Tulisokibart for Moderate to Severe Crohn's Disease
A Study to Evaluate the Efficacy and Safety of Tulisokibart (MK-7240) in Participants With Moderate to Severe Crohn's Disease (MK-7240-008)
Recruiting
Phase 3
Interventional Study
Crohn's Disease
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 16 – 80
- Sex
- Any
- Trial phase
- Phase 3
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 1,200 (estimated)
- Sponsor
- Merck Sharp & Dohme LLC · Industry
Who this trial is looking for
This trial is looking for people with moderate to severe Crohn's disease. Participants will take a medication called tulisokibart to see if it helps improve their condition compared to a placebo.
Are You a Good Fit for This Trial?
You may be able to join if
- I have been diagnosed with Crohn's disease for at least 3 months.
- I have moderately to severely active Crohn's disease.
- I have not responded well or cannot tolerate certain Crohn's medications.
- I am between 16 and 18 years old with approval from the health authority.
You may not be able to join if
- I have ulcerative colitis or indeterminate colitis.
- I have Crohn's disease only in specific areas of my digestive system.
- I currently have serious complications from Crohn's disease that might need surgery.
- I have a stoma or need a colostomy or ileostomy.
- I have had bowel surgery in the last 3 months.
- I have been diagnosed with certain infections or cancers.
- I am infected with Hepatitis B, Hepatitis C, or HIV.
- I have or suspect I have COVID-19.
Summarized in plain language from this trial's official eligibility criteria. The full criteria are further down this page — only the research team can confirm whether you qualify.
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Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
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About This Trial
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 abdom…
Trial Locations
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Eligibility Criteria
The main inclusion and exclusion criteria include but are not limited to the following:
Inclusion Criteria:
* 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 …
Contacts