SPY072 in adults with moderate to severe hidradenitis suppurativa

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a Phase 2, multicenter, randomized, double-blind, placebo-controlled study evaluating SPY072 in adults aged 18 to 75 with moderate to severe hidradenitis suppurativa who are on advanced standard-of-care treatments. Approximately 150 eligible participants will be randomized to receive SPY072 or a matching placebo through Week 16, followed by a safety and durability assessment during a post-treatment follow-up. The trial includes parallel groups and a proof-of-concept design to explore whether SPY072 can improve HS activity beyond current therapies. Secondary analyses will consider safety and the duration of any treatment effects after stopping therapy.

Why it matters

Who can join: the full rules

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.

Where it's running

• Site 101
  Indianapolis, Indiana, United States Recruiting
• Site 100
  Bowling Green, Kentucky, United States Recruiting
• Site 116
  Owensboro, Kentucky, United States Recruiting
• Site 102
  New York, New York, United States Recruiting
• Site 104
  The Bronx, New York, United States Recruiting
• Site 125
  Nashville, Tennessee, United States Recruiting

Study contacts

• Study coordinator: SKYLIGHT Trial Center
• Email: info@SKYLIGHT-trial.com
• Phone: 1-702-602-7976

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Soquelitinib in adults with hidradenitis suppurativa

  This study tests whether oral soquelitinib can help adults with moderate-to-severe hidradenitis suppurativa.

  Recruiting at 9 sites Phase 1 Corvus Pharmaceuticals, Inc. · West Lafayette, Indiana and 10 other locations · NCT07828860

• ORKA-002 versus placebo for moderate-to-severe hidradenitis suppurativa

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  Recruiting at 25 sites Phase 2 Oruka Therapeutics, Inc. · Birmingham, Alabama and 24 other locations · NCT07783542

• Brain activity patterns in people with hidradenitis suppurativa and how treatments may relate to changes

  This study tests whether adults with hidradenitis suppurativa show different resting brain activity than healthy people and whether these brain patterns relate to symptoms like pain and mood, and whether they change after 3 months of standard biologic or small-molecule treatment.

  Recruiting Second Xiangya Hospital of Central South University · Changsha, Hunan · NCT07755670

• Roflumilast 0.3% Foam for Hidradenitis Suppurativa in Teens and Adults

  This study tests a topical roflumilast foam to see if it improves HS in adolescents and adults over 16 weeks.

  Recruiting Phase 2 Harrison Dermatology · Missouri City, Texas · NCT07689188

• Global health study on hidradenitis suppurativa

  This study tests how people with hidradenitis suppurativa access care and what treatments they receive across different health systems.

  Recruiting University of Zurich · Zurich · NCT07659769

• Secukinumab in Chinese adults with moderate to severe hidradenitis suppurativa

  This trial tests two dosing regimens of secukinumab to see if they can help Chinese adults with moderate to severe hidradenitis suppurativa.

  Recruiting at 10 sites Phase 4 Novartis · Guangzhou, Guangdong and 9 other locations · NCT07489573

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.