A Study of SPY072 in Adults With Moderate to Severe Hidradenitis Suppurativa (The SKYLIGHT Trial)

This Phase 2 study will test whether the investigational medicine, SPY072, improves hidradenitis suppurativa (HS) in adults with moderate to severe disease receiving advanced standard of care treatment. About 150 participants will be assigned by chance to receive either SPY072 or placebo for 16 weeks. Participants will be followed after the treatment period to evaluate safety and how long treatment effects may last.

Inclusion Criteria: * Clinical diagnosis of Hidradenitis Suppurativa with symptoms for at least 6 months before screening. * Hidradenitis suppurativa lesions in at least 2 distinct anatomical areas, with at least 1 area meeting Hurley Stage II or III criteria at screening and Day 1. * Total abscess and/or inflammatory nodule count of at least 5 at screening and Day 1. * Documented inadequate response, intolerance, or contraindication to at least 1 systemic therapy for hidradenitis suppurativa. Exclusion Criteria: * More than 20 draining tunnels at screening or Day 1. * Hidradenitis suppurativa lesion expected to require incision and drainage within 4 weeks before Day 1, or major hidradenitis suppurativa surgery within 12 weeks before Day 1. * Another inflammatory or skin condition that could interfere with assessment of hidradenitis suppurativa.