Extension Study of Long-term Safety and Efficacy of Tulisokibart in Participants With Crohn's Disease or Ulcerative Colitis (MK-7240-011)

In plain English

What this trial is testing

This study is testing Tulisokibart (a drug) as a possible treatment. Condition(s) listed: Crohn Disease and Colitis, Ulcerative.

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

• Age range not stated in the record
• Any sex

Some of the main requirements, copied from the record:

• Has participated in a qualifying tulisokibart Phase 2 or Phase 3 parent study for CD or UC
• The investigator determines that the participant derives clinical benefit from continued study intervention based upon clinical evaluations performed during their parent study
• A participant assigned female sex at birth is not breastfeeding during the study intervention period and for at least 14 weeks after the last dose of study intervention
• A participant of childbearing potential (POCBP) is not pregnant and has a negative highly sensitive pregnancy test (urine or serum) as required by local regulations within 24 hours (for a urine test) or 72 hours (for a serum test) before…
• A POCBP uses an acceptable contraceptive method, or adheres to penile-vaginal intercourse abstinence as their preferred and usual lifestyle (abstinent on a long-term and persistent basis)

There are also 3 reasons someone might not be able to join (exclusion criteria). Only the trial team can confirm whether you qualify.

What's involved

• About 1380 participants are expected to take part.
• The study has 4 groups.
• Start date: 2024-11-25.
• Main results expected around 2037-12-17 (estimate from the record).
• 37 study sites listed (34 marked recruiting) in Czechia, France, Georgia, Hungary and Poland and 2 more countries.

Groups in this study

• Group 1: Low Dose Unblinded (listed as: experimental group)
• Group 2: High Dose Unblinded (listed as: experimental group)
• Group 3: High Dose Blinded (listed as: experimental group)
• Group 4: Low Dose Blinded (listed as: experimental group)

Main thing being measured

• Number of Participants Who Experience an Adverse Event (AE) (Up to approximately 378 weeks)
• Number of Participants Who Discontinue Study Treatment Due to an AE (Up to approximately 364 weeks)

In the researchers’ words

Researchers want to learn more about tulisokibart (also known as MK-7240) in an extension study. Tulisokibart is a medicine designed to treat active, moderate to severe Crohn's disease (CD) and ulcerative colitis (UC). An extension study is a type of study where people who received tulisokibart in certain other studies for CD or UC (called a parent study) may be able to join this study.

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.