NCT07213973RecruitingPhase 2
A Phase 2, Open-Label Study to Evaluate the Safety, Pharmacokinetics, and Efficacy of Povorcitinib in Adolescents With Moderate to Severe Hidradenitis Suppurativa
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 2
- Status
- Recruiting
- Sponsor
- Incyte Corporation
- Enrollment
- 40
- Locations
- 51
- Primary Endpoint
- Apparent clearance
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 12 Years to 17 Years (Child)
- 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.
Arms & Interventions
Povorcitinib Dose B
Experimental
Participants will receive povorcitinib dose B for 54 weeks.
Intervention: Povorcitinib (Drug)
Povorcitinib Dose A
Experimental
Participants will receive povorcitinib dose A for 54 weeks.
Intervention: Povorcitinib (Drug)
Outcomes
Primary Outcomes
Apparent clearance
Time Frame: Up to Week 24
Absorption lag time
Time Frame: Up to Week 24
Proportion of participants with Treatment-Emergent Adverse Events (TEAEs)
Time Frame: Baseline through Week 54
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.
Apparent volume of distribution
Time Frame: Up to Week 24
Apparent oral absorption rate constant
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 Outcomes
- Mean change from baseline in inflammatory nodule count at each visit(54 weeks)
- Mean percentage change from baseline in inflammatory nodule count at each visit(54 weeks)
- Mean change from baseline in draining tunnel count at each visit(54 weeks)
- Mean percentage change from baseline in draining tunnel count at each visit(54 weeks)
- Proportion of participants who achieve Skin Pain Numeric Rating Scale (NRS)30 among participants with baseline Skin Pain NRS score ≥ 3(54 weeks)
- Change from baseline in Children's Dermatology Life Quality Index (CDLQI) score at each visit(54 weeks)
- 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)
- 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)
- Mean percentage change from baseline in inflammatory nodule count at each visit(54 weeks)
- Mean change from baseline in draining tunnel count at each visit(54 weeks)
- Mean percentage change from baseline in draining tunnel count at each visit(54 weeks)
- Proportion of participants who achieve Skin Pain Numeric Rating Scale (NRS)30 among participants with baseline Skin Pain NRS score ≥ 3(54 weeks)
- Proportion of participants with a ≥ 3-point decrease in Skin Pain NRS score among participants with baseline Skin Pain NRS score ≥ 3(54 weeks)
- Change from baseline in Children's Dermatology Life Quality Index (CDLQI) score at each visit(54 weeks)
Investigators
Study Sites (51)
Loading locations...
Similar Trials
Terminated
Phase 2
Study of Proxinium for Treating Patients With Squamous Cell Head and Neck CancerSquamous Cell Carcinoma of the Head and NeckHead and Neck CancerCarcinoma, Squamous CellMouth NeoplasmsNeoplasms, Squamous CellHead and Neck NeoplasmsNCT00272181Sesen Bio, Inc.15
Completed
Phase 1
A Study to Evaluate the Drug Interaction Between Povorcitinib and the Oral Contraceptive Levonorgestrel/Ethinyl Estradiol in Healthy Adult FemalesHealthy ParticipantsNCT06380205Incyte Corporation24
Active, not recruiting
Phase 2
To Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of KP104Paroxysmal Nocturnal HemoglobinuriaNCT05476887Kira Pharmacenticals (US), LLC.35
Completed
Phase 2
A Study to Evaluate Oral VT-464 in Patients With Castration-Resistant Prostate CancerCastration-resistant Prostate CancerCRPCNCT02012920Innocrin Pharmaceutical200
Active, not recruiting
Phase 3
A Study to Evaluate Efficacy and Safety of Povorcitinib in Participants With Nonsegmental Vitiligo (STOP-V2)NonSegmental VitiligoNCT06113471Incyte Corporation450