Actively Recruiting
A Phase 2, Open-Label Study to Evaluate the Safety, Pharmacokinetics, and Efficacy of Povorcitinib in Adolescents With Moderate to Severe Hidradenitis Suppurativa
Led by Incyte Corporation · Updated on 2026-05-27
40
Participants Needed
29
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the pharmacokinetics, safety, and effectiveness of povorcitinib in adolescents aged 12 to 17 years with moderate to severe hidradenitis suppurativa. This phase 2, open-label study aims to understand how the drug behaves in the body and its impact on this skin condition over a 54-week period. Participants have moderate to severe disease and have not responded adequately to previous systemic treatments. Participants will be assigned to receive one of two doses of povorcitinib orally as tablets for 54 weeks. The study monitors how the drug is absorbed, distributed, and cleared from the body during the first 24 weeks, while safety and skin condition responses are assessed throughout the full treatment period. The study does not use randomization or blinding. During the study, participants will undergo regular evaluations including monitoring of treatment-emergent adverse events and measurement of drug levels in the blood. Researchers will also assess changes in skin lesions, abscesses, draining tunnels, and skin pain using standardized clinical response criteria and quality of life questionnaires. This comprehensive monitoring helps understand the drug's safety and impact over the 54-week treatment period.
CONDITIONS
Brief Title
Pharmacokinetics, Safety, and Efficacy of Povorcitinib in Adolescent Participants With Moderate to Severe Hidradenitis Suppurativa
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Aged 12 to under 18 years at the time of informed consent/assent signing
- Body weight of at least 30 kg at screening and baseline visits
- Diagnosis of moderate to severe hidradenitis suppurativa for at least 3 months before screening
- Total abscess and inflammatory nodule count of 5 or more at screening and baseline visits
- Hidradenitis suppurativa lesions corresponding to refined Hurley Stage IB, IC, IIB, IIC, or III at screening and baseline visits
- History of inadequate response to at least 3 months of one conventional systemic therapy for hidradenitis suppurativa, or intolerance/contraindication to such treatment
- Agreement to use contraception
- Willingness and ability to comply with study protocol and procedures
- Further inclusion criteria apply
You will not qualify if you...
- Presence of more than 20 draining tunnels (fistulas) at screening or baseline visits
- Women who are pregnant, considering pregnancy, or breastfeeding
- Medical history including thrombocytopenia, coagulopathy, platelet dysfunction, Q-wave interval abnormalities, certain infections, cancer, lymphoproliferative disorders, or other investigator-discretionary conditions
- Laboratory values outside protocol-defined ranges
- Further exclusion criteria apply
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 54 weeks
Participants receive oral povorcitinib tablets as the active treatment for moderate to severe hidradenitis suppurativa.
Regular visits during treatment period
Trial Site Locations
Total: 29 locations
1
University of Alabama At Birmingham
Birmingham, Alabama, United States, 35233
Not Yet Recruiting
2
Medical Dermatology Specialists Phoenix
Phoenix, Arizona, United States, 85006
Actively Recruiting
3
Saguaro Dermatology
Phoenix, Arizona, United States, 85008
Actively Recruiting
4
Uconn Health
Farmington, Connecticut, United States, 06030
Not Yet Recruiting
5
University of Miami Miller School of Medicine
Miami, Florida, United States, 33136
Actively Recruiting
6
Skin Research of South Florida, Llc
Miami, Florida, United States, 33173
Actively Recruiting
7
Trueblue Clinical Research
Tampa, Florida, United States, 33607
Actively Recruiting
8
Advanced Medical Research Pc
Sandy Springs, Georgia, United States, 30328
Actively Recruiting
9
Endeavor Health Medical Group
Skokie, Illinois, United States, 60077
Actively Recruiting
10
Dermatology Skin Cancer Center Leawood
Leawood, Kansas, United States, 66211
Actively Recruiting
11
Equity Medical
Bowling Green, Kentucky, United States, 42104
Actively Recruiting
12
Johns Hopkins Univ Schl of Medicine
Baltimore, Maryland, United States, 21205
Actively Recruiting
13
Skin Oasis Dermatology
Gambrills, Maryland, United States, 21054
Not Yet Recruiting
14
Boston Childrens Hospital
Boston, Massachusetts, United States, 02115
Not Yet Recruiting
15
Oakland Hills Dermatology Pc
Auburn Hills, Michigan, United States, 48326
Actively Recruiting
16
Wayne State University Physician Group Dermatology
Detroit, Michigan, United States, 48201
Actively Recruiting
17
Revival Research Institute, Llc Troy
Troy, Michigan, United States, 48084
Actively Recruiting
18
Washington University
St Louis, Missouri, United States, 63110
Actively Recruiting
19
Boeson Research Missoula 2825 Fort Missoula Rd
Missoula, Montana, United States, 59804
Actively Recruiting
20
University of New Mexico Hospital
Albuquerque, New Mexico, United States, 87102
Actively Recruiting
21
Geisinger Medical Center
Danville, Pennsylvania, United States, 17822
Not Yet Recruiting
22
Bellaire Dermatology Associates Bda
Bellaire, Texas, United States, 77401
Actively Recruiting
23
Texas Dermatology Research Center
Dallas, Texas, United States, 75246
Actively Recruiting
24
3A Research Llc West Location
El Paso, Texas, United States, 79902
Not Yet Recruiting
25
Jordan Valley Dermatology Center
South Jordan, Utah, United States, 84095
Actively Recruiting
26
Dermcare Clinic
Mississauga, Ontario, Canada, L4W 0C2
Actively Recruiting
27
York Dermatology Center
Richmond Hill, Ontario, Canada, L4B 1L1
Actively Recruiting
28
The Hospital For Sick Children
Toronto, Ontario, Canada, M5G 1X8
Actively Recruiting
29
Skincare Studio Dermatology Centre
St. John's, Canada, A1E 1V4
Actively Recruiting
Research Team
I
Incyte Corporation Call Center (US)
I
Incyte Corporation Call Center (ex-US)
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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