Status:
NOT_YET_RECRUITING
Pharmacokinetics, Safety, and Efficacy of Povorcitinib in Adolescent Participants With Moderate to Severe Hidradenitis Suppurativa
Lead Sponsor:
Incyte Corporation
Conditions:
Hidradenitis Suppurativa (HS)
Eligibility:
All Genders
12-17 years
Phase:
PHASE2
Brief Summary
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-labe...
Eligibility Criteria
Inclusion
- 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.
- Further inclusion criteria apply.
Exclusion
- 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.
- Further exclusion criteria apply.
Key Trial Info
Start Date :
December 14 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 25 2028
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT07213973
Start Date
December 14 2025
End Date
March 25 2028
Last Update
December 5 2025
Active Locations (30)
Enter a location and click search to find clinical trials sorted by distance.
1
University of Alabama At Birmingham
Birmingham, Alabama, United States, 35233
2
Medical Dermatology Specialists Phoenix
Phoenix, Arizona, United States, 85006
3
Saguaro Dermatology
Phoenix, Arizona, United States, 85008
4
Rady Children'S Hospital-San Diego
San Diego, California, United States, 92123