What this study is
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.
What's being tested
- SPY072
Intervention · DRUG
Solution for SC injection
- Placebo
Intervention · DRUG
Matching placebo for SC injection
- bimekizumab
Intervention · DRUG
Advanced standard of care
Study details
- Official title
- A Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled, Proof-of-concept Trial to Assess the Efficacy and Safety of SPY072 in Adults With Moderate to Severe Hidradenitis Suppurativa Receiving Standard of Care Treatment
- Sponsor
- Spyre Therapeutics, Inc.
- Conditions
- Hidradenitis Suppurativa (HS)
- Enrolling
- 150 people
- Starts
- 2026-09
- Est. completion
- 2028-06
- Design
- Quadruple-blind, randomized, parallel groups, Phase 2
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years – 75 YearsSex ALLHealthy volunteers Not acceptedYou may qualify if
- 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.
You can't join if
- 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.
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (34)
34 openContact for every open site
- SKYLIGHT Trial Center · Contact
Site 117
Birmingham, Alabama, United States
Not yet recruitingSite 119
Rogers, Arkansas, United States
Not yet recruitingSite 111
Irvine, California, United States
Not yet recruitingSite 113
Coral Gables, Florida, United States
Not yet recruitingSite 115
Atlanta, Georgia, United States
Not yet recruitingSite 101
Indianapolis, Indiana, United States
RecruitingSite 100
Bowling Green, Kentucky, United States
RecruitingSite 116
Owensboro, Kentucky, United States
RecruitingSite 108
Baton Rouge, Louisiana, United States
Not yet recruitingSite 103
Boston, Massachusetts, United States
Not yet recruitingSite 112
Boston, Massachusetts, United States
Not yet recruitingSite 127
Detroit, Michigan, United States
Not yet recruitingSite 120
Las Vegas, Nevada, United States
Not yet recruitingSite 126
Las Vegas, Nevada, United States
Not yet recruitingSite 102
New York, New York, United States
RecruitingSite 104
The Bronx, New York, United States
RecruitingSite 124
Durham, North Carolina, United States
Not yet recruitingSite 122
Oklahoma City, Oklahoma, United States
Not yet recruitingSite 109
Mt. Pleasant, South Carolina, United States
Not yet recruitingSite 125
Nashville, Tennessee, United States
RecruitingSite 118
Smyrna, Tennessee, United States
Not yet recruitingSite 114
Prosper, Texas, United States
Not yet recruitingSite 107
Tyler, Texas, United States
RecruitingSite 121
Tyler, Texas, United States
Not yet recruitingSite 123
Murray, Utah, United States
Not yet recruitingSite 106
Mill Creek, Washington, United States
Not yet recruiting
8 sites outside the US
Site 163
Edmonton, Alberta, Canada
Not yet recruitingSite 165
Surrey, British Columbia, Canada
Not yet recruitingSite 164
Winnipeg, Manitoba, Canada
Not yet recruitingSite 160
Barrie, Ontario, Canada
Not yet recruitingSite 167
Markham, Ontario, Canada
Not yet recruitingSite 162
Richmond Hill, Ontario, Canada
Not yet recruitingSite 166
Québec, Quebec, Canada
Not yet recruitingSite 161
Saskatoon, Saskatchewan, Canada
Not yet recruiting
Study team
Sponsor
Spyre Therapeutics, Inc.
Study ID SPY002-072-202
Study director
Joshua Friedman, MD, PhD
Spyre Therapeutics, Inc.
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.