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

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
Merck Sharp & Dohme LLC
Study ID
NCT06956235
Phase
PHASE2
Status
Active Not Recruiting

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Tulisokibart — DRUG
    Solution in autoinjector for subcutaneous (SC) injection
  • Placebo — DRUG
    Solution in autoinjector for SC injection

Study Details

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 Dates

Start date
Jun 9, 2025
Status verified
Jan 2026
Primary completion
Nov 16, 2026
Completion
Jan 22, 2029

Study Design

Enrollment
147 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Arm 1: High Dose
    Participants receive a high dose tulisokibart regimen.
  • Experimental: Arm 2: Medium Dose
    Participants receive a medium dose tulisokibart regimen.
  • Experimental: Arm 3: Low Dose
    Participants receive a low dose tulisokibart regimen.
  • 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.

Primary Outcome Measure

Percentage of Participants Achieving Hidradenitis Suppurativa Clinical Response (HiSCR) 50 at Week 16 [ Time Frame: Week 16 ]

Locations (19)

FacilityCityStateZIPSite coordinators
Cahaba Dermatology & Skin Health Center ( Site 0012)BirminghamAlabama35244-
Medical Dermatology Specialists ( Site 0027)PhoenixArizona85006-
Northwest Arkansas Clinical Trials Center, PLLC ( Site 0049)RogersArkansas72758-
Northridge Clinical Trials ( Site 0004)NorthridgeCalifornia91325-
Integrative Skin Science and Research ( Site 0015)SacramentoCalifornia95815-
Olympian Clinical Research ( Site 0010)TampaFlorida33615-
Skin Care Physicians of Georgia ( Site 0033)MaconGeorgia31217-
Dawes Fretzin Clinical Research Group, LLC ( Site 0025)IndianapolisIndiana46250-
Beth Israel Deaconess Medical Center ( Site 0044)BostonMassachusetts02215-
Revival Research Institute, LLC ( Site 0005)TroyMichigan48084-
Mount Sinai Doctors - East 85th Street ( Site 0050)New YorkNew York10028-
DJL Clinical Research, PLLC ( Site 0021)CharlotteNorth Carolina28211-
University Hospitals Cleveland Medical Center ( Site 0046)ClevelandOhio44106-
Wright State Physicians Health Center ( Site 0041)FairbornOhio45324-
Palmetto Clinical Trial Services, LLC ( Site 0023)AndersonSouth Carolina29621-
Arlington Center for Dermatology ( Site 0045)ArlingtonTexas76011-
Texas Dermatology Research Center ( Site 0019)DallasTexas75246-
Reveal Research Institute ( Site 0018)FriscoTexas75033-
Progressive Clinical Research ( Site 0020)San AntonioTexas78213-

Find similar trials in Birmingham, AL

By condition
Hidradenitis suppurativa
By specialty
DermatologyRheumatologyAutoimmune disease
By research site
Cahaba Dermatology & Skin Health Center· Birmingham, ALMedical Dermatology Specialists· Phoenix, AZNorthwest Arkansas Clinical Trials Center, PLLC· Rogers, ARNorthridge Clinical Trials· Northridge, CAIntegrative Skin Science and Research· Sacramento, CAOlympian Clinical Research· Tampa, FL

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