Pharmacokinetics, Safety, and Efficacy of Povorcitinib in Adolescent Participants With Moderate to Severe Hidradenitis Suppurativa
- Conditions
- Hidradenitis Suppurativa (HS)
- Interventions
- Registration Number
- NCT07213973
- Lead Sponsor
- Incyte Corporation
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 40
- 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.
- 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
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Povorcitinib Dose A Povorcitinib Participants will receive povorcitinib dose A for 54 weeks. Povorcitinib Dose B Povorcitinib Participants will receive povorcitinib dose B for 54 weeks.
- Primary Outcome Measures
Name Time Method Proportion of participants with Treatment-Emergent Adverse Events (TEAEs) 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 clearance Up to Week 24 Apparent volume of distribution Up to Week 24 Apparent oral absorption rate constant Up to Week 24 Absorption lag time Up to Week 24 Maximum plasma drug concentration at steady state Up to Week 24 Average plasma drug concentration at steady state Up to Week 24 Plasma concentration at steady state for the dosing interval Up to Week 24 Time to maximum plasma concentration at steady state Up to Week 24 Terminal half-life Up to Week 24
- Secondary Outcome Measures
Name Time Method Proportion of participants who achieve Hidradenitis Suppurativa Clinical Response 50 (HiSCR50) 54 weeks HiSCR50 is defined as at least a 50% reduction from baseline in the total abscess and inflammatory nodule count, with no increase from baseline in abscess or draining tunnel count.
Proportion of participants who achieve Hidradenitis Suppurativa Clinical Response 75 (HiSCR75) 54 weeks HiSCR75 is defined as at least a 75% reduction from baseline in the total abscess and inflammatory nodule count, with no increase from baseline in abscess or draining tunnel count.
Mean change from baseline in abscess count at each visit 54 weeks Defined as mean change of abscess count relative to baseline.
Mean percentage change from baseline in abscess count at each visit 54 weeks Defined as mean percentage change from baseline in abscess count.
Mean change from baseline in inflammatory nodule count at each visit 54 weeks Defined as mean change of inflammatory nodule count relative to baseline.
Mean percentage change from baseline in inflammatory nodule count at each visit 54 weeks Defined as mean percentage change from baseline in inflammatory nodule count.
Mean change from baseline in draining tunnel count at each visit 54 weeks Defined as mean change of draining tunnel count relative to baseline.
Mean percentage change from baseline in draining tunnel count at each visit 54 weeks Defined as mean percentage change from baseline in draining tunnel count.
Proportion of participants who achieve Skin Pain Numeric Rating Scale (NRS)30 among participants with baseline Skin Pain NRS score ≥ 3 54 weeks Defined as participants with a Skin Pain NRS score of at least 3 at baseline and who achieve Skin Pain NRS30, defined as at least a 30% reduction and at least 1-unit reduction from baseline in the Skin Pain NRS.
Proportion of participants with a ≥ 3-point decrease in Skin Pain NRS score at Week 12 among participants with baseline Skin Pain NRS score ≥ 3 54 weeks Participants with a Skin Pain score of at least 3 at baseline and who experience at least a 3-point decrease in Skin Pain score.
Change from baseline in Children's Dermatology Life Quality Index (CDLQI) score at each visit 54 weeks The CDLQI is a simple, 10-question validated questionnaire to measure how much the skin problem has affected the participant over the previous 7 days, across symptoms and feelings, leisure, school or holidays, personal relationships, sleep, and treatment.