The purpose of this study is to evaluate the efficacy and safety of ruxolitinib cream in participants with hidradenitis suppurativa.
Diagnosis of HS for at least 6 months prior to screening visit.
A total AN count of at least 4, with no draining tunnels AND
Affecting at least 2 distinct anatomical areas
Agreement to NOT use topical and systemic antibiotics for treatment of HS during the vehicle-controlled period.
Body surface areas to be treated exceed 20% BSA at screening or baseline
Presence of draining tunnels at screening or baseline.
Medical history including 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 criteria.
Parallel
Ruxolitinib Cream
DrugRuxolitinib cream applied topically to the affected area as a thin film twice daily.
Vehicle Cream
DrugMatching vehicle cream applied topically to the affected area as a thin film twice daily.
Proportion of participants who achieve Hidradenitis Suppurativa (HS) Clinical Response 75 (HiSCR75) from baseline
HiSCR75 is defined as at least a 75% reduction from baseline in the total abscess and/or inflammatory nodule (AN) count with no increase from baseline in abscess or draining tunnel count.
Proportion of participants with ≥ 1 flare
Defined as a ≥ 25% increase in AN count with a minimum increase in total AN count of 2 relative to baseline.
Proportion of participants who achieve HiSCR50
Defined as a ≥ 50 reduction from baseline in total AN count with no increase from baseline in abscess or draining tunnel count.
Proportion of participants who achieve Skin Pain Numeric Rating Scale (NRS)3 among participants with baseline Skin Pain NRS score ≥ 3
Participants with a Skin Pain score of at least 3 at baseline and who achieve Skin Pain NRS3, defined as at least 3-unit reduction from baseline in the Skin Pain NRS.
Treatment-IR Population: Proportion of participants who achieve Hidradenitis Suppurativa Clinical Response 75 (HiSCR75) from baseline
Treatment IR-Population defined as participants who had an inadequate response, intolerance, or contraindication to prior topical or systemic medications for HS. HiSCR75 is defined as at least a 75% reduction from baseline in the total AN count with no increase from baseline in abscess or draining tunnel count.
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