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RECRUITING Phase 2 ClinicalTrials.gov

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

Sponsor: Spyre Therapeutics, Inc. • ClinicalTrials.gov ID: NCT07766005

Registry updated: 2026-10-19
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Description

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.

Interventions

  • SPY072 (Drug)
    Solution for SC injection
  • Placebo (Drug)
    Matching placebo for SC injection
  • bimekizumab (Drug)
    Advanced standard of care

Eligibility criteria

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.

Conditions

Hidradenitis Suppurativa (HS)

Locations

  • Site 117 — Birmingham, Alabama, United States
  • Site 119 — Rogers, Arkansas, United States
  • Site 111 — Irvine, California, United States
  • Site 113 — Coral Gables, Florida, United States
  • Site 115 — Atlanta, Georgia, United States
  • Site 101 — Indianapolis, Indiana, United States
  • Site 100 — Bowling Green, Kentucky, United States
  • Site 116 — Owensboro, Kentucky, United States
  • Site 108 — Baton Rouge, Louisiana, United States
  • Site 103 — Boston, Massachusetts, United States
  • Site 112 — Boston, Massachusetts, United States
  • Site 127 — Detroit, Michigan, United States
  • Site 120 — Las Vegas, Nevada, United States
  • Site 126 — Las Vegas, Nevada, United States
  • Site 102 — New York, New York, United States
  • Site 104 — The Bronx, New York, United States
  • Site 124 — Durham, North Carolina, United States
  • Site 122 — Oklahoma City, Oklahoma, United States
  • Site 109 — Mt. Pleasant, South Carolina, United States
  • Site 125 — Nashville, Tennessee, United States
  • Site 118 — Smyrna, Tennessee, United States
  • Site 114 — Prosper, Texas, United States
  • Site 107 — Tyler, Texas, United States
  • Site 121 — Tyler, Texas, United States
  • Site 123 — Murray, Utah, United States
  • Site 106 — Mill Creek, Washington, United States
  • Site 163 — Edmonton, Alberta, Canada
  • Site 165 — Surrey, British Columbia, Canada
  • Site 164 — Winnipeg, Manitoba, Canada
  • Site 160 — Barrie, Ontario, Canada
  • Site 167 — Markham, Ontario, Canada
  • Site 162 — Richmond Hill, Ontario, Canada
  • Site 166 — Québec, Quebec, Canada
  • Site 161 — Saskatoon, Saskatchewan, Canada
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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record