Tulisokibart for Hidradenitis Suppurativa

Recruiting at 8 trial locations

Overseen By Toll Free Number

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Merck Sharp & Dohme LLC

Must not be taking: Biologics, Immunosuppressants

Disqualifiers: Active skin conditions, Cancer, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

147 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

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).

Who Is on the Research Team?

Medical Director

Principal Investigator

Merck Sharp & Dohme LLC

Are You a Good Fit for This Trial?

This trial is for individuals with moderate to severe hidradenitis suppurativa (HS), a skin condition, who haven't responded well to antibiotics or can't take them. Participants should have had HS symptoms for at least 6 months and no more than 20 draining tunnels at the time of screening.

Inclusion Criteria

Has moderate or severe HS

I've had a poor response or can't take antibiotics for my skin condition.

I have had symptoms of HS for 6 months or more and have been diagnosed with HS.

Exclusion Criteria

Has other active skin conditions that may interfere with the assessment of HS

Has known allergies, hypersensitivity, or intolerance to tulisokibart or its excipients

I have an immune condition that might need biologic therapy.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Double-blind Treatment

Participants receive either a high, medium, or low dose of tulisokibart or placebo for 16 weeks

16 weeks

Main Extension

Participants continue treatment in a 40-week main extension period

40 weeks

Optional Extension

Participants may opt into a 60-week optional extension for long-term treatment

60 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Tulisokibart

Trial Overview The study tests Tulisokibart against a placebo in people with HS. It's randomized and double-blind, meaning neither participants nor researchers know who gets the real drug. The goal is to see if Tulisokibart helps reduce HS symptoms by at least half after 16 weeks.

How Is the Trial Designed?

Group I: Arm 3: Low Dose Experimental Treatment 1 Intervention

Participants receive a low dose tulisokibart regimen.

Group II: Arm 2: Medium Dose Experimental Treatment 1 Intervention

Participants receive a medium dose tulisokibart regimen.

Group III: Arm 1: High Dose Experimental Treatment 1 Intervention

Participants receive a high dose tulisokibart regimen.

Group IV: Arm 4: Placebo Placebo Group 1 Intervention

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

Who Is Running the Clinical Trial?

Merck Sharp & Dohme LLC

Lead Sponsor

Trials

4,096

Recruited

5,232,000+

Chirfi Guindo

Merck Sharp & Dohme LLC

Chief Marketing Officer since 2022

Degree in Engineering from Ecole Centrale de Paris, MBA from New York University Stern School of Business

Robert M. Davis

Merck Sharp & Dohme LLC

Chief Executive Officer since 2021

JD from Northwestern University Pritzker School of Law, MBA from Northwestern University Kellogg Graduate School of Management, Bachelor's in Finance from Miami University