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.
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.
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.
Parallel
Povorcitinib
DrugOral; Tablet
Proportion of participants with Treatment-Emergent Adverse Events (TEAEs)
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
Apparent volume of distribution
Apparent oral absorption rate constant
Proportion of participants who achieve Hidradenitis Suppurativa Clinical Response 50 (HiSCR50)
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)
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
Defined as mean change of abscess count relative to baseline.
Mean percentage change from baseline in abscess count at each visit
Defined as mean percentage change from baseline in abscess count.
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