The purpose of this study is to evaluate the maximal use of ruxolitinib cream in adult and adolescent participants with hidradenitis suppurativa.
Diagnosis of HS for at least 6 months before screening visit.
Diagnosis of HS (Hurley Stage I, II, III) with a total abscess and inflammatory nodule count of at least 4 and affecting at least 3 distinct anatomical areas at screening and Day 1 visits.
Total estimated treatment BSA > 20% at screening and baseline.
Agreement to not use topical or systemic antibiotics for treatment of HS during the Maximal Use Treatment Period.
Current or history of skin condition(s) other than HS that might confound the evaluation of HS; clinically uncontrolled cardiovascular disease; thrombosis; certain cancers; certain infections; severe anemia, thrombocytopenia, or neutropenia; other medical conditions at the discretion of the investigator.
Laboratory values outside of the protocol-defined ranges.
Further exclusion criteria apply.
Single group
Ruxolitinib Cream
DrugRuxolitinib cream applied topically to the affected area as a thin film twice daily.
Number of participants with Treatment-emergent Adverse Events (TEAEs)
Defined as adverse events reported for the first time or worsening of a pre-existing event after the first application of study drug.
Number of participants with TEAEs leading to treatment interruption, discontinuation
Number of participants with TEAEs leading to dose interruption or discontinuation
Pharmacokinetics Parameter (PK): Cmax of INCB018424
Defined as maximum observed plasma concentration of INCB018424.
Pharmacokinetics Parameter: Tmax of INCB018424
Defined as the time to reach the maximum plasma concentration of INCB018424.
Pharmacokinetics Parameter: AUC 0-12 of INCB018424
Defined as the area under the plasma or serum concentration-time curve from Hour 0 to 12 hours of INCB018424.
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