Recruiting
Phase 2

SPY072

Sponsor:

Spyre Therapeutics, Inc.

Code:

NCT07766005

Conditions

Hidradenitis Suppurativa (HS)

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

SPY072

Placebo

bimekizumab

Study Details

Brief summary:

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.

Conditions

Hidradenitis Suppurativa (HS)

Study ID

NCT07766005

Start date

Sep, 2026

Status verified date

Oct, 2026

Completion date

Jun, 2028

Anticipated

Primary completion date

Oct, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

150 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: SPY072 + bimekizumab

Participants receive SPY072 + bimekizumab

placebo comparator: Placebo + bimekizumab

Participants receive matching placebo for SPY072 + bimekizumab

Interventions

SPY072

Solution for SC injection

Placebo

Matching placebo for SC injection

bimekizumab

Advanced standard of care

Primary outcome measure

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

Central Contacts and Locations

Central contacts

SKYLIGHT Trial Center

1-702-602-7976info@SKYLIGHT-trial.com

Locations

Site 101

Recruiting

Indianapolis, Indiana, United States, 46250

Site 100

Recruiting

Bowling Green, Kentucky, United States, 42104

Site 116

Recruiting

Owensboro, Kentucky, United States, 42303

Site 102

Recruiting

New York, New York, United States, 10023

Site 104

Recruiting

The Bronx, New York, United States, 10455

Site 125

Recruiting

Nashville, Tennessee, United States, 37211

Site 107

Recruiting

Tyler, Texas, United States, 75703

More Information

Sponsor

Spyre Therapeutics, Inc.

Last update posted

Oct 19, 2026

Last verified

Oct, 2026

Keywords

  • Hidradenitis suppurativa
  • Hidradenitis
  • Skin diseases
  • Sweat gland diseases
  • Skin and connective tissue diseases

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-20. This information was provided to ClinicalTrials.gov by Spyre Therapeutics, Inc. on 2026-10-19. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.