ACTIVE_NOT_RECRUITING

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

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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).

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

Quick Facts

Study Start:2025-06-09

Study Completion:2029-01-22

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:ACTIVE_NOT_RECRUITING

Study ID

NCT06956235

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 75 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* 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	* 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

Inclusion Criteria

Exclusion Criteria

* 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

* 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

Contacts and Locations

Principal Investigator

Medical Director

STUDY_DIRECTOR

Merck Sharp & Dohme LLC

Study Locations (Sites)

Cahaba Dermatology & Skin Health Center ( Site 0012)

Birmingham, Alabama, 35244

United States

Medical Dermatology Specialists ( Site 0027)

Phoenix, Arizona, 85006

United States

Northwest Arkansas Clinical Trials Center, PLLC ( Site 0049)

Rogers, Arkansas, 72758

United States

Northridge Clinical Trials ( Site 0004)

Northridge, California, 91325

United States

Integrative Skin Science and Research ( Site 0015)

Sacramento, California, 95815

United States

Olympian Clinical Research ( Site 0010)

Tampa, Florida, 33615

United States

Skin Care Physicians of Georgia ( Site 0033)

Macon, Georgia, 31217

United States

Dawes Fretzin Clinical Research Group, LLC ( Site 0025)

Indianapolis, Indiana, 46250

United States

Beth Israel Deaconess Medical Center ( Site 0044)

Boston, Massachusetts, 02215

United States

Revival Research Institute, LLC ( Site 0005)

Troy, Michigan, 48084

United States

Mount Sinai Doctors - East 85th Street ( Site 0050)

New York, New York, 10028

United States

DJL Clinical Research, PLLC ( Site 0021)

Charlotte, North Carolina, 28211

United States

University Hospitals Cleveland Medical Center ( Site 0046)

Cleveland, Ohio, 44106

United States

Wright State Physicians Health Center ( Site 0041)

Fairborn, Ohio, 45324

United States

Palmetto Clinical Trial Services, LLC ( Site 0023)

Anderson, South Carolina, 29621

United States

Arlington Center for Dermatology ( Site 0045)

Arlington, Texas, 76011

United States

Texas Dermatology Research Center ( Site 0019)

Dallas, Texas, 75246

United States

Reveal Research Institute ( Site 0018)

Frisco, Texas, 75033

United States

Progressive Clinical Research ( Site 0020)

San Antonio, Texas, 78213

United States

Collaborators and Investigators

Sponsor: Merck Sharp & Dohme LLC

Medical Director, STUDY_DIRECTOR, Merck Sharp & Dohme LLC

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-06-09

Study Completion Date2029-01-22

Study Record Updates

Study Start Date2025-06-09

Study Completion Date2029-01-22

Terms related to this study

Additional Relevant MeSH Terms

Hidradenitis Suppurativa