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

Purpose

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).

Condition

  • Hidradenitis Suppurativa

Eligibility

Eligible Ages
Between 18 Years and 75 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Has signs and symptoms of hidradenitis suppurativa (HS) for ≥ 6 months and a clinical diagnosis of HS at screening - Has moderate or severe HS - 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

Exclusion Criteria

  • Has other active skin conditions that may 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 non-melanoma skin cancers or cervical carcinoma in situ after complete surgical removal) within the last 5 years - Has known allergies, hypersensitivity, or intolerance to tulisokibart or its excipients

Study Design

Phase
Phase 2
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Triple (Participant, Investigator, Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Arm 1: High Dose 		Participants receive a high dose tulisokibart regimen.
  • Drug: Tulisokibart
    Solution in autoinjector for subcutaneous (SC) injection
    Other names:
    • PRA023
    • MK-7240
Experimental
Arm 2: Medium Dose 		Participants receive a medium dose tulisokibart regimen.
  • Drug: Tulisokibart
    Solution in autoinjector for subcutaneous (SC) injection
    Other names:
    • PRA023
    • MK-7240
Experimental
Arm 3: Low Dose 		Participants receive a low dose tulisokibart regimen.
  • Drug: Tulisokibart
    Solution in autoinjector for subcutaneous (SC) injection
    Other names:
    • PRA023
    • MK-7240
Placebo Comparator
Arm 4: Placebo 		Participants receive a placebo regimen, and are then allocated to a medium or high tulisokibart dose regimen after Week 16.
  • Drug: Placebo
    Solution in autoinjector for SC injection

Recruiting Locations

Cahaba Dermatology & Skin Health Center ( Site 0012)
Birmingham, Alabama 35244
Contact:
Study Coordinator
205-850-5528

Northridge Clinical Trials ( Site 0004)
Northridge, California 91325
Contact:
Study Coordinator
818-350-7483

Integrative Skin Science and Research ( Site 0015)
Sacramento, California 95815
Contact:
Study Coordinator
916-524-1216

Skin Care Physicians of Georgia ( Site 0033)
Macon, Georgia 31217
Contact:
Study Coordinator
478-742-2180

Dawes Fretzin Clinical Research Group, LLC ( Site 0025)
Indianapolis, Indiana 46250
Contact:
Study Coordinator
317-516-5030

Revival Research Institute, LLC ( Site 0005)
Troy, Michigan 48084
Contact:
Study Coordinator
248-590-0298

DJL Clinical Research, PLLC ( Site 0021)
Charlotte, North Carolina 28211
Contact:
Study Coordinator
704-247-9179

Wright State Physicians Health Center ( Site 0041)
Fairborn, Ohio 45324
Contact:
Study Coordinator
937-245-7500

Palmetto Clinical Trial Services, LLC ( Site 0023)
Anderson, South Carolina 29621
Contact:
Study Coordinator
864-622-8480

Arlington Center for Dermatology ( Site 0045)
Arlington, Texas 76011
Contact:
Study Coordinator
817-795-7546

Texas Dermatology Research Center ( Site 0019)
Dallas, Texas 75246
Contact:
Study Coordinator
469-251-1828

Reveal Research Institute ( Site 0018)
Frisco, Texas 75033
Contact:
Study Coordinator
469-225-9920

Progressive Clinical Research ( Site 0020)
San Antonio, Texas 78213
Contact:
Study Coordinator
210-614-5557

More Details

NCT ID
NCT06956235
Status
Recruiting
Sponsor
Merck Sharp & Dohme LLC

Study Contact

Toll Toll Free Number
1-888-577-8839
Trialsites@msd.com

Detailed Description

This study consists of a 16-week Double-blind Period and a 100-week Long-term Extension (LTE) composed of a 40-week Main Extension and a 60-week Optional Extension.

For help using this page: trialstoday@researchmatch.org or call 855-514-7001

ResearchMatch is funded in part by the National Institutes of Health (NIH) Clinical and Translational Science Award (CTSA) program, led by the NIH’s National Center for Advancing Translational Sciences (NCATS), grants UL1TR000445 and 1U54RR032646-01, and grant U24TR001579 from NCATS and the National Library of Medicine. The content of this website is solely the responsibility of ResearchMatch and Vanderbilt University and does not necessarily represent the official views of the NIH, NCATS, or NLM.

Vanderbilt University Medical Center