A Study to Evaluate the Efficacy and Safety of Tulisokibart (MK-7240) in Participants With Moderate to Severe Crohn's Disease (MK-7240-008)

Summary

The purpose of this protocol is to evaluate the efficacy and safety of tulisokibart in participants with moderately to severely active Crohn's disease. Study 1's primary hypotheses are that at least 1 tulisokibart dose level is superior to placebo in the proportion of participants achieving clinical remission per Crohn's Disease Activity Index score (\<150, US/FDA) or per stool frequency and abdominal pain score (EU/EMA) and in the proportion of participants achieving endoscopic response at Week 52 (US/FDA and EU/EMA), and that at least 1 tulisokibart dose level is superior to placebo in the proportion of participants achieving clinical remission per Crohn's Disease Activity Index score (\<150, US/FDA) or per stool frequency and abdominal pain score (EU/EMA) and in the proportion of participants achieving endoscopic response at Week 12 (US/FDA and EU/EMA). Study 2's primary hypothesis is that at least 1 tulisokibart dose level is superior to placebo in the proportion of participants achieving clinical remission per Crohn's Disease Activity Index score (\<150, US/FDA) or stool frequency and abdominal pain score (EU/EMA) and in the proportion of participants achieving endoscopic response at Week 12 (US/FDA and EU/EMA).

Conditions

• Crohn's Disease

Interventions

DRUG

IV Tulisokibart

Humanized monoclonal antibody that binds human tumor necrosis factor-like cytokine 1A (TL1A), administered intravenously

DRUG

SC Tulisokibart

Humanized monoclonal antibody that binds human TL1A, administered subcutaneously

OTHER

IV Placebo

Placebo matching IV tulisokibart

OTHER

SC Placebo

Placebo matching SC tulisokibart

Sponsors & Collaborators

• Merck Sharp & Dohme LLC

  lead INDUSTRY

Principal Investigators

• Medical Director · Merck Sharp & Dohme LLC

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

16 Years

Max Age

80 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-06-05

Primary Completion

2028-10-30

Completion

2029-11-12

FDA Drug

Yes

Countries

• United States
• Australia
• Austria
• Belgium
• Brazil
• Canada
• Chile
• China
• Colombia
• Croatia
• Czechia
• Denmark
• Dominican Republic
• Finland
• France
• Georgia
• Germany
• Greece
• Hong Kong
• Hungary
• Ireland
• Israel
• Italy
• Japan
• Latvia
• Lithuania
• Malaysia
• Mexico
• Netherlands
• New Zealand
• Peru
• Poland
• Portugal
• Romania
• Saudi Arabia
• Serbia
• Singapore
• Slovakia
• South Africa
• South Korea
• Spain
• Sweden
• Switzerland
• Taiwan
• Turkey (Türkiye)
• Ukraine
• United Kingdom

Study Locations