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Active, not recruitingPhase 2

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

Key facts

Who runs it
Merck Sharp & Dohme LLC
Where
Anderson, Arlington, Birmingham, Boston, Charlotte, Cleveland, Dallas, Fairborn, Frisco, Indianapolis, Macon, New York, Northridge, Phoenix, Rogers, Sacramento, San Antonio, Tampa, and Troy, United StatesSee the 19 sitesAlso in 14 other countries, 45 sites
Trial code
Status
Active, not recruiting
Phase
Phase 2
People taking part
149 people enrolled
Started
9 Jun 2025
Expected to end
6 Jun 2028
Type of study
Interventional, 4 groupsOne group gets a placebo (a dummy treatment), for comparison.
Treatments tested
  • Tulisokibart
  • Placebo
Record updated
2 October 2026

Who can take part

Age
18 years to 75 years
Sex
Women and men
Healthy volunteers
Cannot take part

The registry criteria, word for word

Show all 17 criteriaShow less

Who can take part

  • 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

Who cannot take part

  • Has had major surgery within the past 3 months or has a major surgery planned during the study
  • 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 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 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 a history of clinically significant drug or alcohol abuse within the past 6 months
  • Has known allergies, hypersensitivity, or intolerance to tulisokibart or its excipients
  • 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 a transplanted organ and requires continued systemic immunosuppression

Where in United States

Also in 14 other countries, 45 sites

  • Palmetto Clinical Trial Services, LLC (Site 0023)Anderson, United StatesNo longer taking part
  • Arlington Center for Dermatology (Site 0045)Arlington, United StatesNo longer taking part
  • Cahaba Dermatology & Skin Health Center (Site 0012)Birmingham, United StatesNo longer taking part
  • Beth Israel Deaconess Medical Center (Site 0044)Boston, United StatesNo longer taking part
  • DJL Clinical Research, PLLC (Site 0021)Charlotte, United StatesNo longer taking part
  • University Hospitals Cleveland Medical Center (Site 0046)Cleveland, United StatesNo longer taking part
  • Texas Dermatology Research Center (Site 0019)Dallas, United StatesNo longer taking part
  • Wright State Physicians Health Center (Site 0041)Fairborn, United StatesNo longer taking part
  • Reveal Research Institute (Site 0018)Frisco, United StatesNo longer taking part
  • Dawes Fretzin Clinical Research Group, LLC (Site 0025)Indianapolis, United StatesNo longer taking part
  • Skin Care Physicians of Georgia (Site 0033)Macon, United StatesNo longer taking part
  • Mount Sinai Doctors - East 85th Street (Site 0050)New York, United StatesNo longer taking part
  • Northridge Clinical Trials (Site 0004)Northridge, United StatesNo longer taking part
  • Medical Dermatology Specialists (Site 0027)Phoenix, United StatesNo longer taking part
  • Northwest Arkansas Clinical Trials Center, PLLC (Site 0049)Rogers, United StatesNo longer taking part
  • Integrative Skin Science and Research (Site 0015)Sacramento, United StatesNo longer taking part
  • Progressive Clinical Research (Site 0020)San Antonio, United StatesNo longer taking part
  • Olympian Clinical Research (Site 0010)Tampa, United StatesNo longer taking part
  • Revival Research Institute, LLC (Site 0005)Troy, United StatesNo longer taking part

About the trial

What the trial wants to find out

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).

The 4 groups in the trial

  • Arm 1: High DoseTreatment being tested

    Participants receive a high dose tulisokibart regimen.

    Treatment: Tulisokibart

  • Arm 2: Medium DoseTreatment being tested

    Participants receive a medium dose tulisokibart regimen.

    Treatment: Tulisokibart

  • Arm 3: Low DoseTreatment being tested

    Participants receive a low dose tulisokibart regimen.

    Treatment: Tulisokibart

  • Arm 4: PlaceboPlacebo, for comparison

    Participants receive a placebo regimen, and are then allocated to a medium or high tulisokibart dose regimen after Week 16.

    Treatment: Placebo

Data and sources

Registry record
Listed on ClinicalTrials.gov and on the EU's official list of trials (CTIS).
Official title
A Phase 2b, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Tulisokibart in Participants With Moderate to Severe Hidradenitis Suppurativa
Record updated
2 October 2026