A Phase 2 interventional study of INCB054707 and Placebo in Hidradenitis Suppurativa, sponsored by Incyte Corporation. Completed at 13 sites in 3 countries. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2025-08-21.
Sponsored by Incyte Corporation · Phase 2, Interventional, and Treatment
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.
277 studies on the registry are indexed under Hidradenitis Suppurativa; 88 are open to participants now.
This study's enrollment of 35 is below the median of 45 across 195 interventional studies indexed under Hidradenitis Suppurativa.
Browse Hidradenitis Suppurativa studies →Incyte Corporation is the lead sponsor of 286 studies on the registry; 37 are open to participants now.
Of its 144 completed or terminated interventional studies of FDA-regulated products, 93 (65%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
INCB054707 at the Cohort 1 dose or placebo.
Drug: INCB054707 · Drug: Placebo
INCB054707 at the Cohort 2 dose or placebo.
Drug: INCB054707 · Drug: Placebo
INCB054707 at the Cohort 3 dose or placebo.
Drug: INCB054707 · Drug: Placebo
INCB054707 tablet administered orally once daily at the protocol-defined dose.
Also known as: Povorcitinib
Placebo tablet administered orally once daily.
Number of Treatment-emergent Adverse Events (TEAEs)
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
Apparent Oral Clearance of INCB054707
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
Apparent Oral Volume of Distribution of INCB054707
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
Proportion of Participants Achieving a Hidradenitis Suppurativa Clinical Response (HiSCR) at Each Visit
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)
Proportion of Participants Achieving an AN Count of 0 to 2 at Each Visit
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)
Mean Change From Baseline in the Hidradenitis Suppurativa Pain Numeric Rating Scale (HS Pain NRS) Scores at Each Visit
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)
Mean Change From Baseline in the Modified Sartorius Scale Score
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
Mean Change From Baseline in the Number of Draining Fistulas Count at Each Visit.
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)
Proportion of Participants at Each Category of Hurley Stage
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
Proportions of Participants in Each HS Patient Global Impression of Change (PGIC) Category During the Treatment Period
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
Actual Measurements in HS-PGIC at Each Visit
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
Proportion of Participants With Change From Baseline Hurley Stage
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
The study was conducted at 9 different sites in Canada, 2 different sites in Germany and 1 site in Denmark
| Milestone | Placebo | INCB054707 at 30 mg | INCB054707 at 60 mg | INCB054707 at 90 mg |
|---|---|---|---|---|
| Started | 9 | 9 | 9 | 8 |
| Completed | 7 | 9 | 9 | 7 |
| Not completed | 2 | 0 | 0 | 1 |
| Withdrew: Withdrawal by subject | 2 | 0 | 0 | 1 |
To determine the systemic exposure to INCB054707. Dependent upon the final compartmental model describing INCB054707.
| L/hr | INCB54707 |
|---|---|
| Apparent Oral Clearance of INCB054707 | 5.27 ± 2.89 |
To determine the systemic exposure to INCB054707. Dependent upon the final compartmental model describing INCB054707.
| L | INCB54707 |
|---|---|
| Apparent Oral Volume of Distribution of INCB054707 | 239 ± 85.7 |
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.
| Participants | Placebo | INCB054707 at 30 mg | INCB054707 at 60 mg | INCB054707 at 90 mg |
|---|---|---|---|---|
| Week 1 — Yes | 1 | 1 | 4 | 2 |
| Week 1 — No | 6 | 8 | 5 | 5 |
| Week 2 — Yes | 1 | 6 | 5 | 4 |
| Week 2 — No | 6 | 3 | 4 | 4 |
| Week 4 — Yes | 3 | 5 | 5 | 5 |
| Week 4 — No | 4 | 4 | 4 | 3 |
| Week 6 — Yes | 3 | 3 | 6 | 6 |
| Week 6 — No | 4 | 6 | 3 | 2 |
| Week 8 — Yes | 4 | 5 | 5 | 7 |
| Week 8 — No | 3 | 4 | 4 | 1 |
| Follow Up — Yes | 3 | 3 | 1 | 4 |
| Follow Up — No | 4 | 6 | 8 | 3 |
| Early Termination — Yes | 0 | 0 | 0 | 0 |
| Early Termination — No | 1 | 0 | 0 | 0 |
AN defined as abscess and inflammatory nodule count.
| Participants | Placebo | INCB054707 at 30 mg | INCB054707 at 60 mg | INCB054707 at 90 mg |
|---|---|---|---|---|
| Baseline — Yes | 0 | 0 | 0 | 1 |
| Baseline — No | 9 | 9 | 9 | 7 |
| Week 1 — Yes | 0 | 0 | 2 | 2 |
| Week 1 — No | 7 | 9 | 7 | 5 |
| Week 2 — Yes | 0 | 3 | 5 | 4 |
| Week 2 — No | 7 | 6 | 4 | 4 |
| Week 4 — Yes | 2 | 3 | 6 | 5 |
| Week 4 — No | 5 | 6 | 3 | 3 |
| Week 6 — Yes | 3 | 2 | 5 | 5 |
| Week 6 — No | 4 | 7 | 4 | 3 |
| Week 8 — Yes | 4 | 4 | 4 | 5 |
| Week 8 — No | 3 | 5 | 5 | 3 |
| Follow Up — Yes | 1 | 3 | 0 | 4 |
| Follow Up — No | 6 | 6 | 9 | 3 |
| Early Termination — Yes | 0 | 0 | 0 | 0 |
| Early Termination — No | 1 | 0 | 0 | 0 |
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").
| Units on a scale | Placebo | INCB054707 at 30 mg | INCB054707 at 60 mg | INCB054707 at 90 mg |
|---|---|---|---|---|
| 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 |
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.
| Units on a scale | Placebo | INCB054707 at 30 mg | INCB054707 at 60 mg | INCB054707 at 90 mg |
|---|---|---|---|---|
| Mean Change From Baseline in the Modified Sartorius Scale Score | -36.4 ± 35.83 | -41.9 ± 36.84 | -59.2 ± 48.48 | -54.6 ± 55.42 |
Defined as fistulas that drain serous or purulent fluid, either spontaneously or by gentle palpation.
| Number of Fistulas | Placebo | INCB054707 at 30 mg | INCB054707 at 60 mg | INCB054707 at 90 mg |
|---|---|---|---|---|
| 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 |
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.
| Participants | Placebo | INCB054707 at 30 mg | INCB054707 at 60 mg | INCB054707 at 90 mg |
|---|---|---|---|---|
| Baseline — Stage I | 0 | 0 | 0 | 0 |
| Baseline — Stage II | 4 | 9 | 5 | 7 |
| Baseline — Stage III | 5 | 0 | 4 | 1 |
| Baseline — No HS | 0 | 0 | 0 | 0 |
| Week 8 — Stage I | 1 | 3 | 3 | 0 |
| Week 8 — Stage II | 3 | 6 | 5 | 7 |
| Week 8 — Stage III | 3 | 0 | 0 | 0 |
| Week 8 — No HS | 0 | 0 | 1 | 1 |
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.
| Participants | Placebo | INCB054707 at 30 mg | INCB054707 at 60 mg | INCB054707 at 90 mg |
|---|---|---|---|---|
| Week 1 — 1 | 0 | 0 | 0 | 0 |
| Week 1 — 2 | 0 | 1 | 0 | 0 |
| Week 1 — 3 | 0 | 3 | 3 | 3 |
| Week 1 — 4 | 4 | 2 | 4 | 2 |
| Week 1 — 5 | 3 | 3 | 1 | 2 |
| Week 1 — 6 | 0 | 0 | 1 | 0 |
| Week 1 — 7 | 0 | 0 | 0 | 0 |
| Week 2 — 1 | 0 | 1 | 0 | 0 |
| Week 2 — 2 | 0 | 1 | 2 | 3 |
| Week 2 — 3 | 3 | 4 | 3 | 1 |
| Week 2 — 4 | 1 | 2 | 3 | 3 |
| Week 2 — 5 | 3 | 1 | 1 | 1 |
| Week 2 — 6 | 0 | 0 | 0 | 0 |
| Week 2 — 7 | 0 | 0 | 0 | 0 |
| Week 4 — 1 | 0 | 1 | 2 | 0 |
| Week 4 — 2 | 0 | 1 | 1 | 3 |
| Week 4 — 3 | 3 | 2 | 1 | 1 |
| Week 4 — 4 | 2 | 2 | 2 | 2 |
| Week 4 — 5 | 2 | 1 | 2 | 2 |
| Week 4 — 6 | 0 | 1 | 1 | 0 |
| Week 4 — 7 | 0 | 1 | 0 | 0 |
| Week 6 — 1 | 0 | 0 | 1 | 0 |
| Week 6 — 2 | 1 | 1 | 1 | 2 |
| Week 6 — 3 | 3 | 2 | 3 | 2 |
| Week 6 — 4 | 1 | 4 | 1 | 4 |
| Week 6 — 5 | 2 | 1 | 3 | 0 |
| Week 6 — 6 | 0 | 1 | 0 | 0 |
| Week 6 — 7 | 0 | 0 | 0 | 0 |
| Week 8 — 1 | 0 | 0 | 0 | 1 |
| Week 8 — 2 | 0 | 3 | 1 | 0 |
| Week 8 — 3 | 1 | 1 | 3 | 1 |
| Week 8 — 4 | 5 | 3 | 4 | 2 |
| Week 8 — 5 | 1 | 1 | 1 | 3 |
| Week 8 — 6 | 0 | 1 | 0 | 1 |
| Week 8 — 7 | 0 | 0 | 0 | 0 |
| Early Termination — 1 | 0 | 0 | 0 | 0 |
| Early Termination — 2 | 0 | 0 | 0 | 0 |
| Early Termination — 3 | 0 | 0 | 0 | 0 |
| Early Termination — 4 | 1 | 0 | 0 | 0 |
| Early Termination — 5 | 0 | 0 | 0 | 0 |
| Early Termination — 6 | 0 | 0 | 0 | 0 |
| Early Termination — 7 | 0 | 0 | 0 | 0 |
| Follow Up — 1 | 0 | 0 | 0 | 0 |
| Follow Up — 2 | 0 | 1 | 0 | 0 |
| Follow Up — 3 | 1 | 1 | 0 | 0 |
| Follow Up — 4 | 1 | 2 | 2 | 1 |
| Follow Up — 5 | 3 | 2 | 2 | 3 |
| Follow Up — 6 | 2 | 3 | 4 | 0 |
| Follow Up — 7 | 0 | 0 | 1 | 3 |
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.
| Participants | Placebo | INCB054707 at 30 mg | INCB054707 at 60 mg | INCB054707 at 90 mg |
|---|---|---|---|---|
| Week 1 — 1 | 0 | 0 | 0 | 0 |
| Week 1 — 2 | 0 | 1 | 0 | 0 |
| Week 1 — 3 | 0 | 3 | 3 | 3 |
| Week 1 — 4 | 4 | 2 | 4 | 2 |
| Week 1 — 5 | 3 | 3 | 1 | 2 |
| Week 1 — 6 | 0 | 0 | 1 | 0 |
| Week 1 — 7 | 0 | 0 | 0 | 0 |
| Week 2 — 1 | 0 | 1 | 0 | 0 |
| Week 2 — 2 | 0 | 1 | 2 | 3 |
| Week 2 — 3 | 3 | 4 | 3 | 1 |
| Week 2 — 4 | 1 | 2 | 3 | 3 |
| Week 2 — 5 | 3 | 1 | 1 | 1 |
| Week 2 — 6 | 0 | 0 | 0 | 0 |
| Week 2 — 7 | 0 | 0 | 0 | 0 |
| Week 4 — 1 | 0 | 1 | 2 | 0 |
| Week 4 — 2 | 0 | 1 | 1 | 3 |
| Week 4 — 3 | 3 | 2 | 1 | 1 |
| Week 4 — 4 | 2 | 2 | 2 | 2 |
| Week 4 — 5 | 2 | 1 | 2 | 2 |
| Week 4 — 6 | 0 | 1 | 1 | 0 |
| Week 4 — 7 | 0 | 1 | 0 | 0 |
| Week 6 — 1 | 0 | 0 | 1 | 0 |
| Week 6 — 2 | 1 | 1 | 1 | 2 |
| Week 6 — 3 | 3 | 2 | 3 | 2 |
| Week 6 — 4 | 1 | 4 | 1 | 4 |
| Week 6 — 5 | 2 | 1 | 3 | 0 |
| Week 6 — 6 | 0 | 1 | 0 | 0 |
| Week 6 — 7 | 0 | 0 | 0 | 0 |
| Week 8 — 1 | 0 | 0 | 0 | 1 |
| Week 8 — 2 | 0 | 3 | 1 | 0 |
| Week 8 — 3 | 1 | 1 | 3 | 1 |
| Week 8 — 4 | 5 | 3 | 4 | 2 |
| Week 8 — 5 | 1 | 1 | 1 | 3 |
| Week 8 — 6 | 0 | 1 | 0 | 1 |
| Week 8 — 7 | 0 | 0 | 0 | 0 |
| Early Termination — 1 | 0 | 0 | 0 | 0 |
| Early Termination — 2 | 0 | 0 | 0 | 0 |
| Early Termination — 3 | 0 | 0 | 0 | 0 |
| Early Termination — 4 | 1 | 0 | 0 | 0 |
| Early Termination — 5 | 0 | 0 | 0 | 0 |
| Early Termination — 6 | 0 | 0 | 0 | 0 |
| Early Termination — 7 | 0 | 0 | 0 | 0 |
| Follow Up — 1 | 0 | 0 | 0 | 0 |
| Follow Up — 2 | 0 | 1 | 0 | 0 |
| Follow Up — 3 | 1 | 1 | 0 | 0 |
| Follow Up — 4 | 1 | 2 | 2 | 1 |
| Follow Up — 5 | 3 | 2 | 2 | 3 |
| Follow Up — 6 | 2 | 3 | 4 | 0 |
| Follow Up — 7 | 0 | 0 | 1 | 3 |
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.
| Participants | Placebo | INCB054707 at 30 mg | INCB054707 at 60 mg | INCB054707 at 90 mg |
|---|---|---|---|---|
| Baseline — Stage I | 0 | 0 | 0 | 0 |
| Baseline — Stage II | 4 | 9 | 5 | 7 |
| Baseline — Stage III | 5 | 0 | 4 | 1 |
| Baseline — No HS | 0 | 0 | 0 | 0 |
| Baseline — Missing | 0 | 0 | 0 | 0 |
| Week 8 — Stage I | 1 | 3 | 3 | 0 |
| Week 8 — Stage II | 3 | 6 | 5 | 7 |
| Week 8 — Stage III | 3 | 0 | 0 | 0 |
| Week 8 — No HS | 0 | 0 | 1 | 1 |
| Week 8 — Missing | 2 | 0 | 0 | 0 |
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".
| Participants | Placebo | INCB054707 at 30 mg | INCB054707 at 60 mg | INCB054707 at 90 mg |
|---|---|---|---|---|
| Grade 1 | 2 | 6 | 4 | 1 |
| Grade 2 | 2 | 2 | 2 | 3 |
| Grade 3 | 0 | 0 | 0 | 3 |
| Grade 4 | 0 | 0 | 0 | 0 |
Collected over up to 12 weeks. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Placebo | 0/9 (0%) | 0/9 (0%) | 4/9 (44.4%) |
| INCB054707 at 30 mg | 0/9 (0%) | 0/9 (0%) | 8/9 (88.9%) |
| INCB054707 at 60 mg | 0/9 (0%) | 0/9 (0%) | 6/9 (66.7%) |
| INCB054707 at 90 mg | 0/8 (0%) | 0/8 (0%) | 7/8 (87.5%) |
| Total | 0/35 (0%) | 0/35 (0%) | 25/35 (71.4%) |
| Event | Placebo | INCB054707 at 30 mg | INCB054707 at 60 mg | INCB054707 at 90 mg | Total |
|---|---|---|---|---|---|
| ThrombocytopeniaBlood and lymphatic system disorders | 0/9 | 0/9 | 0/9 | 4/8 | 4/35 |
| FatigueGeneral disorders | 1/9 | 1/9 | 2/9 | 3/8 | 7/35 |
| HeadacheNervous system disorders | 2/9 | 0/9 | 2/9 | 2/8 | 6/35 |
| DiarrhoeaGastrointestinal disorders | 2/9 | 1/9 | 0/9 | 0/8 | 3/35 |
| FolliculitisInfections and infestations | 1/9 | 2/9 | 1/9 | 0/8 | 4/35 |
| GastroenteritisInfections and infestations | 0/9 | 0/9 | 2/9 | 0/8 | 2/35 |
| NasopharyngitisInfections and infestations | 1/9 | 1/9 | 2/9 | 0/8 | 4/35 |
| AcneSkin and subcutaneous tissue disorders | 0/9 | 0/9 | 0/9 | 1/8 | 1/35 |
| ArthralgiaMusculoskeletal and connective tissue disorders | 0/9 | 1/9 | 0/9 | 1/8 | 2/35 |
| Chest painGeneral disorders | 0/9 | 0/9 | 0/9 | 1/8 | 1/35 |
| Age, Continuous(years) | Placebo | INCB054707 at 30 mg | INCB054707 at 60 mg | INCB054707 at 90 mg | Total |
|---|---|---|---|---|---|
| Mean | 40.3 ± 16.70 | 41.0 ± 11.53 | 42.2 ± 11.96 | 42.8 ± 14.62 | 41.5 ± 13.25 |
| Sex: Female, Male(Participants) | Placebo | INCB054707 at 30 mg | INCB054707 at 60 mg | INCB054707 at 90 mg | Total |
|---|---|---|---|---|---|
| Female | 8 | 7 | 8 | 5 | 28 |
| Male | 1 | 2 | 1 | 3 | 7 |
| Race/Ethnicity, Customized(Participants) | Placebo | INCB054707 at 30 mg | INCB054707 at 60 mg | INCB054707 at 90 mg | Total |
|---|---|---|---|---|---|
| White/Caucasian | 8 | 7 | 9 | 7 | 31 |
| Black/African-American | 0 | 0 | 0 | 1 | 1 |
| American-Indian/Alaska Native | 0 | 2 | 0 | 0 | 2 |
| Other | 1 | 0 | 0 | 0 | 1 |
| Race/Ethnicity, Customized(Participants) | Placebo | INCB054707 at 30 mg | INCB054707 at 60 mg | INCB054707 at 90 mg | Total |
|---|---|---|---|---|---|
| Hispanic or Latino | 0 | 1 | 0 | 0 | 1 |
| Not Hispanic or Latino | 9 | 7 | 9 | 8 | 33 |
| Not Reported | 0 | 1 | 0 | 0 | 1 |
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