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

NCT ID: NCT07213973

Last Updated: 2025-12-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

PHASE2

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-12-14

Study Completion Date

2028-03-25

Brief Summary

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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.

Detailed Description

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Conditions

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Hidradenitis Suppurativa (HS)

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Povorcitinib Dose A

Participants will receive povorcitinib dose A for 54 weeks.

Group Type EXPERIMENTAL

Povorcitinib

Intervention Type DRUG

Oral; Tablet

Povorcitinib Dose B

Participants will receive povorcitinib dose B for 54 weeks.

Group Type EXPERIMENTAL

Povorcitinib

Intervention Type DRUG

Oral; Tablet

Interventions

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Povorcitinib

Oral; Tablet

Intervention Type DRUG

Other Intervention Names

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INCB054707

Eligibility Criteria

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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.

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.
Minimum Eligible Age

12 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Incyte Corporation

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Incyte Medical Monitor

Role: STUDY_DIRECTOR

Incyte Corporation

Locations

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University of Alabama At Birmingham

Birmingham, Alabama, United States

Site Status

Medical Dermatology Specialists Phoenix

Phoenix, Arizona, United States

Site Status

Saguaro Dermatology

Phoenix, Arizona, United States

Site Status

Rady Children'S Hospital-San Diego

San Diego, California, United States

Site Status

University of Miami Miller School of Medicine

Miami, Florida, United States

Site Status

Skin Research of South Florida, Llc

Miami, Florida, United States

Site Status

Trueblue Clinical Research

Tampa, Florida, United States

Site Status

Marietta Dermatology the Skin Cancer Center Marietta

Marietta, Georgia, United States

Site Status

Advanced Medical Research Pc

Sandy Springs, Georgia, United States

Site Status

Endeavor Health Medical Group

Skokie, Illinois, United States

Site Status

Dermatology Skin Cancer Center Leawood

Leawood, Kansas, United States

Site Status

Equity Medical

Bowling Green, Kentucky, United States

Site Status

Johns Hopkins Oncology Center

Baltimore, Maryland, United States

Site Status

Kindred Hair and Skin Center

Marriottsville, Maryland, United States

Site Status

Boston Childrens Hospital

Boston, Massachusetts, United States

Site Status

Oakland Hills Dermatology Pc

Auburn Hills, Michigan, United States

Site Status

Wayne State University Physician Group Dermatology

Dearborn, Michigan, United States

Site Status

Revival Research Institute, Llc Troy

Troy, Michigan, United States

Site Status

Washington University

St Louis, Missouri, United States

Site Status

Boeson Research Missoula 2825 Fort Missoula Rd

Missoula, Montana, United States

Site Status

University of New Mexico Hospital

Albuquerque, New Mexico, United States

Site Status

Geisinger Medical Center

Danville, Pennsylvania, United States

Site Status

Bellaire Dermatology Associates Bda

Bellaire, Texas, United States

Site Status

Acrc Trials/Innovative Dermatology

Plano, Texas, United States

Site Status

Texas Dermatology Research Center

Plano, Texas, United States

Site Status

Beacon Dermatology

Calgary, Alberta, Canada

Site Status

Dermcare Clinic

Mississauga, Ontario, Canada

Site Status

York Dermatology Center

Richmond Hill, Ontario, Canada

Site Status

The Hospital For Sick Children

Toronto, Ontario, Canada

Site Status

Skincare Studio Dermatology Centre

St. John's, , Canada

Site Status

Countries

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United States Canada

Central Contacts

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Incyte Corporation Call Center (US)

Role: CONTACT

1.855.463.3463

Incyte Corporation Call Center (ex-US)

Role: CONTACT

+800 00027423

Related Links

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https://incyteclinicaltrials.com/studies/nct07213973

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

Other Identifiers

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INCB054707-211

Identifier Type: -

Identifier Source: org_study_id

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