Tulisokibart in Moderately to Severely Active Crohn's Disease

What is the Purpose of this Study?

The purpose of this study is to evaluate the safety and effectiveness of an experimental drug called tulisokibart (MK-7240) in people with moderately to severely active Crohn’s disease that has not responded well to treatment. Tulisokibart is an experimental drug with the potential to improve inflammation and fibrosis (thickening or scarring) of the bowel. Researchers will compare tulisokibart to placebo (inactive substance). Study procedures also include physical exams, laboratory tests, colonoscopies, and completion of questionnaires. There are 2 studies in this trial. Study 1 has 4 groups; participants will be randomly assigned to one of these 4 groups. In Study 1, Groups 1, 2, and 3 will receive different doses of tulisokibart, and Group 4 will receive placebo only. Study 2 has 3 groups; participants will be randomly assigned to one of these 3 groups. Group 1 and Group 2 will receive different doses of tulisokibart, and Group 3 will receive placebo only.


Eligibility

  • * Has had a diagnosis of CD at least 3 months before study.
  • * Has moderately to severely active CD.
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Where can I participate?

Beverly

More about this Clinical Trial

What is the full name of this clinical trial?

A Phase 3, Randomized, Double-Blind, Placebo-Controlled Program to Evaluate the Efficacy and Safety of Tulisokibart in Participants with Moderately to Severely Active Crohn?s Disease

Study Details
Disease Type/Condition

Other

Principal Investigator

Melmed, Gil

Age Group

Adult

Phase

III

IRB Number

STUDY00003483

ClinicalTrials.gov ID

NCT06430801

Key Eligibility
ClinicalTrials.gov

How do I learn more about this study?
Email
clinicaltrials@cshs.org
Study Detail
Disease Type/Condition

Other

Principal Investigator

Melmed, Gil

Age Group

Adult

Phase

III

IRB Number

MK-7240-008-00

ClinicalTrials.gov ID

NCT06430801

Key Eligibility
ClinicalTrials.gov

Contact
Email
clinicaltrials@cshs.org