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Recruiting NCT07213973

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

Phase II Interventional Hidradenitis Suppurativa (HS)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Povorcitinib.
Who it may be relevant to
Registry conditions: Hidradenitis Suppurativa (HS). Basic parameters: 12 years — 17 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States, Canada
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

A Phase 2, Open-Label Study to Evaluate the Safety, Pharmacokinetics, and Efficacy of Povorcitinib in Adolescents With Moderate to Severe Hidradenitis Suppurativa

Overview

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.

Interventions

  • Drug Povorcitinib
    Oral; Tablet

Primary outcome measures

  • 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]
Secondary outcome measures (11)
  • Proportion of participants who achieve Hidradenitis Suppurativa Clinical Response 50 (HiSCR50) [Time frame: 54 weeks]
  • Proportion of participants who achieve Hidradenitis Suppurativa Clinical Response 75 (HiSCR75) [Time frame: 54 weeks]
  • Mean change from baseline in abscess count at each visit [Time frame: 54 weeks]
  • Mean percentage change from baseline in abscess count at each visit [Time frame: 54 weeks]
  • Mean change from baseline in inflammatory nodule count at each visit [Time frame: 54 weeks]
  • Mean percentage change from baseline in inflammatory nodule count at each visit [Time frame: 54 weeks]
  • Mean change from baseline in draining tunnel count at each visit [Time frame: 54 weeks]
  • Mean percentage change from baseline in draining tunnel count at each visit [Time frame: 54 weeks]
  • Proportion of participants who achieve Skin Pain Numeric Rating Scale (NRS)30 among participants with baseline Skin Pain NRS score ≥ 3 [Time frame: 54 weeks]
  • Proportion of participants with a ≥ 3-point decrease in Skin Pain NRS score among participants with baseline Skin Pain NRS score ≥ 3 [Time frame: 54 weeks]
  • Change from baseline in Children's Dermatology Life Quality Index (CDLQI) score at each visit [Time frame: 54 weeks]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Non-randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 26 centers
  • University of Alabama At Birmingham — Birmingham
  • Medical Dermatology Specialists Phoenix — Phoenix
  • Saguaro Dermatology — Phoenix
  • Uconn Health — Farmington
  • University of Miami Miller School of Medicine — Miami
  • Skin Research of South Florida, Llc — Miami
  • Trueblue Clinical Research — Tampa
  • Advanced Medical Research Pc — Sandy Springs
  • … and 18 more centers
Canada · 4 centers
  • Dermcare Clinic — Mississauga
  • York Dermatology Center — Richmond Hill
  • The Hospital For Sick Children — Toronto
  • Skincare Studio Dermatology Centre — St. John's

Identifiers

NCT: NCT07213973 · INCB054707-211

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗