in Each HS Patient Global Impression of Change (PGIC) Category During the Treatment Period [Up to 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.
- Actual Measurements in HS-PGIC at Each Visit [Up to 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 With Change From Baseline 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.
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 Hurley Stage III at screening.
-
Total AN count of at least 3 at screening and baseline.
-
Willingness to avoid pregnancy or fathering children.
Exclusion Criteria:
-
Women who are currently pregnant or lactating.
-
Presence of > 20 draining fistulas at screening and baseline.
-
Participants with protocol-defined concurrent conditions or history of other diseases.
-
Prolonged QT interval corrected for heart rate using Fridericia's formula (QTcF), defined as ≥ 450 msec.
-
Positive test result for tuberculosis from the QuantiFERON-TB Gold test, or T-SPOT.TB test at screening.
-
A history of active tuberculosis (treated or untreated) or a history of untreated latent tuberculosis.
-
Positive serology test results for HIV, hepatitis B surface antigen, hepatitis B virus core antibody, or hepatitis C virus (HCV antibody with positive HCV-RNA) at screening.
-
Decreased blood cell counts at screening per protocol-defined criteria.
-
Severely impaired liver function (Child-Pugh Class C) or alanine aminotransferase or aspartate aminotransferase levels ≥ 1.5 × upper limit of normal at screening.
-
Impaired renal function with serum creatinine > 1.5 mg/dL at screening.
-
Use of protocol-prohibited medications.
-
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 before baseline.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Investigative Site | Winnipeg | Manitoba | Canada | R3M 3Z4 |
| 2 | Investigative Site | Fredericton | New Brunswick | Canada | E3B 1G9 |
| 3 | Investigative Site | Barrie | Ontario | Canada | L4M 7G1 |
| 4 | Investigative Site | London | Ontario | Canada | N6H 5L5 |
| 5 | Investigative Site 009 | Markham | Ontario | Canada | L3P 1X2 |
| 6 | Investigative Site 008 | Richmond Hill | Ontario | Canada | L4C 9M7 |
| 7 | Investigative Site 007 | Windsor | Ontario | Canada | N8W 5L7 |
| 8 | Investigative Site | Drummondville | Quebec | Canada | J2B 5L4 |
| 9 | Investigative Site | St-Jerome | Quebec | Canada | J7Z 7E2 |
| 10 | Investigative Site | Aarhus | Denmark | 8200 | |
| 11 | Investigative Site | Roskilde | Denmark | 4000 | |
| 12 | Investigative Site | Bochum | Noth Rhine-Westphalia | Germany | 44791 |
| 13 | Investigative Site | Lübeck | Schleswig-Holstein | Germany | 23538 |
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:
NCT03607487
Other Study ID Numbers:
- INCB 54707-203
First Posted:
Jul 31, 2018
Last Update Posted:
Mar 2, 2022
Last Verified:
Feb 1, 2022
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
Product Manufactured in and Exported from the U.S.:
Yes
Keywords provided by Incyte Corporation
Additional relevant MeSH terms:
Study Results
Participant Flow
| Recruitment Details | The study was conducted at 9 different sites in Canada, 2 different sites in Germany and 1 site in Denmark |
|---|---|
| Pre-assignment Detail | A total of 43 participants were screened for enrollment in the study, 8 did not meet the eligibility criteria. A total of 35 participants were randomized to one of the treatment groups. |
| Arm/Group Title | Placebo | INCB054707 at 30 mg | INCB054707 at 60 mg | INCB054707 at 90 mg |
|---|---|---|---|---|
| Arm/Group Description | Placebo was administered QD over an 8 week treatment period. | INCB054707 was administered at 30 mg QD over an 8 week treatment period. | INCB054707 was administered at 60 mg QD over an 8 week treatment period. | INCB054707 was administered at 90 mg QD over an 8 week treatment period. |
| Period Title: Overall Study | ||||
| STARTED | 9 | 9 | 9 | 8 |
| COMPLETED | 7 | 9 | 9 | 7 |
| NOT COMPLETED | 2 | 0 | 0 | 1 |
Baseline Characteristics
| Arm/Group Title | Placebo | INCB054707 at 30 mg | INCB054707 at 60 mg | INCB054707 at 90 mg | Total |
|---|---|---|---|---|---|
| Arm/Group Description | Placebo was administered QD over an 8 week treatment period. | INCB054707 was administered at 30 mg QD over an 8 week treatment period. | INCB054707 was administered at 60 mg QD over an 8 week treatment period. | INCB054707 was administered at 90 mg QD over an 8 week treatment period. | Total of all reporting groups |
| Overall Participants | 9 | 9 | 9 | 8 | 35 |
| Age (years) [Mean (Standard Deviation) ] | |||||
| Mean (Standard Deviation) [years] |
40.3
(16.70)
|
41.0
(11.53)
|
42.2
(11.96)
|
42.8
(14.62)
|
41.5
(13.25)
|
| Sex: Female, Male (Count of Participants) | |||||
| Female |
8
88.9%
|
7
77.8%
|
8
88.9%
|
5
62.5%
|
28
80%
|
| Male |
1
11.1%
|
2
22.2%
|
1
11.1%
|
3
37.5%
|
7
20%
|
| Race/Ethnicity, Customized (Count of Participants) | |||||
| White/Caucasian |
8
88.9%
|
7
77.8%
|
9
100%
|
7
87.5%
|
31
88.6%
|
| Black/African-American |
0
0%
|
0
0%
|
0
0%
|
1
12.5%
|
1
2.9%
|
| American-Indian/Alaska Native |
0
0%
|
2
22.2%
|
0
0%
|
0
0%
|
2
5.7%
|
| Other |
1
11.1%
|
0
0%
|
0
0%
|
0
0%
|
1
2.9%
|
| Race/Ethnicity, Customized (Count of Participants) | |||||
| Hispanic or Latino |
0
0%
|
1
11.1%
|
0
0%
|
0
0%
|
1
2.9%
|
| Not Hispanic or Latino |
9
100%
|
7
77.8%
|
9
100%
|
8
100%
|
33
94.3%
|
| Not Reported |
0
0%
|
1
11.1%
|
0
0%
|
0
0%
|
1
2.9%
|
Outcome Measures
| Title | Apparent Oral Clearance of INCB054707 |
|---|---|
| Description | To determine the systemic exposure to INCB054707. Dependent upon the final compartmental model describing INCB054707. |
| Time Frame | Predose Day 1, Week 4, and 8, Postdose Day1, week 2,4,6, and 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 | INCB54707 |
|---|---|
| Arm/Group Description | INCB54707 was administered at either 30,60, or 90 mg. All samples from different dose groups were combined for this analysis. |
| Measure Participants | 26 |
| Mean (Standard Deviation) [L/hr] |
5.27
(2.89)
|
| Title | Apparent Oral Volume of Distribution of INCB054707 |
|---|---|
| Description | To determine the systemic exposure to INCB054707. Dependent upon the final compartmental model describing INCB054707. |
| Time Frame | Predose Day 1, Week 4, and 8, Postdose Day1, week 2,4,6, and 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 | INCB54707 |
|---|---|
| Arm/Group Description | INCB54707 was administered at either 30,60, or 90 mg. All samples from different dose groups were combined for this analysis. |
| Measure Participants | 26 |
| Mean (Standard Deviation) [L] |
239
(85.7)
|
| Title | Proportion of Participants Achieving a Hidradenitis Suppurativa Clinical Response (HiSCR) at Each Visit |
|---|---|
| Description | HiSCR 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. |
| Time Frame | Weeks 1, 2, 4, 6, 8, Early Termination and Follow-up (Up to 3 months) |
Outcome Measure Data
| Analysis Population Description |
|---|
| Full Analysis Set Population. Full Analysis Set Population In placebo group 1 participant discontinued the study before week 1, second participant missed all the visits and only had early termination visit. In the 90mg group 1 participant missed week 1 visit and a second participant discontinued before the follow up visit |
| Arm/Group Title | Placebo | INCB054707 at 30 mg | INCB054707 at 60 mg | INCB054707 at 90 mg |
|---|---|---|---|---|
| Arm/Group Description | Placebo was administered QD over an 8 week treatment period. | INCB054707 was administered at 30 mg QD over an 8 week treatment period. | INCB054707 was administered at 60 mg QD over an 8 week treatment period. | INCB054707 was administered at 90 mg QD over an 8 week treatment period. |
| Measure Participants | 9 | 9 | 9 | 8 |
| Yes |
1
11.1%
|
1
11.1%
|
4
44.4%
|
2
25%
|
| No |
6
66.7%
|
8
88.9%
|
5
55.6%
|
5
62.5%
|
| Yes |
1
11.1%
|
6
66.7%
|
5
55.6%
|
4
50%
|
| No |
6
66.7%
|
3
33.3%
|
4
44.4%
|
4
50%
|
| Yes |
3
33.3%
|
5
55.6%
|
5
55.6%
|
5
62.5%
|
| No |
4
44.4%
|
4
44.4%
|
4
44.4%
|
3
37.5%
|
| Yes |
3
33.3%
|
3
33.3%
|
6
66.7%
|
6
75%
|
| No |
4
44.4%
|
6
66.7%
|
3
33.3%
|
2
25%
|
| Yes |
4
44.4%
|
5
55.6%
|
5
55.6%
|
7
87.5%
|
| No |
3
33.3%
|
4
44.4%
|
4
44.4%
|
1
12.5%
|
| Yes |
3
33.3%
|
3
33.3%
|
1
11.1%
|
4
50%
|
| No |
4
44.4%
|
6
66.7%
|
8
88.9%
|
3
37.5%
|
| Yes |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| No |
1
11.1%
|
0
0%
|
0
0%
|
0
0%
|
| Title | Proportion of Participants Achieving an AN Count of 0 to 2 at Each Visit |
|---|---|
| Description | AN defined as abscess and inflammatory nodule count. |
| Time Frame | Baseline,Weeks 1, 2, 4, 6, 8, Early Termination and Follow-up (Up to 3 months) |
Outcome Measure Data
| Analysis Population Description |
|---|
| Full Analysis Set Population In placebo group 1 participant discontinued the study before week 1, second participant missed all the visits and only had early termination visit. In the 90mg group 1 participant missed week 1 visit and a second participant discontinued before the follow up visit |
| Arm/Group Title | Placebo | INCB054707 at 30 mg | INCB054707 at 60 mg | INCB054707 at 90 mg |
|---|---|---|---|---|
| Arm/Group Description | Placebo was administered QD over an 8 week treatment period. | INCB054707 was administered at 30 mg QD over an 8 week treatment period. | INCB054707 was administered at 60 mg QD over an 8 week treatment period. | INCB054707 was administered at 90 mg QD over an 8 week treatment period. |
| Measure Participants | 9 | 9 | 9 | 8 |
| Yes |
0
0%
|
0
0%
|
0
0%
|
1
12.5%
|
| No |
9
100%
|
9
100%
|
9
100%
|
7
87.5%
|
| Yes |
0
0%
|
0
0%
|
2
22.2%
|
2
25%
|
| No |
7
77.8%
|
9
100%
|
7
77.8%
|
5
62.5%
|
| Yes |
0
0%
|
3
33.3%
|
5
55.6%
|
4
50%
|
| No |
7
77.8%
|
6
66.7%
|
4
44.4%
|
4
50%
|
| Yes |
2
22.2%
|
3
33.3%
|
6
66.7%
|
5
62.5%
|
| No |
5
55.6%
|
6
66.7%
|
3
33.3%
|
3
37.5%
|
| Yes |
3
33.3%
|
2
22.2%
|
5
55.6%
|
5
62.5%
|
| No |
4
44.4%
|
7
77.8%
|
4
44.4%
|
3
37.5%
|
| Yes |
4
44.4%
|
4
44.4%
|
4
44.4%
|
5
62.5%
|
| No |
3
33.3%
|
5
55.6%
|
5
55.6%
|
3
37.5%
|
| Yes |
1
11.1%
|
3
33.3%
|
0
0%
|
4
50%
|
| No |
6
66.7%
|
6
66.7%
|
9
100%
|
3
37.5%
|
| Yes |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| No |
1
11.1%
|
0
0%
|
0
0%
|
0
0%
|
| Title | Mean Change From Baseline in the Hidradenitis Suppurativa Pain Numeric Rating Scale (HS Pain NRS) Scores at Each Visit |
|---|---|
| Description | An 11-point scale used to assess the worst skin pain and the average skin pain due to HS. Skin pain ranges from 0 ("no skin pain") to 10 ("skin pain as bad as you can imagine"). |
| Time Frame | Baseline,Weeks 1, 2, 4, 6, 8, Early Termination and Follow-up (Up to 3 months) |
Outcome Measure Data
| Analysis Population Description |
|---|
| Full Analysis Set Population |
| Arm/Group Title | Placebo | INCB054707 at 30 mg | INCB054707 at 60 mg | INCB054707 at 90 mg |
|---|---|---|---|---|
| Arm/Group Description | Placebo was administered QD over an 8 week treatment period. | INCB054707 was administered at 30 mg QD over an 8 week treatment period. | INCB054707 was administered at 60 mg QD over an 8 week treatment period. | INCB054707 was administered at 90 mg QD over an 8 week treatment period. |
| Measure Participants | 9 | 9 | 9 | 8 |
| Mean change from Baseline to Week 1 |
0.2
(1.39)
|
-0.8
(1.13)
|
-0.3
(1.06)
|
-1.5
(1.04)
|
| Mean change from Baseline to Week 2 |
-0.1
(1.49)
|
-1.5
(1.18)
|
-1.1
(0.91)
|
-3.3
(3.06)
|
| Mean change from Baseline to Week 4 |
-0.3
(2.09)
|
-2.0
(2.02)
|
-1.4
(1.56)
|
-3.6
(3.30)
|
| Mean change from Baseline to Week 6 |
0.0
(3.49)
|
-0.9
(0.90)
|
-2.0
(1.55)
|
-3.4
(3.05)
|
| Mean change from Baseline to Week 8 |
0.3
(2.77)
|
-2.2
(2.18)
|
-1.4
(1.44)
|
-3.1
(3.28)
|
| Mean change from Baseline to Follow Up |
2.6
(2.62)
|
-2.7
(2.20)
|
-0.8
(0.97)
|
-1.2
(1.91)
|
| 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 | From baseline up to week 8 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Full Analysis Set Population |
| Arm/Group Title | Placebo | INCB054707 at 30 mg | INCB054707 at 60 mg | INCB054707 at 90 mg |
|---|---|---|---|---|
| Arm/Group Description | Placebo was administered QD over an 8 week treatment period. | INCB054707 was administered at 30 mg QD over an 8 week treatment period. | INCB054707 was administered at 60 mg QD over an 8 week treatment period. | INCB054707 was administered at 90 mg QD over an 8 week treatment period. |
| Measure Participants | 9 | 9 | 9 | 8 |
| Mean (Standard Deviation) [Units on a scale] |
-36.4
(35.83)
|
-41.9
(36.84)
|
-59.2
(48.48)
|
-54.6
(55.42)
|
| Title | Mean Change From Baseline in the Number of Draining Fistulas Count at Each Visit. |
|---|---|
| Description | Defined as fistulas that drain serous or purulent fluid, either spontaneously or by gentle palpation. |
| Time Frame | Baseline,Weeks 1, 2, 4, 6, 8 and Follow-up (Up to 3 months) |
Outcome Measure Data
| Analysis Population Description |
|---|
| Full Analysis Set Population |
| Arm/Group Title | Placebo | INCB054707 at 30 mg | INCB054707 at 60 mg | INCB054707 at 90 mg |
|---|---|---|---|---|
| Arm/Group Description | Placebo was administered QD over an 8 week treatment period. | INCB054707 was administered at 30 mg QD over an 8 week treatment period. | INCB054707 was administered at 60 mg QD over an 8 week treatment period. | INCB054707 was administered at 90 mg QD over an 8 week treatment period. |
| Measure Participants | 9 | 9 | 9 | 8 |
| Week 1 |
-0.1
(0.38)
|
-0.1
(1.27)
|
-0.8
(2.39)
|
-0.3
(0.49)
|
| Week 2 |
0.0
(1.53)
|
-0.9
(1.05)
|
-2.1
(3.48)
|
-0.8
(2.19)
|
| Week 4 |
-0.9
(2.79)
|
-0.6
(1.01)
|
-2.0
(3.57)
|
-0.9
(2.53)
|
| Week 6 |
-1.3
(2.69)
|
-0.4
(1.74)
|
-2.1
(3.30)
|
-0.6
(2.72)
|
| Week 8 |
-1.0
(3.06)
|
-0.3
(1.66)
|
-2.0
(3.35)
|
-0.6
(3.85)
|
| Follow Up |
-0.4
(3.10)
|
0.1
(1.69)
|
-2.2
(3.19)
|
-1.3
(3.86)
|
| 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 |
|---|
| Full Analysis Set Population |
| Arm/Group Title | Placebo | INCB054707 at 30 mg | INCB054707 at 60 mg | INCB054707 at 90 mg |
|---|---|---|---|---|
| Arm/Group Description | Placebo was administered QD over an 8 week treatment period. | INCB054707 was administered at 30 mg QD over an 8 week treatment period. | INCB054707 was administered at 60 mg QD over an 8 week treatment period. | INCB054707 was administered at 90 mg QD over an 8 week treatment period. |
| Measure Participants | 9 | 9 | 9 | 8 |
| Stage I |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Stage II |
4
44.4%
|
9
100%
|
5
55.6%
|
7
87.5%
|
| Stage III |
5
55.6%
|
0
0%
|
4
44.4%
|
1
12.5%
|
| No HS |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Stage I |
1
11.1%
|
3
33.3%
|
3
33.3%
|
0
0%
|
| Stage II |
3
33.3%
|
6
66.7%
|
5
55.6%
|
7
87.5%
|
| Stage III |
3
33.3%
|
0
0%
|
0
0%
|
0
0%
|
| No HS |
0
0%
|
0
0%
|
1
11.1%
|
1
12.5%
|
| Title | Proportions of Participants in Each HS Patient Global Impression of Change (PGIC) Category During the Treatment Period |
|---|---|
| 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 12 weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| Full Analysis Set Population |
| Arm/Group Title | Placebo | INCB054707 at 30 mg | INCB054707 at 60 mg | INCB054707 at 90 mg |
|---|---|---|---|---|
| Arm/Group Description | Placebo was administered QD over an 8 week treatment period. | INCB054707 was administered at 30 mg QD over an 8 week treatment period. | INCB054707 was administered at 60 mg QD over an 8 week treatment period. | INCB054707 was administered at 90 mg QD over an 8 week treatment period. |
| Measure Participants | 9 | 9 | 9 | 8 |
| 1 |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| 2 |
0
0%
|
1
11.1%
|
0
0%
|
0
0%
|
| 3 |
0
0%
|
3
33.3%
|
3
33.3%
|
3
37.5%
|
| 4 |
4
44.4%
|
2
22.2%
|
4
44.4%
|
2
25%
|
| 5 |
3
33.3%
|
3
33.3%
|
1
11.1%
|
2
25%
|
| 6 |
0
0%
|
0
0%
|
1
11.1%
|
0
0%
|
| 7 |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| 1 |
0
0%
|
1
11.1%
|
0
0%
|
0
0%
|
| 2 |
0
0%
|
1
11.1%
|
2
22.2%
|
3
37.5%
|
| 3 |
3
33.3%
|
4
44.4%
|
3
33.3%
|
1
12.5%
|
| 4 |
1
11.1%
|
2
22.2%
|
3
33.3%
|
3
37.5%
|
| 5 |
3
33.3%
|
1
11.1%
|
1
11.1%
|
1
12.5%
|
| 6 |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| 7 |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| 1 |
0
0%
|
1
11.1%
|
2
22.2%
|
0
0%
|
| 2 |
0
0%
|
1
11.1%
|
1
11.1%
|
3
37.5%
|
| 3 |
3
33.3%
|
2
22.2%
|
1
11.1%
|
1
12.5%
|
| 4 |
2
22.2%
|
2
22.2%
|
2
22.2%
|
2
25%
|
| 5 |
2
22.2%
|
1
11.1%
|
2
22.2%
|
2
25%
|
| 6 |
0
0%
|
1
11.1%
|
1
11.1%
|
0
0%
|
| 7 |
0
0%
|
1
11.1%
|
0
0%
|
0
0%
|
| 1 |
0
0%
|
0
0%
|
1
11.1%
|
0
0%
|
| 2 |
1
11.1%
|
1
11.1%
|
1
11.1%
|
2
25%
|
| 3 |
3
33.3%
|
2
22.2%
|
3
33.3%
|
2
25%
|
| 4 |
1
11.1%
|
4
44.4%
|
1
11.1%
|
4
50%
|
| 5 |
2
22.2%
|
1
11.1%
|
3
33.3%
|
0
0%
|
| 6 |
0
0%
|
1
11.1%
|
0
0%
|
0
0%
|
| 7 |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| 1 |
0
0%
|
0
0%
|
0
0%
|
1
12.5%
|
| 2 |
0
0%
|
3
33.3%
|
1
11.1%
|
0
0%
|
| 3 |
1
11.1%
|
1
11.1%
|
3
33.3%
|
1
12.5%
|
| 4 |
5
55.6%
|
3
33.3%
|
4
44.4%
|
2
25%
|
| 5 |
1
11.1%
|
1
11.1%
|
1
11.1%
|
3
37.5%
|
| 6 |
0
0%
|
1
11.1%
|
0
0%
|
1
12.5%
|
| 7 |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| 1 |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| 2 |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| 3 |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| 4 |
1
11.1%
|
0
0%
|
0
0%
|
0
0%
|
| 5 |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| 6 |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| 7 |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| 1 |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| 2 |
0
0%
|
1
11.1%
|
0
0%
|
0
0%
|
| 3 |
1
11.1%
|
1
11.1%
|
0
0%
|
0
0%
|
| 4 |
1
11.1%
|
2
22.2%
|
2
22.2%
|
1
12.5%
|
| 5 |
3
33.3%
|
2
22.2%
|
2
22.2%
|
3
37.5%
|
| 6 |
2
22.2%
|
3
33.3%
|
4
44.4%
|
0
0%
|
| 7 |
0
0%
|
0
0%
|
1
11.1%
|
3
37.5%
|
| Title | Actual Measurements in HS-PGIC at Each Visit |
|---|---|
| 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 12 weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| Full Analysis Set Population |
| Arm/Group Title | Placebo | INCB054707 at 30 mg | INCB054707 at 60 mg | INCB054707 at 90 mg |
|---|---|---|---|---|
| Arm/Group Description | Placebo was administered QD over an 8 week treatment period. | INCB054707 was administered at 30 mg QD over an 8 week treatment period. | INCB054707 was administered at 60 mg QD over an 8 week treatment period. | INCB054707 was administered at 90 mg QD over an 8 week treatment period. |
| Measure Participants | 9 | 9 | 9 | 8 |
| 1 |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| 2 |
0
0%
|
1
11.1%
|
0
0%
|
0
0%
|
| 3 |
0
0%
|
3
33.3%
|
3
33.3%
|
3
37.5%
|
| 4 |
4
44.4%
|
2
22.2%
|
4
44.4%
|
2
25%
|
| 5 |
3
33.3%
|
3
33.3%
|
1
11.1%
|
2
25%
|
| 6 |
0
0%
|
0
0%
|
1
11.1%
|
0
0%
|
| 7 |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| 1 |
0
0%
|
1
11.1%
|
0
0%
|
0
0%
|
| 2 |
0
0%
|
1
11.1%
|
2
22.2%
|
3
37.5%
|
| 3 |
3
33.3%
|
4
44.4%
|
3
33.3%
|
1
12.5%
|
| 4 |
1
11.1%
|
2
22.2%
|
3
33.3%
|
3
37.5%
|
| 5 |
3
33.3%
|
1
11.1%
|
1
11.1%
|
1
12.5%
|
| 6 |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| 7 |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| 1 |
0
0%
|
1
11.1%
|
2
22.2%
|
0
0%
|
| 2 |
0
0%
|
1
11.1%
|
1
11.1%
|
3
37.5%
|
| 3 |
3
33.3%
|
2
22.2%
|
1
11.1%
|
1
12.5%
|
| 4 |
2
22.2%
|
2
22.2%
|
2
22.2%
|
2
25%
|
| 5 |
2
22.2%
|
1
11.1%
|
2
22.2%
|
2
25%
|
| 6 |
0
0%
|
1
11.1%
|
1
11.1%
|
0
0%
|
| 7 |
0
0%
|
1
11.1%
|
0
0%
|
0
0%
|
| 1 |
0
0%
|
0
0%
|
1
11.1%
|
0
0%
|
| 2 |
1
11.1%
|
1
11.1%
|
1
11.1%
|
2
25%
|
| 3 |
3
33.3%
|
2
22.2%
|
3
33.3%
|
2
25%
|
| 4 |
1
11.1%
|
4
44.4%
|
1
11.1%
|
4
50%
|
| 5 |
2
22.2%
|
1
11.1%
|
3
33.3%
|
0
0%
|
| 6 |
0
0%
|
1
11.1%
|
0
0%
|
0
0%
|
| 7 |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| 1 |
0
0%
|
0
0%
|
0
0%
|
1
12.5%
|
| 2 |
0
0%
|
3
33.3%
|
1
11.1%
|
0
0%
|
| 3 |
1
11.1%
|
1
11.1%
|
3
33.3%
|
1
12.5%
|
| 4 |
5
55.6%
|
3
33.3%
|
4
44.4%
|
2
25%
|
| 5 |
1
11.1%
|
1
11.1%
|
1
11.1%
|
3
37.5%
|
| 6 |
0
0%
|
1
11.1%
|
0
0%
|
1
12.5%
|
| 7 |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| 1 |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| 2 |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| 3 |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| 4 |
1
11.1%
|
0
0%
|
0
0%
|
0
0%
|
| 5 |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| 6 |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| 7 |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| 1 |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| 2 |
0
0%
|
1
11.1%
|
0
0%
|
0
0%
|
| 3 |
1
11.1%
|
1
11.1%
|
0
0%
|
0
0%
|
| 4 |
1
11.1%
|
2
22.2%
|
2
22.2%
|
1
12.5%
|
| 5 |
3
33.3%
|
2
22.2%
|
2
22.2%
|
3
37.5%
|
| 6 |
2
22.2%
|
3
33.3%
|
4
44.4%
|
0
0%
|
| 7 |
0
0%
|
0
0%
|
1
11.1%
|
3
37.5%
|
| Title | Proportion of Participants With Change From Baseline 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 |
|---|
| Full Analysis Set Population |
| Arm/Group Title | Placebo | INCB054707 at 30 mg | INCB054707 at 60 mg | INCB054707 at 90 mg |
|---|---|---|---|---|
| Arm/Group Description | Placebo was administered QD over an 8 week treatment period. | INCB054707 was administered at 30 mg QD over an 8 week treatment period. | INCB054707 was administered at 60 mg QD over an 8 week treatment period. | INCB054707 was administered at 90 mg QD over an 8 week treatment period. |
| Measure Participants | 9 | 9 | 9 | 8 |
| Stage I |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Stage II |
4
44.4%
|
9
100%
|
5
55.6%
|
7
87.5%
|
| Stage III |
5
55.6%
|
0
0%
|
4
44.4%
|
1
12.5%
|
| No HS |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Missing |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Stage I |
1
11.1%
|
3
33.3%
|
3
33.3%
|
0
0%
|
| Stage II |
3
33.3%
|
6
66.7%
|
5
55.6%
|
7
87.5%
|
| Stage III |
3
33.3%
|
0
0%
|
0
0%
|
0
0%
|
| No HS |
0
0%
|
0
0%
|
1
11.1%
|
1
12.5%
|
| Missing |
2
22.2%
|
0
0%
|
0
0%
|
0
0%
|
| Title | Number of Treatment-emergent Adverse Events (TEAEs) |
|---|---|
| Description | TEAE is defined as any adverse event either reported for the first time or worsening of a pre-existing event after first dose of study drug. Grading was performed using guidance from the CTCAE v 4.03. A grade 3 and above would constitute as "severe". |
| Time Frame | Up to 12 weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| Full Analysis Set Population |
| Arm/Group Title | Placebo | INCB054707 at 30 mg | INCB054707 at 60 mg | INCB054707 at 90 mg |
|---|---|---|---|---|
| Arm/Group Description | Placebo was administered QD over an 8 week treatment period. | INCB054707 was administered at 30 mg QD over an 8 week treatment period. | INCB054707 was administered at 60 mg QD over an 8 week treatment period. | INCB054707 was administered at 90 mg QD over an 8 week treatment period. |
| Measure Participants | 9 | 9 | 9 | 8 |
| Grade 1 |
2
22.2%
|
6
66.7%
|
4
44.4%
|
1
12.5%
|
| Grade 2 |
2
22.2%
|
2
22.2%
|
2
22.2%
|
3
37.5%
|
| Grade 3 |
0
0%
|
0
0%
|
0
0%
|
3
37.5%
|
| Grade 4 |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
Adverse Events
| Time Frame | up to 12 weeks | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Adverse Event Reporting Description | ||||||||||
| Arm/Group Title | Placebo | INCB054707 at 30 mg | INCB054707 at 60 mg | INCB054707 at 90 mg | Total | |||||
| Arm/Group Description | Placebo was administered QD over an 8 week treatment period. | INCB054707 was administered at 30 mg QD over an 8 week treatment period. | INCB054707 was administered at 60 mg QD over an 8 week treatment period. | INCB054707 was administered at 90 mg QD over an 8 week treatment period. | Total | |||||
All Cause Mortality |
||||||||||
| Placebo | INCB054707 at 30 mg | INCB054707 at 60 mg | INCB054707 at 90 mg | Total | ||||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/9 (0%) | 0/9 (0%) | 0/9 (0%) | 0/8 (0%) | 0/35 (0%) | |||||
Serious Adverse Events |
||||||||||
| Placebo | INCB054707 at 30 mg | INCB054707 at 60 mg | INCB054707 at 90 mg | Total | ||||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/9 (0%) | 0/9 (0%) | 0/9 (0%) | 0/8 (0%) | 0/35 (0%) | |||||
Other (Not Including Serious) Adverse Events |
||||||||||
| Placebo | INCB054707 at 30 mg | INCB054707 at 60 mg | INCB054707 at 90 mg | Total | ||||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 4/9 (44.4%) | 8/9 (88.9%) | 6/9 (66.7%) | 7/8 (87.5%) | 25/35 (71.4%) | |||||
| Blood and lymphatic system disorders | ||||||||||
| Thrombocytopenia | 0/9 (0%) | 0 | 0/9 (0%) | 0 | 0/9 (0%) | 0 | 4/8 (50%) | 4 | 4/35 (11.4%) | 4 |
| Cardiac disorders | ||||||||||
| Palpitations | 0/9 (0%) | 0 | 1/9 (11.1%) | 1 | 0/9 (0%) | 0 | 0/8 (0%) | 0 | 1/35 (2.9%) | 1 |
| Gastrointestinal disorders | ||||||||||
| Abdominal distension | 0/9 (0%) | 0 | 0/9 (0%) | 0 | 1/9 (11.1%) | 1 | 0/8 (0%) | 0 | 1/35 (2.9%) | 1 |
| Abdominal pain | 1/9 (11.1%) | 1 | 1/9 (11.1%) | 1 | 0/9 (0%) | 0 | 0/8 (0%) | 0 | 2/35 (5.7%) | 2 |
| Abdominal pain upper | 0/9 (0%) | 0 | 1/9 (11.1%) | 1 | 0/9 (0%) | 0 | 0/8 (0%) | 0 | 1/35 (2.9%) | 1 |
| Constipation | 1/9 (11.1%) | 1 | 0/9 (0%) | 0 | 1/9 (11.1%) | 2 | 0/8 (0%) | 0 | 2/35 (5.7%) | 3 |
| Diarrhoea | 2/9 (22.2%) | 2 | 1/9 (11.1%) | 1 | 0/9 (0%) | 0 | 0/8 (0%) | 0 | 3/35 (8.6%) | 3 |
| Dyspepsia | 1/9 (11.1%) | 1 | 0/9 (0%) | 0 | 0/9 (0%) | 0 | 0/8 (0%) | 0 | 1/35 (2.9%) | 1 |
| Food poisoning | 0/9 (0%) | 0 | 1/9 (11.1%) | 1 | 0/9 (0%) | 0 | 0/8 (0%) | 0 | 1/35 (2.9%) | 1 |
| Nausea | 0/9 (0%) | 0 | 0/9 (0%) | 0 | 0/9 (0%) | 0 | 1/8 (12.5%) | 1 | 1/35 (2.9%) | 1 |
| Rectal haemorrhage | 1/9 (11.1%) | 1 | 0/9 (0%) | 0 | 0/9 (0%) | 0 | 0/8 (0%) | 0 | 1/35 (2.9%) | 1 |
| General disorders | ||||||||||
| Chest pain | 0/9 (0%) | 0 | 0/9 (0%) | 0 | 0/9 (0%) | 0 | 1/8 (12.5%) | 1 | 1/35 (2.9%) | 1 |
| Exercise tolerance decreased | 1/9 (11.1%) | 1 | 0/9 (0%) | 0 | 0/9 (0%) | 0 | 0/8 (0%) | 0 | 1/35 (2.9%) | 1 |
| Fatigue | 1/9 (11.1%) | 1 | 1/9 (11.1%) | 1 | 2/9 (22.2%) | 2 | 3/8 (37.5%) | 3 | 7/35 (20%) | 7 |
| Oedema peripheral | 0/9 (0%) | 0 | 1/9 (11.1%) | 1 | 0/9 (0%) | 0 | 0/8 (0%) | 0 | 1/35 (2.9%) | 1 |
| Pain | 0/9 (0%) | 0 | 0/9 (0%) | 0 | 0/9 (0%) | 0 | 1/8 (12.5%) | 1 | 1/35 (2.9%) | 1 |
| Pyrexia | 0/9 (0%) | 0 | 0/9 (0%) | 0 | 0/9 (0%) | 0 | 1/8 (12.5%) | 1 | 1/35 (2.9%) | 1 |
| Vessel puncture site haemorrhage | 1/9 (11.1%) | 1 | 1/9 (11.1%) | 1 | 0/9 (0%) | 0 | 0/8 (0%) | 0 | 2/35 (5.7%) | 2 |
| Infections and infestations | ||||||||||
| Folliculitis | 1/9 (11.1%) | 1 | 2/9 (22.2%) | 2 | 1/9 (11.1%) | 1 | 0/8 (0%) | 0 | 4/35 (11.4%) | 4 |
| Gastroenteritis | 0/9 (0%) | 0 | 0/9 (0%) | 0 | 2/9 (22.2%) | 2 | 0/8 (0%) | 0 | 2/35 (5.7%) | 2 |
| Influenza | 0/9 (0%) | 0 | 1/9 (11.1%) | 1 | 0/9 (0%) | 0 | 0/8 (0%) | 0 | 1/35 (2.9%) | 1 |
| Nasopharyngitis | 1/9 (11.1%) | 1 | 1/9 (11.1%) | 1 | 2/9 (22.2%) | 2 | 0/8 (0%) | 0 | 4/35 (11.4%) | 4 |
| Oral herpes | 1/9 (11.1%) | 1 | 1/9 (11.1%) | 1 | 0/9 (0%) | 0 | 0/8 (0%) | 0 | 2/35 (5.7%) | 2 |
| Sinusitis | 0/9 (0%) | 0 | 0/9 (0%) | 0 | 0/9 (0%) | 0 | 1/8 (12.5%) | 1 | 1/35 (2.9%) | 1 |
| Tinea pedis | 0/9 (0%) | 0 | 1/9 (11.1%) | 1 | 0/9 (0%) | 0 | 0/8 (0%) | 0 | 1/35 (2.9%) | 1 |
| Tonsillitis | 0/9 (0%) | 0 | 1/9 (11.1%) | 1 | 0/9 (0%) | 0 | 0/8 (0%) | 0 | 1/35 (2.9%) | 1 |
| Upper respiratory tract infection | 0/9 (0%) | 0 | 0/9 (0%) | 0 | 0/9 (0%) | 0 | 1/8 (12.5%) | 1 | 1/35 (2.9%) | 1 |
| Injury, poisoning and procedural complications | ||||||||||
| Animal bite | 0/9 (0%) | 0 | 1/9 (11.1%) | 1 | 0/9 (0%) | 0 | 0/8 (0%) | 0 | 1/35 (2.9%) | 1 |
| Fall | 0/9 (0%) | 0 | 1/9 (11.1%) | 1 | 0/9 (0%) | 0 | 0/8 (0%) | 0 | 1/35 (2.9%) | 1 |
| Rib fracture | 0/9 (0%) | 0 | 0/9 (0%) | 0 | 0/9 (0%) | 0 | 1/8 (12.5%) | 1 | 1/35 (2.9%) | 1 |
| Metabolism and nutrition disorders | ||||||||||
| Decreased appetite | 0/9 (0%) | 0 | 0/9 (0%) | 0 | 1/9 (11.1%) | 1 | 0/8 (0%) | 0 | 1/35 (2.9%) | 1 |
| Hypertriglyceridaemia | 0/9 (0%) | 0 | 1/9 (11.1%) | 1 | 0/9 (0%) | 0 | 0/8 (0%) | 0 | 1/35 (2.9%) | 1 |
| Hypoglycaemia | 0/9 (0%) | 0 | 1/9 (11.1%) | 1 | 0/9 (0%) | 0 | 0/8 (0%) | 0 | 1/35 (2.9%) | 1 |
| Musculoskeletal and connective tissue disorders | ||||||||||
| Arthralgia | 0/9 (0%) | 0 | 1/9 (11.1%) | 1 | 0/9 (0%) | 0 | 1/8 (12.5%) | 1 | 2/35 (5.7%) | 2 |
| Back pain | 0/9 (0%) | 0 | 0/9 (0%) | 0 | 1/9 (11.1%) | 1 | 0/8 (0%) | 0 | 1/35 (2.9%) | 1 |
| Torticollis | 1/9 (11.1%) | 1 | 0/9 (0%) | 0 | 0/9 (0%) | 0 | 0/8 (0%) | 0 | 1/35 (2.9%) | 1 |
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||||||||||
| Basal cell carcinoma | 0/9 (0%) | 0 | 0/9 (0%) | 0 | 1/9 (11.1%) | 1 | 0/8 (0%) | 0 | 1/35 (2.9%) | 1 |
| Nervous system disorders | ||||||||||
| Disturbance in attention | 0/9 (0%) | 0 | 0/9 (0%) | 0 | 1/9 (11.1%) | 1 | 1/8 (12.5%) | 2 | 2/35 (5.7%) | 3 |
| Dizziness | 1/9 (11.1%) | 1 | 0/9 (0%) | 0 | 0/9 (0%) | 0 | 0/8 (0%) | 0 | 1/35 (2.9%) | 1 |
| Headache | 2/9 (22.2%) | 2 | 0/9 (0%) | 0 | 2/9 (22.2%) | 3 | 2/8 (25%) | 4 | 6/35 (17.1%) | 9 |
| Hypoaesthesia | 0/9 (0%) | 0 | 1/9 (11.1%) | 1 | 0/9 (0%) | 0 | 0/8 (0%) | 0 | 1/35 (2.9%) | 1 |
| Migraine | 0/9 (0%) | 0 | 0/9 (0%) | 0 | 1/9 (11.1%) | 2 | 0/8 (0%) | 0 | 1/35 (2.9%) | 2 |
| Sinus headache | 0/9 (0%) | 0 | 0/9 (0%) | 0 | 1/9 (11.1%) | 1 | 0/8 (0%) | 0 | 1/35 (2.9%) | 1 |
| Psychiatric disorders | ||||||||||
| Insomnia | 0/9 (0%) | 0 | 1/9 (11.1%) | 1 | 0/9 (0%) | 0 | 0/8 (0%) | 0 | 1/35 (2.9%) | 1 |
| Restlessness | 0/9 (0%) | 0 | 0/9 (0%) | 0 | 0/9 (0%) | 0 | 1/8 (12.5%) | 2 | 1/35 (2.9%) | 2 |
| Sleep disorder | 1/9 (11.1%) | 1 | 0/9 (0%) | 0 | 0/9 (0%) | 0 | 0/8 (0%) | 0 | 1/35 (2.9%) | 1 |
| Reproductive system and breast disorders | ||||||||||
| Polymenorrhoea | 0/9 (0%) | 0 | 1/9 (11.1%) | 1 | 0/9 (0%) | 0 | 0/8 (0%) | 0 | 1/35 (2.9%) | 1 |
| Respiratory, thoracic and mediastinal disorders | ||||||||||
| Cough | 1/9 (11.1%) | 1 | 0/9 (0%) | 0 | 0/9 (0%) | 0 | 0/8 (0%) | 0 | 1/35 (2.9%) | 1 |
| Oropharyngeal pain | 0/9 (0%) | 0 | 1/9 (11.1%) | 1 | 0/9 (0%) | 0 | 0/8 (0%) | 0 | 1/35 (2.9%) | 1 |
| Skin and subcutaneous tissue disorders | ||||||||||
| Acne | 0/9 (0%) | 0 | 0/9 (0%) | 0 | 0/9 (0%) | 0 | 1/8 (12.5%) | 1 | 1/35 (2.9%) | 1 |
| Acne cystic | 1/9 (11.1%) | 1 | 0/9 (0%) | 0 | 0/9 (0%) | 0 | 0/8 (0%) | 0 | 1/35 (2.9%) | 1 |
| Seborrhoeic dermatitis | 0/9 (0%) | 0 | 1/9 (11.1%) | 1 | 0/9 (0%) | 0 | 0/8 (0%) | 0 | 1/35 (2.9%) | 1 |
| Telangiectasia | 0/9 (0%) | 0 | 0/9 (0%) | 0 | 1/9 (11.1%) | 1 | 0/8 (0%) | 0 | 1/35 (2.9%) | 1 |
| Surgical and medical procedures | ||||||||||
| Endodontic procedure | 0/9 (0%) | 0 | 0/9 (0%) | 0 | 1/9 (11.1%) | 1 | 0/8 (0%) | 0 | 1/35 (2.9%) | 1 |
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 |
|---|---|
| Organization | Incyte Corporation |
| Phone | 1-855-463-3463 |
| medinfo@incyte.com |
Responsible Party:
Incyte Corporation
ClinicalTrials.gov Identifier:
NCT03607487
Other Study ID Numbers:
- INCB 54707-203
First Posted:
Jul 31, 2018
Last Update Posted:
Mar 2, 2022
Last Verified:
Feb 1, 2022