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Purpose

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.

Condition

Eligibility

Eligible Ages
Between 12 Years and 17 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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

Phase
Phase 2
Study Type
Interventional
Allocation
Non-Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Povorcitinib Dose A 		Participants will receive povorcitinib dose A for 54 weeks.
  • Drug: Povorcitinib
    Oral; Tablet
    Other names:
    • INCB054707
Experimental
Povorcitinib Dose B 		Participants will receive povorcitinib dose B for 54 weeks.
  • Drug: Povorcitinib
    Oral; Tablet
    Other names:
    • INCB054707

Recruiting Locations

Medical Dermatology Specialists Phoenix
Phoenix, Arizona 85006

Saguaro Dermatology
Phoenix, Arizona 85008

University of Miami Miller School of Medicine
Miami, Florida 33136

Skin Research of South Florida, Llc
Miami, Florida 33173

Trueblue Clinical Research
Tampa, Florida 33609

Advanced Medical Research Pc
Sandy Springs, Georgia 30328

Endeavor Health Medical Group
Skokie, Illinois 60077

Dermatology Skin Cancer Center Leawood
Leawood, Kansas 66211

Equity Medical
Bowling Green, Kentucky 42104

Johns Hopkins Oncology Center
Baltimore, Maryland 21287

Oakland Hills Dermatology Pc
Auburn Hills, Michigan 48326

Wayne State University Physician Group Dermatology
Detroit, Michigan 48201

Revival Research Institute, Llc Troy
Troy, Michigan 48084

Washington University
St Louis, Missouri 63110

Boeson Research Missoula 2825 Fort Missoula Rd
Missoula, Montana 59804

University of New Mexico Hospital
Albuquerque, New Mexico 87102

Bellaire Dermatology Associates Bda
Bellaire, Texas 77401

Texas Dermatology Research Center
Dallas, Texas 75246

Jordan Valley Dermatology Center
South Jordan, Utah 84095

More Details

Status
Recruiting
Sponsor
Incyte Corporation

Study Contact

Incyte Corporation Call Center (US)
1.855.463.3463
medinfo@incyte.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.