What this study is
The purpose of this study is to evaluate the pharmacokinetics, safety, and efficacy of povorcitinib in adolescent participants with moderate to severe hidradenitis suppurativa over a 54-week open-label treatment period.
What's being tested
- Povorcitinib
Intervention · DRUG
Oral; Tablet
Study details
- Official title
- A Phase 2, Open-Label Study to Evaluate the Safety, Pharmacokinetics, and Efficacy of Povorcitinib in Adolescents With Moderate to Severe Hidradenitis Suppurativa
- Sponsor
- Incyte Corporation
- Conditions
- Hidradenitis Suppurativa (HS)
- Enrolling
- 40 people
- Starts
- 2026-02-02
- Est. completion
- 2028-03-25
- Design
- Open-label, non-randomized, parallel groups, Phase 2
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 12 Years – 17 YearsSex ALLHealthy volunteers Not acceptedYou may qualify if
- Aged ≥ 12 to < 18 years at the time of informed consent/assent signing.
- Body weight ≥ 30 kg at both screening and baseline visits.
- Diagnosis of moderate to severe HS for at least 3 months prior to the screening visit.
- Total abscess and inflammatory nodule count of at least 5 at both the screening and baseline visits.
- HS lesions corresponding to refined Hurley Stage IB, IC, IIB, IIC, or III at both the screening and baseline visits.
- Documented history of inadequate response to at least a 3-month course of at least 1 conventional systemic therapy (oral antibiotic or biologic drug) for HS (or demonstrated intolerance to, or have a contraindication to, a conventional systemic therapy for treatment of their HS).
- Agreement to use contraception.
- Willing and able to comply with the study protocol and procedures.
You can't join if
- Presence of > 20 draining tunnels (fistulas) at either the screening or baseline visit.
- Women who are pregnant (or who are considering pregnancy) or breastfeeding.
- Medical history including thrombocytopenia, coagulopathy or platelet dysfunction, Q-wave interval abnormalities, current or history of certain infections, cancer, lymphoproliferative disorders and other medical conditions at the discretion of the investigator.
- Laboratory values outside of the protocol-defined ranges.
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (30)
30 openUniversity of Alabama At Birmingham
Birmingham, Alabama, United States
RecruitingMedical Dermatology Specialists Phoenix
Phoenix, Arizona, United States
RecruitingSaguaro Dermatology
Phoenix, Arizona, United States
RecruitingUconn Health
Farmington, Connecticut, United States
RecruitingUniversity of Miami Miller School of Medicine
Miami, Florida, United States
RecruitingSkin Research of South Florida, Llc
Miami, Florida, United States
RecruitingTrueblue Clinical Research
Tampa, Florida, United States
RecruitingAdvanced Medical Research Pc
Sandy Springs, Georgia, United States
RecruitingEndeavor Health Medical Group
Skokie, Illinois, United States
RecruitingDermatology Skin Cancer Center Leawood
Leawood, Kansas, United States
RecruitingEquity Medical
Bowling Green, Kentucky, United States
RecruitingJohns Hopkins Univ Schl of Medicine
Baltimore, Maryland, United States
RecruitingSkin Oasis Dermatology
Gambrills, Maryland, United States
Not yet recruitingBoston Childrens Hospital
Boston, Massachusetts, United States
RecruitingOakland Hills Dermatology Pc
Auburn Hills, Michigan, United States
RecruitingWayne State University Physician Group Dermatology
Detroit, Michigan, United States
RecruitingRevival Research Institute, Llc Troy
Troy, Michigan, United States
RecruitingUniversity of Missouri Kansas City
Kansas City, Missouri, United States
Not yet recruitingWashington University
St Louis, Missouri, United States
RecruitingBoeson Research Missoula 2825 Fort Missoula Rd
Missoula, Montana, United States
RecruitingUniversity of New Mexico Hospital
Albuquerque, New Mexico, United States
RecruitingGeisinger Medical Center
Danville, Pennsylvania, United States
RecruitingBellaire Dermatology Associates Bda
Bellaire, Texas, United States
RecruitingTexas Dermatology Research Center
Dallas, Texas, United States
Recruiting3A Research Llc West Location
El Paso, Texas, United States
RecruitingJordan Valley Dermatology Center
South Jordan, Utah, United States
Recruiting
4 sites outside the US
Dermcare Clinic
Mississauga, Ontario, Canada
RecruitingYork Dermatology Center
Richmond Hill, Ontario, Canada
RecruitingThe Hospital For Sick Children
Toronto, Ontario, Canada
RecruitingSkincare Studio Dermatology Centre
St. John's, Canada
Recruiting
Study team
Sponsor
Incyte Corporation
Study ID INCB054707-211
Study director
Incyte Medical Monitor
Incyte Corporation
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.