ClinicalTrials.gg
RecruitingNCT07766005Updated Oct 19, 2026

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

A Phase 2 interventional study of SPY072 and Placebo in Hidradenitis Suppurativa (HS), sponsored by Spyre Therapeutics, Inc.. Recruiting at 34 sites in 2 countries. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-10-19.

Sponsored by Spyre Therapeutics, Inc. · Phase 2, Interventional, and Treatment

Updated Oct 19, 2026Now RecruitingFirst site in Canada+3 moreGo to Updates ↓
Phase
Phase 2
Study type
Interventional
Enrollment
150
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
All
01

Study 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.

Read the detailed description

This is a multicenter, randomized, double-blind, placebo-controlled, parallel-group, proof-of-concept study of SPY072 in adults 18 to 75 years of age with moderate to severe HS who are receiving advanced standard of care treatment. After a screening period, approximately 150 eligible participants will be randomized to SPY072 or matching placebo through Week 16. After completion of treatment, participants will then enter a follow-up period.

02

Conditions studied

  • Hidradenitis Suppurativa (HS)

Keywords

  • Hidradenitis suppurativa
  • Hidradenitis
  • Skin diseases
  • Sweat gland diseases
  • Skin and connective tissue diseases
03

In context

Hidradenitis Suppurativa

284 studies on the registry are indexed under Hidradenitis Suppurativa; 87 are open to participants now.

This study's planned enrollment of 150 is above the median of 45 across 199 interventional studies indexed under Hidradenitis Suppurativa.

Browse Hidradenitis Suppurativa studies →

Lead sponsor

Spyre Therapeutics, Inc. is the lead sponsor of 8 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 to at least 1 systemic therapy for hidradenitis suppurativa.

Exclusion criteria

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.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
150 participants (estimated)

Study arms

  • Experimental
    SPY072 + bimekizumab

    Participants receive SPY072 + bimekizumab

    Drug: SPY072 · Drug: bimekizumab

  • Placebo comparator
    Placebo + bimekizumab

    Participants receive matching placebo for SPY072 + bimekizumab

    Drug: Placebo · Drug: bimekizumab

Interventions

  • DrugSPY072

    Solution for SC injection

    Also known as: SPY002-072

  • DrugPlacebo

    Matching placebo for SC injection

  • Advanced standard of care

06

What researchers measure

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

    Time frame: Week 16

Secondary outcomes

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

    HiSCR50 is defined as at least a 50% reduction from baseline in total abscess and inflammatory nodule count, with no increase in abscess count and no increase in draining tunnel count.

    Time frame: Week 16

  2. Treatment-emergent Adverse Events (TEAEs)

    Incidence, severity and causal relationship of TEAEs

    Time frame: Up to 52 weeks

07

Study locations

7 of 34 sites recruiting
  • Site 117
    Birmingham, Alabama 35244, United States
    Not yet recruiting
    • SKYLIGHT Trial Center · Contact
  • Site 119
    Rogers, Arkansas 72758, United States
    Not yet recruiting
    • SKYLIGHT Trial Center · Contact
  • Site 111
    Irvine, California 92614, United States
    Not yet recruiting
    • SKYLIGHT Trial Center · Contact
  • Site 113
    Coral Gables, Florida 33134, United States
    Not yet recruiting
    • SKYLIGHT Trial Center · Contact
  • Site 115
    Atlanta, Georgia 30329, United States
    Not yet recruiting
    • SKYLIGHT Trial Center · Contact
  • Site 101
    Indianapolis, Indiana 46250, United States
    Recruiting
    • SKYLIGHT Trial Center · Contact
  • Site 100
    Bowling Green, Kentucky 42104, United States
    Recruiting
    • SKYLIGHT Trial Center · Contact
  • Site 116
    Owensboro, Kentucky 42303, United States
    Recruiting
    • SKYLIGHT Trial Center · Contact
  • Site 108
    Baton Rouge, Louisiana 70809, United States
    Not yet recruiting
    • SKYLIGHT Trial Center · Contact
  • Site 103
    Boston, Massachusetts 02115, United States
    Not yet recruiting
    • SKYLIGHT Trial Center · Contact
  • Site 112
    Boston, Massachusetts 02115, United States
    Not yet recruiting
    • SKYLIGHT Trial Center · Contact
  • Site 127
    Detroit, Michigan 48202, United States
    Not yet recruiting
    • SKYLIGHT Trial Center · Contact
  • Site 120
    Las Vegas, Nevada 89119, United States
    Not yet recruiting
    • SKYLIGHT Trial Center · Contact
  • Site 126
    Las Vegas, Nevada 89145, United States
    Not yet recruiting
    • SKYLIGHT Trial Center · Contact
  • Site 102
    New York, New York 10023, United States
    Recruiting
    • SKYLIGHT Trial Center · Contact
  • Site 104
    The Bronx, New York 10455, United States
    Recruiting
    • SKYLIGHT Trial Center · Contact
  • Site 124
    Durham, North Carolina 27710, United States
    Not yet recruiting
    • SKYLIGHT Trial Center · Contact
  • Site 122
    Oklahoma City, Oklahoma 73118, United States
    Not yet recruiting
    • SKYLIGHT Trial Center · Contact
  • Site 109
    Mt. Pleasant, South Carolina 29464, United States
    Not yet recruiting
    • SKYLIGHT Trial Center · Contact
  • Site 125
    Nashville, Tennessee 37211, United States
    Recruiting
    • SKYLIGHT Trial Center · Contact
  • Site 118
    Smyrna, Tennessee 37617, United States
    Not yet recruiting
    • SKYLIGHT Trial Center · Contact
  • Site 114
    Prosper, Texas 75078, United States
    Not yet recruiting
    • SKYLIGHT Trial Center · Contact
  • Site 107
    Tyler, Texas 75703, United States
    Recruiting
    • SKYLIGHT Trial Center · Contact
  • Site 121
    Tyler, Texas 75703, United States
    Not yet recruiting
    • SKYLIGHT Trial Center · Contact
  • Site 123
    Murray, Utah 84107, United States
    Not yet recruiting
    • SKYLIGHT Trial Center · Contact
  • Site 106
    Mill Creek, Washington 98012, United States
    Not yet recruiting
    • SKYLIGHT Trial Center · Contact
  • Site 163
    Edmonton, Alberta T6G 1C3, Canada
    Not yet recruiting
    • SKYLIGHT Trial Center · Contact
  • Site 165
    Surrey, British Columbia V3V 0C6, Canada
    Not yet recruiting
    • SKYLIGHT Trial Center · Contact
  • Site 164
    Winnipeg, Manitoba R3M 3Z4, Canada
    Not yet recruiting
    • SKYLIGHT Trial Center · Contact
  • Site 160
    Barrie, Ontario L4M 7G1, Canada
    Not yet recruiting
    • SKYLIGHT Trial Center · Contact
  • Site 167
    Markham, Ontario L3P 1X2, Canada
    Not yet recruiting
    • SKYLIGHT Trial Center · Contact
  • Site 162
    Richmond Hill, Ontario L4B 1A5, Canada
    Not yet recruiting
    • SKYLIGHT Trial Center · Contact
  • Site 166
    Québec, Quebec G1M 2S8, Canada
    Not yet recruiting
    • SKYLIGHT Trial Center · Contact
  • Site 161
    Saskatoon, Saskatchewan S7T 0G3, Canada
    Not yet recruiting
    • SKYLIGHT Trial Center · Contact
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

1 registry update since Sep 25, 2026
Status
Not yet recruiting→Recruiting
changed Oct 19, 2026
Sites
24 sites added, 2 sites removed — first site in Canada. 10 sites changed recruiting status (5 now not yet recruiting, 5 now recruiting)
Show 10 sites
  • Site 111 · Irvine, United Statesno status→Not yet recruiting
  • Site 101 · Indianapolis, United Statesno status→Recruiting
  • Site 100 · Bowling Green, United Statesno status→Recruiting
  • Site 108 · Baton Rouge, United Statesno status→Not yet recruiting
  • Site 103 · Boston, United Statesno status→Not yet recruiting
  • Site 102 · New York, United Statesno status→Recruiting
  • Site 104 · The Bronx, United Statesno status→Recruiting
  • Site 109 · Mt. Pleasant, United Statesno status→Not yet recruiting
  • Site 107 · Tyler, United Statesno status→Recruiting
  • Site 106 · Mill Creek, United Statesno status→Not yet recruiting
Show 24 added (16 United States, 8 Canada)
  • Site 117 · Birmingham, United States
  • Site 119 · Rogers, United States
  • Site 113 · Coral Gables, United States
  • Site 115 · Atlanta, United States
  • Site 116 · Owensboro, United States
  • Site 112 · Boston, United States
  • Site 127 · Detroit, United States
  • Site 120 · Las Vegas, United States
  • Site 126 · Las Vegas, United States
  • Site 124 · Durham, United States
  • Site 122 · Oklahoma City, United States
  • Site 125 · Nashville, United States
  • Site 118 · Smyrna, United States
  • Site 114 · Prosper, United States
  • Site 121 · Tyler, United States
  • Site 123 · Murray, United States
  • Site 163 · Edmonton, Canada
  • Site 165 · Surrey, Canada
  • Site 164 · Winnipeg, Canada
  • Site 160 · Barrie, Canada
  • Site 167 · Markham, Canada
  • Site 162 · Richmond Hill, Canada
  • Site 166 · Québec, Canada
  • Site 161 · Saskatoon, Canada
Show 2 removed
  • Site 110 · New Orleans, United States
  • Site 105 · Dallas, United States
Oct 19, 2026
Show all 1 update
  1. Oct 19, 2026
    Not yet recruiting→Recruiting
    24 sites added, 2 sites removed — first site in Canada. 10 sites changed recruiting status (5 now not yet recruiting, 5 now recruiting)
    Show 10 sites
    • Site 111 · Irvine, United Statesno status→Not yet recruiting
    • Site 101 · Indianapolis, United Statesno status→Recruiting
    • Site 100 · Bowling Green, United Statesno status→Recruiting
    • Site 108 · Baton Rouge, United Statesno status→Not yet recruiting
    • Site 103 · Boston, United Statesno status→Not yet recruiting
    • Site 102 · New York, United Statesno status→Recruiting
    • Site 104 · The Bronx, United Statesno status→Recruiting
    • Site 109 · Mt. Pleasant, United Statesno status→Not yet recruiting
    • Site 107 · Tyler, United Statesno status→Recruiting
    • Site 106 · Mill Creek, United Statesno status→Not yet recruiting
    Show 24 added (16 United States, 8 Canada)
    • Site 117 · Birmingham, United States
    • Site 119 · Rogers, United States
    • Site 113 · Coral Gables, United States
    • Site 115 · Atlanta, United States
    • Site 116 · Owensboro, United States
    • Site 112 · Boston, United States
    • Site 127 · Detroit, United States
    • Site 120 · Las Vegas, United States
    • Site 126 · Las Vegas, United States
    • Site 124 · Durham, United States
    • Site 122 · Oklahoma City, United States
    • Site 125 · Nashville, United States
    • Site 118 · Smyrna, United States
    • Site 114 · Prosper, United States
    • Site 121 · Tyler, United States
    • Site 123 · Murray, United States
    • Site 163 · Edmonton, Canada
    • Site 165 · Surrey, Canada
    • Site 164 · Winnipeg, Canada
    • Site 160 · Barrie, Canada
    • Site 167 · Markham, Canada
    • Site 162 · Richmond Hill, Canada
    • Site 166 · Québec, Canada
    • Site 161 · Saskatoon, Canada
    Show 2 removed
    • Site 110 · New Orleans, United States
    • Site 105 · Dallas, United States
    + 1 other change: verification date

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07766005
Lead sponsor
Spyre Therapeutics, Inc.
Responsible party
Sponsor
First posted
Aug 14, 2026
Start date
Sep 2026 (estimated)
Primary completion
Oct 2027 (estimated)
Completion
Jun 2028 (estimated)
Last update
Oct 19, 2026

Study contacts

SKYLIGHT Trial Center
Contact
info@SKYLIGHT-trial.com
1-702-602-7976
Joshua Friedman, MD, PhD
study director · Spyre Therapeutics, Inc.

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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