Olatorepatide vs placebo for adults with moderate-to-severe hidradenitis suppurativa who are overweight

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 phase 2 interventional trial compares olatorepatide to placebo in adults with moderate to severe hidradenitis suppurativa and a BMI of 27 or higher. Participants will have HS lesions in at least two distinct areas and a minimum inflammatory lesion count, and will apply antiseptics daily to HS-affected skin. The study will evaluate safety, efficacy, drug levels over time, and antibody development that could affect treatment. Enrollment is at a single site in the Bronx, New York, sponsored by Regeneron with Equity Medical, LLC as the participating site.

Why it matters

Who can join: the full rules

Key Inclusion Criteria:

1. Diagnosis of HS based on:

   1. Documented or reported history of HS for ≥6 months prior to baseline visit
   2. Confirmation of HS by the investigator during physical examination at screening
2. HS lesions present in at least 2 distinct anatomic areas as described in the protocol
3. Moderate to severe HS, defined as a total of ≥5 inflammatory lesions (ie, number of abscesses plus number of inflammatory nodules) at both screening (visit 1) and baseline (visit 2)
4. Agree to daily use of over-the-counter topical antiseptics (eg, chlorhexidine gluconate, benzoyl peroxide, or diluted bleach \[bath\], or alternative antiseptic agents in accordance with local/country guidelines) applied to HS-affected areas as described in the protocol
5. Body Mass Index (BMI) ≥27.0 kg/m2 at screening

Key Exclusion Criteria:

1. Has a sensitivity (or history of hypersensitivity reactions) to any of the trial interventions, or components thereof, or other allergy that, in the opinion of the investigator or medical monitor, contraindicates participation in the trial
2. Cardiovascular or cerebrovascular events or procedures within 90 days prior to screening, including myocardial infarction, hospitalization for unstable angina, coronary artery bypass graft, percutaneous coronary intervention as described in the protocol
3. Current heart failure classified as being in NYHA Class IV at screening
4. History of chronic pancreatitis or acute pancreatitis
5. Presence of serious Gastrointestinal (GI) disorders (eg, active peptic ulcer, inflammatory bowel disease) at screening
6. Have a previous or current diagnosis of Type 1 Diabetes (T1D) or any other type of diabetes except Type 2 Diabetes (T2D) as described in the protocol

Note: Other Protocol Defined Inclusion/ Exclusion Criteria Apply

Where it's running

• Equity Medical, LLC
  The Bronx, New York, United States Recruiting

Study contacts

• Study coordinator: Clinical Trials Administrator
• Email: clinicaltrials@regeneron.com
• Phone: 844-734-6643

Similar studies

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

• BTK inhibitor remibrutinib in hidradenitis suppurativa shows how it works in adults

  This phase 1 trial tests whether remibrutinib can safely affect HS in adults with moderate to severe disease.

  Recruiting at 2 sites Phase 1 Novartis · San Diego, California and 1 other locations · NCT07855276

• Remibrutinib extension study for adults with moderate to severe hidradenitis suppurativa

  This extension study tests whether continuing remibrutinib is safe and helps skin symptoms in adults who completed prior HS trials.

  Recruiting at 61 sites Phase 3 Novartis · Birmingham, Alabama and 60 other locations · NCT07665437

• LAD328 in adults with hidradenitis suppurativa

  This study tests whether LAD328 works better than placebo for adults with moderate-to-severe hidradenitis suppurativa.

  Recruiting Phase 2 Almirall, S.A. · Warsaw, Masovian Voivodeship · NCT07547813

• Long-term real-world tracking of secukinumab treatment for moderate to severe hidradenitis suppurativa in Italy

  This project will see how secukinumab works and is used in adults with moderate to severe hidradenitis suppurativa in Italy.

  Recruiting at 16 sites Novartis · Ancona, AN and 15 other locations · NCT07543419

• Secukinumab outcomes in Canadians with hidradenitis suppurativa

  It will see how well secukinumab works and how safe it is for adults in Canada with moderate-to-severe hidradenitis suppurativa who were newly prescribed it in routine care.

  Recruiting at 15 sites Novartis · Calgary, Alberta and 14 other locations · NCT07282015

• Post-marketing surveillance of Cosentyx (secukinumab) for hidradenitis suppurativa, pediatric plaque psoriasis, and juvenile idiopathic arthritis in Korea

  This study will see how Cosentyx (secukinumab) works and is tolerated in people in Korea with moderate-to-severe hidradenitis suppurativa, pediatric plaque psoriasis, or juvenile idiopathic arthritis who are being treated in routine care.

  Recruiting Novartis · Seoul, Seoul · NCT07243782

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.