Spyre Therapeutics, Inc.
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.
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 suppurat…
Solution for SC injection
Matching placebo for SC injection
Advanced standard of care