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

RecruitingPhase 2Ages 12 Years - 17 YearsAllIncyte Corporation
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: * Aged โ‰ฅ 12 to \< 18 years at the time of informed consent/assent signing. * Body weight โ‰ฅ 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.
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What it tests

  • Povorcitinib
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Where

30 sites
University of Alabama At Birmingham
Birmingham, United States
Medical Dermatology Specialists Phoenix
Phoenix, United States
Saguaro Dermatology
Phoenix, United States
Uconn Health
Farmington, United States
University of Miami Miller School of Medicine
Miami, United States
Skin Research of South Florida, Llc
Miami, United States
Trueblue Clinical Research
Tampa, United States
Advanced Medical Research Pc
Sandy Springs, United States

โ€ฆand 22 more on ClinicalTrials.gov.

๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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