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

NCT07213973 | Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: INCB054707-211
• Study Type: interventional
• Target: 40
• Locations: 2 countries
• Sites: 27

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)

Keywords

Hidradenitis Suppurativa; HS; INCB054707; Povorcitinib; Acne inversa; Hidradenitis

Outcome Measures

Primary Outcomes (10)

• Proportion of participants with Treatment-Emergent Adverse Events (TEAEs)

  TEAE is defined as any AE either reported for the first time or worsening of a pre-existing event after the first dose of study drug up to 30 days after the last dose of study drug.

  Baseline through Week 54

• Apparent clearance

  Up to Week 24

• Apparent volume of distribution

  Up to Week 24

• Apparent oral absorption rate constant

  Up to Week 24

• Absorption lag time

  Up to Week 24

• Maximum plasma drug concentration at steady state

  Up to Week 24

• Average plasma drug concentration at steady state

  Up to Week 24

• Plasma concentration at steady state for the dosing interval

  Up to Week 24

• Time to maximum plasma concentration at steady state

  Up to Week 24

• Terminal half-life

  Up to Week 24

Secondary Outcomes (11)

• Proportion of participants who achieve Hidradenitis Suppurativa Clinical Response 50 (HiSCR50)

  54 weeks

• Proportion of participants who achieve Hidradenitis Suppurativa Clinical Response 75 (HiSCR75)

  54 weeks

• Mean change from baseline in abscess count at each visit

  54 weeks

• Mean percentage change from baseline in abscess count at each visit

  54 weeks

• Mean change from baseline in inflammatory nodule count at each visit

  54 weeks

Study Arms (2)

Povorcitinib Dose A

EXPERIMENTAL

Participants will receive povorcitinib dose A for 54 weeks.

Drug: Povorcitinib

Povorcitinib Dose B

EXPERIMENTAL

Participants will receive povorcitinib dose B for 54 weeks.

Drug: Povorcitinib

Interventions

Povorcitinib DRUG

Oral; Tablet

Also known as: INCB054707

Povorcitinib Dose A; Povorcitinib Dose B

Eligibility Criteria

• Age: 12 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You 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 may not qualify 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.

Sponsors & Collaborators

• Incyte Corporation: lead

Study Sites (27)

University of Alabama At Birmingham

Birmingham, Alabama, 35233, United States

NOT YET RECRUITING

Medical Dermatology Specialists Phoenix

Phoenix, Arizona, 85006, United States

RECRUITING

Saguaro Dermatology

Phoenix, Arizona, 85008, United States

RECRUITING

Uconn Health

Farmington, Connecticut, 06030, United States

NOT YET RECRUITING

University of Miami Miller School of Medicine

Miami, Florida, 33136, United States

NOT YET RECRUITING

Skin Research of South Florida, Llc

Miami, Florida, 33173, United States

RECRUITING

Trueblue Clinical Research

Tampa, Florida, 33609, United States

RECRUITING

Advanced Medical Research Pc

Sandy Springs, Georgia, 30328, United States

RECRUITING

Endeavor Health Medical Group

Skokie, Illinois, 60077, United States

RECRUITING

Dermatology Skin Cancer Center Leawood

Leawood, Kansas, 66211, United States

RECRUITING

Equity Medical

Bowling Green, Kentucky, 42104, United States

RECRUITING

Johns Hopkins Oncology Center

Baltimore, Maryland, 21287, United States

NOT YET RECRUITING

Boston Childrens Hospital

Boston, Massachusetts, 02115, United States

NOT YET RECRUITING

Oakland Hills Dermatology Pc

Auburn Hills, Michigan, 48326, United States

RECRUITING

Wayne State University Physician Group Dermatology

Detroit, Michigan, 48201, United States

RECRUITING

Revival Research Institute, Llc Troy

Troy, Michigan, 48084, United States

RECRUITING

Washington University

St Louis, Missouri, 63110, United States

RECRUITING

Boeson Research Missoula 2825 Fort Missoula Rd

Missoula, Montana, 59804, United States

RECRUITING

University of New Mexico Hospital

Albuquerque, New Mexico, 87102, United States

RECRUITING

Geisinger Medical Center

Danville, Pennsylvania, 17822, United States

NOT YET RECRUITING

Bellaire Dermatology Associates Bda

Bellaire, Texas, 77401, United States

RECRUITING

Texas Dermatology Research Center

Dallas, Texas, 75246, United States

RECRUITING

Jordan Valley Dermatology Center

South Jordan, Utah, 84095, United States

RECRUITING

Dermcare Clinic

Mississauga, Ontario, L4W 0C2, Canada

RECRUITING

York Dermatology Center

Richmond Hill, Ontario, L4B 1L1, Canada

RECRUITING

The Hospital For Sick Children

Toronto, Ontario, M5G 1X8, Canada

NOT YET RECRUITING

Skincare Studio Dermatology Centre

St. John's, A1E 1V4, Canada

NOT YET RECRUITING

Related Links

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

MeSH Terms

Conditions

Hidradenitis Suppurativa; Hidradenitis

Condition Hierarchy (Ancestors)

Skin Diseases, Bacterial; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Skin Diseases, Infectious; Suppuration; Skin Diseases; Skin and Connective Tissue Diseases; Sweat Gland Diseases

Study Officials

• Incyte Medical Monitor

  Incyte Corporation

  STUDY DIRECTOR

Central Study Contacts

Incyte Corporation Call Center (US)

CONTACT

1.855.463.3463; medinfo@incyte.com

Incyte Corporation Call Center (ex-US)

CONTACT

+800 00027423; eumedinfo@incyte.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 7, 2025
• First Posted: October 9, 2025
• Study Start: February 2, 2026
• Primary Completion (Estimated): March 25, 2028
• Study Completion (Estimated): March 25, 2028
• Last Updated: March 20, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Data will be shared after the primary publication or 2 years after the study has ended for market authorized products and indications.
• Access Criteria: Data from eligible studies will be shared with qualified researchers according to the criteria and process described in the Data Sharing section of the www.incyteclinicaltrials.com website. For approved requests, the researchers will be granted access to anonymized data under the terms of a data sharing agreement.

Locations

CA (4); US (23)