NCT07766005

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.

Trial Health

63
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P75+ for phase_2

Timeline
21mo left

Started Sep 2026

Geographic Reach
1 country

12 active sites

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 10, 2026

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 14, 2026

Completed
18 days until next milestone

Study Start

First participant enrolled

September 1, 2026

Expected
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2027

8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2028

Last Updated

August 14, 2026

Status Verified

August 1, 2026

Enrollment Period

1.1 years

First QC Date

August 10, 2026

Last Update Submit

August 10, 2026

Conditions

Hidradenitis Suppurativa (HS)

Keywords

Hidradenitis suppurativaHidradenitisSkin diseasesSweat gland diseasesSkin and connective tissue diseases

Outcome Measures

Primary Outcomes (1)

  • Percentage of Participants Achieving Hidradenitis Suppurativa Clinical Response 75 (HiSCR75)

    HiSCR75 is defined as at least a 75% reduction from baseline in total abscess and inflammatory nodule count, with no increase in abscess count and no increase in draining tunnel count

    Week 16

Secondary Outcomes (2)

  • Percentage of Participants Achieving Hidradenitis Suppurativa Clinical Response 50 (HiSCR50)

    Week 16

  • Treatment-emergent Adverse Events (TEAEs)

    Up to 52 weeks

Study Arms (2)

SPY072 + bimekizumab

EXPERIMENTAL

Participants receive SPY072 + bimekizumab

Drug: SPY072Drug: bimekizumab

Placebo + bimekizumab

PLACEBO COMPARATOR

Participants receive matching placebo for SPY072 + bimekizumab

Drug: PlaceboDrug: bimekizumab

Interventions

SPY072DRUG

Solution for SC injection

Also known as: SPY002-072
SPY072 + bimekizumab
PlaceboDRUG

Matching placebo for SC injection

Placebo + bimekizumab
bimekizumabDRUG

Advanced standard of care

Placebo + bimekizumabSPY072 + bimekizumab

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You 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 may not qualify 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (12)

Site 111

Irvine, California, 92614, United States

Location

Site 101

Indianapolis, Indiana, 46250, United States

Location

Site 100

Bowling Green, Kentucky, 42104, United States

Location

Site 108

Baton Rouge, Louisiana, 70809, United States

Location

Site 110

New Orleans, Louisiana, 70115, United States

Location

Site 103

Boston, Massachusetts, 02115, United States

Location

Site 102

New York, New York, 10023, United States

Location

Site 104

The Bronx, New York, 10455, United States

Location

Site 109

Mt. Pleasant, South Carolina, 29464, United States

Location

Site 105

Dallas, Texas, 75246, United States

Location

Site 107

Tyler, Texas, 75703, United States

Location

Site 106

Mill Creek, Washington, 98012, United States

Location

MeSH Terms

Conditions

Hidradenitis SuppurativaHidradenitisSkin DiseasesSweat Gland DiseasesSkin and Connective Tissue Diseases

Interventions

bimekizumab

Condition Hierarchy (Ancestors)

Skin Diseases, BacterialBacterial InfectionsBacterial Infections and MycosesInfectionsSkin Diseases, InfectiousSuppuration

Study Officials

  • Joshua Friedman, MD, PhD

    Spyre Therapeutics, Inc.

    STUDY DIRECTOR

Central Study Contacts

SKYLIGHT Trial Center

CONTACT

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

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Two parallel treatment arms; SPY072 or matching placebo
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 10, 2026

First Posted

August 14, 2026

Study Start (Estimated)

September 1, 2026

Primary Completion (Estimated)

October 1, 2027

Study Completion (Estimated)

June 1, 2028

Last Updated

August 14, 2026

Record last verified: 2026-08

Data Sharing

IPD Sharing
Will not share

Locations

US(12)