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NCT07213973PHASE2Recruiting

Pharmacokinetics, Safety, and Efficacy of Povorcitinib in Adolescent Participants With Moderate to Severe Hidradenitis Suppurativa

Incyte Corporation

Start Date

2/2/2026

Completion Date

3/25/2028

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-label treatment period.

Eligibility Criteria

Age Range: 12 years to 17 years

Inclusion Criteria: * 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 Criteria: * 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.

Interventions

DRUG

Povorcitinib

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Conditions

Hidradenitis Suppurativa (HS)

Locations

University of Alabama At Birmingham

Birmingham, Alabama 35233

United States

Medical Dermatology Specialists Phoenix

Phoenix, Arizona 85006

United States

Saguaro Dermatology

Phoenix, Arizona 85008

United States

Uconn Health

Farmington, Connecticut 06030

United States

University of Miami Miller School of Medicine

Miami, Florida 33136

United States

Skin Research of South Florida, Llc

Miami, Florida 33173

United States

Trueblue Clinical Research

Tampa, Florida 33607

United States

Advanced Medical Research Pc

Sandy Springs, Georgia 30328

United States

Endeavor Health Medical Group

Skokie, Illinois 60077

United States

Dermatology Skin Cancer Center Leawood

Leawood, Kansas 66211

United States

Equity Medical

Bowling Green, Kentucky 42104

United States

Johns Hopkins Univ Schl of Medicine

Baltimore, Maryland 21205

United States

Skin Oasis Dermatology

Gambrills, Maryland 21054

United States

Boston Childrens Hospital

Boston, Massachusetts 02115

United States

Oakland Hills Dermatology Pc

Auburn Hills, Michigan 48326

United States

Wayne State University Physician Group Dermatology

Detroit, Michigan 48201

United States

Revival Research Institute, Llc Troy

Troy, Michigan 48084

United States

University of Missouri Kansas City

Kansas City, Missouri 64108

United States

Washington University

St Louis, Missouri 63110

United States

Boeson Research Missoula 2825 Fort Missoula Rd

Missoula, Montana 59804

United States

University of New Mexico Hospital

Albuquerque, New Mexico 87102

United States

Geisinger Medical Center

Danville, Pennsylvania 17822

United States

Bellaire Dermatology Associates Bda

Bellaire, Texas 77401

United States

Texas Dermatology Research Center

Dallas, Texas 75246

United States

3A Research Llc West Location

El Paso, Texas 79902

United States

Jordan Valley Dermatology Center

South Jordan, Utah 84095

United States

Dermcare Clinic

Mississauga, Ontario L4W 0C2

Canada

York Dermatology Center

Richmond Hill, Ontario L4B 1L1

Canada

The Hospital For Sick Children

Toronto, Ontario M5G 1X8

Canada

Skincare Studio Dermatology Centre

St. John's, A1E 1V4

Canada