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
- NCT06956235
- EU 2024-520039-33-00
- JRCT2011250007
- U1111-1316-5263
- 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