Recruiting
Phase 2

Povorcitinib

Sponsor:

Incyte Corporation

Code:

NCT07213973

Conditions

Hidradenitis Suppurativa (HS)

Eligibility Criteria

Sex: All

Age: 12 - 17

Healthy Volunteers: Not accepted

Interventions

Povorcitinib

Study Details

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-label treatment period.

Conditions

Hidradenitis Suppurativa (HS)

Study ID

NCT07213973

Start date

Feb 2, 2026

Status verified date

Aug, 2026

Completion date

Mar 25, 2028

Anticipated

Primary completion date

Mar 25, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 12 - 17

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

40 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Povorcitinib Dose A

Participants will receive povorcitinib dose A for 54 weeks.

experimental: Povorcitinib Dose B

Participants will receive povorcitinib dose B for 54 weeks.

Interventions

Povorcitinib

Oral; Tablet

Primary outcome measure

  • Proportion of participants with Treatment-Emergent Adverse Events (TEAEs) [ Time Frame: Baseline through Week 54 ]
  • Apparent clearance [ Time Frame: Up to Week 24 ]
  • Apparent volume of distribution [ Time Frame: Up to Week 24 ]
  • Apparent oral absorption rate constant [ Time Frame: Up to Week 24 ]
  • Absorption lag time [ Time Frame: Up to Week 24 ]
  • Maximum plasma drug concentration at steady state [ Time Frame: Up to Week 24 ]
  • Average plasma drug concentration at steady state [ Time Frame: Up to Week 24 ]
  • Plasma concentration at steady state for the dosing interval [ Time Frame: Up to Week 24 ]
  • Time to maximum plasma concentration at steady state [ Time Frame: Up to Week 24 ]
  • Terminal half-life [ Time Frame: Up to Week 24 ]

Central Contacts and Locations

Central contacts

Incyte Corporation Call Center (US)

1.855.463.3463medinfo@incyte.com

Incyte Corporation Call Center (ex-US)

+800 00027423eumedinfo@incyte.com

Locations

University of Alabama At Birmingham

Recruiting

Birmingham, Alabama, United States, 35233

Medical Dermatology Specialists Phoenix

Recruiting

Phoenix, Arizona, United States, 85006

Saguaro Dermatology

Recruiting

Phoenix, Arizona, United States, 85008

Uconn Health

Recruiting

Farmington, Connecticut, United States, 06030

University of Miami Miller School of Medicine

Recruiting

Miami, Florida, United States, 33136

Skin Research of South Florida, Llc

Recruiting

Miami, Florida, United States, 33173

Trueblue Clinical Research

Recruiting

Tampa, Florida, United States, 33607

Advanced Medical Research Pc

Recruiting

Sandy Springs, Georgia, United States, 30328

Endeavor Health Medical Group

Recruiting

Skokie, Illinois, United States, 60077

Dermatology Skin Cancer Center Leawood

Recruiting

Leawood, Kansas, United States, 66211

Equity Medical

Recruiting

Bowling Green, Kentucky, United States, 42104

Johns Hopkins Univ Schl of Medicine

Recruiting

Baltimore, Maryland, United States, 21205

Boston Childrens Hospital

Recruiting

Boston, Massachusetts, United States, 02115

Oakland Hills Dermatology Pc

Recruiting

Auburn Hills, Michigan, United States, 48326

Wayne State University Physician Group Dermatology

Recruiting

Detroit, Michigan, United States, 48201

Revival Research Institute, Llc Troy

Recruiting

Troy, Michigan, United States, 48084

Washington University

Recruiting

St Louis, Missouri, United States, 63110

Boeson Research Missoula 2825 Fort Missoula Rd

Recruiting

Missoula, Montana, United States, 59804

University of New Mexico Hospital

Recruiting

Albuquerque, New Mexico, United States, 87102

Geisinger Medical Center

Recruiting

Danville, Pennsylvania, United States, 17822

Bellaire Dermatology Associates Bda

Recruiting

Bellaire, Texas, United States, 77401

Texas Dermatology Research Center

Recruiting

Dallas, Texas, United States, 75246

Jordan Valley Dermatology Center

Recruiting

South Jordan, Utah, United States, 84095

Dermcare Clinic

Recruiting

Mississauga, Ontario, Canada, L4W 0C2

York Dermatology Center

Recruiting

Richmond Hill, Ontario, Canada, L4B 1L1

The Hospital For Sick Children

Recruiting

Toronto, Ontario, Canada, M5G 1X8

Skincare Studio Dermatology Centre

Recruiting

St. John's, Canada, A1E 1V4

More Information

Sponsor

Incyte Corporation

Last update posted

Aug 6, 2026

Last verified

Aug, 2026

Keywords

  • Hidradenitis Suppurativa
  • HS
  • INCB054707
  • Povorcitinib
  • Acne inversa
  • Hidradenitis

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Incyte Corporation on 2026-08-06.