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

This is a multicenter, randomized, double-blind, placebo-controlled, parallel-group, proof-of-concept study of SPY072 in adults 18 to 75 years of age with moderate to severe HS who are receiving advanced standard of care treatment. After a screening period, approximately 150 eligible participants will be randomized to SPY072 or matching placebo through Week 16. After completion of treatment, participants will then enter a follow-up period.

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.