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

In plain English

What this trial is testing

This study is testing IV Tulisokibart (a drug) and SC Tulisokibart (a drug) as a possible treatment. Condition(s) listed: Crohn's Disease.

Participants are assigned to groups by chance (randomized).

Some participants receive a placebo or sham for comparison.

It is blinded: participants and the study team do not know who receives what.

Phase 3 studies are large studies comparing a treatment with placebo or standard care. They are often the last step before a company asks regulators for approval.

Who can join

• Ages 16 to 80
• Any sex

Some of the main requirements, copied from the record:

• The main inclusion and exclusion criteria include but are not limited to the following:
• Has had a diagnosis of Crohn's disease (CD) at least 3 months before study.
• Has moderately to severely active CD.
• Demonstrated inadequate response, loss of response, or intolerance to one or more of the following categories of drugs: oral locally acting steroids, systemic steroids, immunomodulators, biologic and/or small molecule advanced therapies.
• Adolescent participants ≥16 and <18 years of age can participate if approved by the country or regulatory/health authority.

There are also 14 reasons someone might not be able to join (exclusion criteria). Only the trial team can confirm whether you qualify.

What's involved

• About 1200 participants are expected to take part.
• The study has 11 groups.
• Start date: 2024-06-05.
• Main results expected around 2028-10-30 (estimate from the record).
• 499 study sites listed (446 marked recruiting) in Australia, Austria, Belgium, Brazil and Canada and 42 more countries.

Groups in this study

• Study 1: High Dose Induction, High Dose Maintenance (listed as: experimental group)
• Study 1: High Dose Induction, Low Dose Maintenance (listed as: experimental group)
• Study 1: Low Dose Induction, Low Dose Maintenance (listed as: experimental group)
• Study 1: Placebo (listed as: placebo group)
• Study 1: High Dose Extension (listed as: experimental group)
• Study 1: Low Dose Extension (listed as: experimental group)

Main thing being measured

• Study 1 [US/FDA Only]: Percentage of Participants Achieving Clinical Remission per Crohn's Disease Activity Index (CDAI) Score at Week 52 (Week 52)
• Study 1 [EU/EMA Only]: Percentage of Participants Achieving Clinical Remission per Stool Frequency and Abdominal Pain Score at Week 52 (Week 52)
• Study 1: Percentage of Participants Achieving Endoscopic Response at Week 52 (Week 52)

In the researchers’ words

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…

This summary was written automatically from the official record using fixed templates (no AI), so it only says what the record says, and may leave things out.