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

Part of paid clinical trials in Irvine, California.

Sponsor
Spyre Therapeutics, Inc.
Study ID
NCT07766005
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

  • Hidradenitis Suppurativa (HS)

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • SPY072 — DRUG
    Solution for SC injection
  • Placebo — DRUG
    Matching placebo for SC injection
  • bimekizumab — DRUG
    Advanced standard of care

Study Details

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.

Key Dates

First listed
Aug 14, 2026
Start date
Sep 30, 2026
Status verified
Aug 2026
Primary completion
Oct 31, 2027
Completion
Jun 30, 2028

Study Design

Enrollment
150 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: SPY072 + bimekizumab
    Participants receive SPY072 + bimekizumab
  • Placebo Comparator: Placebo + bimekizumab
    Participants receive matching placebo for SPY072 + bimekizumab

Primary Outcome Measure

Percentage of Participants Achieving Hidradenitis Suppurativa Clinical Response 75 (HiSCR75) [ Time Frame: Week 16 ]

Central Contacts

Locations (12)

FacilityCityStateZIPSite coordinators
Site 111IrvineCalifornia92614
SKYLIGHT Trial Center
Site 101IndianapolisIndiana46250
SKYLIGHT Trial Center
Site 100Bowling GreenKentucky42104
SKYLIGHT Trial Center
Site 108Baton RougeLouisiana70809
SKYLIGHT Trial Center
Site 110New OrleansLouisiana70115
SKYLIGHT Trial Center
Site 103BostonMassachusetts02115
SKYLIGHT Trial Center
Site 102New YorkNew York10023
SKYLIGHT Trial Center
Site 104The BronxNew York10455
SKYLIGHT Trial Center
Site 109Mt. PleasantSouth Carolina29464
SKYLIGHT Trial Center
Site 105DallasTexas75246
SKYLIGHT Trial Center
Site 107TylerTexas75703
SKYLIGHT Trial Center
Site 106Mill CreekWashington98012
SKYLIGHT Trial Center

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