Study to Evaluate Tulisokibart for Hidradenitis Suppurativa (MK-7240-012)

Running, not enrolling · Phase 2 · Has a placebo group

Conditions studied: Hidradenitis Suppurativa

In brief

This is a phase 2b randomized, double-blind, placebo-controlled study of the safety and efficacy of tulisokibart in participants with moderate to severe hidradenitis suppurativa. The primary hypothesis is that at least 1 dose of tulisokibart is superior to placebo with respect to the proportion of participants achieving a 50% reduction in Hidradenitis Suppurativa Clinical Response (HiSCR50) at Week 16 (ie, at end of double-blind treatment).

Key facts

Study ID

NCT06956235

Run by

Merck Sharp & Dohme LLC

People needed

147

Starts

2025-06-09

Expected to finish

2029-01-22

Last updated by the study team

2026-01-20

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Has signs and symptoms of hidradenitis suppurativa (HS) for ≥6 months prior to Screening and a clinical diagnosis of HS at Screening
• Has moderate or severe HS defined as a total combined number of ≥ 5 abscesses and/or inflammatory nodules, with HS lesions present in ≥ 2 distinct anatomical areas and ≥ 1 anatomic area of HS involvement characterized as Hurley Stage II or III
• Has a history of inadequate response to a course of systemic antibiotics for treatment of HS or intolerance to or has a contraindication to systemic antibiotics for treatment of HS
• Has ≤20 draining tunnel count at Screening and Randomization

You may not qualify if…

• Has other active skin conditions that may, in the judgment of the investigator, interfere with the assessment of HS
• Has any immune-mediated inflammatory condition that is not well controlled and which may potentially require biologic therapy
• Has a transplanted organ and requires continued systemic immunosuppression
• Has a history of cancer (except fully treated nonmelanoma skin cancers or cervical carcinoma in situ after complete surgical removal) and is disease free for <5 years
• Has had a diagnostic evaluation suggestive of malignancy (eg, chest or breast imaging) and the possibility of malignancy cannot be reasonably excluded following additional clinical assessments
• Has a known infection with hepatitis B virus (HBV), hepatitis C virus (HCV), or human immunodeficiency virus (HIV)
• Has any active infection
• Has active tuberculosis
• Has had major surgery within the past 3 months or has a major surgery planned during the study
• Has a history of clinically significant drug or alcohol abuse within the past 6 months
• Has prior exposure to tulisokibart
• Has undergone laser therapy or surgical procedures for their lesions within the past 6 weeks or is planning to have laser therapy or surgical procedures for lesions during participation in the study
• Has known allergies, hypersensitivity, or intolerance to tulisokibart or its excipients

Where it is running

• Medical Dermatology Specialists ( Site 0027) — Phoenix, Arizona, United States
• Northwest Arkansas Clinical Trials Center, PLLC ( Site 0049) — Rogers, Arkansas, United States
• Northridge Clinical Trials ( Site 0004) — Northridge, California, United States
• Integrative Skin Science and Research ( Site 0015) — Sacramento, California, United States
• Olympian Clinical Research ( Site 0010) — Tampa, Florida, United States
• Skin Care Physicians of Georgia ( Site 0033) — Macon, Georgia, United States
• Dawes Fretzin Clinical Research Group, LLC ( Site 0025) — Indianapolis, Indiana, United States
• Beth Israel Deaconess Medical Center ( Site 0044) — Boston, Massachusetts, United States
• Revival Research Institute, LLC ( Site 0005) — Troy, Michigan, United States
• Mount Sinai Doctors - East 85th Street ( Site 0050) — New York, New York, United States
• DJL Clinical Research, PLLC ( Site 0021) — Charlotte, North Carolina, United States
• University Hospitals Cleveland Medical Center ( Site 0046) — Cleveland, Ohio, United States
• Wright State Physicians Health Center ( Site 0041) — Fairborn, Ohio, United States
• Palmetto Clinical Trial Services, LLC ( Site 0023) — Anderson, South Carolina, United States
• Arlington Center for Dermatology ( Site 0045) — Arlington, Texas, United States
• Texas Dermatology Research Center ( Site 0019) — Dallas, Texas, United States
• Reveal Research Institute ( Site 0018) — Frisco, Texas, United States
• Progressive Clinical Research ( Site 0020) — San Antonio, Texas, United States
• CIPREC ( Site 0202) — CABA, Argentina
• Hospital Italiano de Buenos Aires ( Site 0205) — CABA, Argentina
• Psoriahue ( Site 0203) — CABA, Argentina
• Derma Internacional SA ( Site 0206) — CABA, Argentina
• Liverpool Hospital ( Site 1403) — Liverpool, New South Wales, Australia
• The Alfred Hospital ( Site 1401) — Melbourne, Victoria, Australia
• Cahaba Dermatology & Skin Health Center ( Site 0012) — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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