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

Clinical Trial Details

This phase 3 program is evaluating the efficacy and safety of tulisokibart in participants with moderately to severely active Crohn’s Disease.

In this research study an investigational drug named tulisokibart (MK-7240) is being tested for the treatment of Crohn’s disease. Tulisokibart works by targeting tumor necrosis factor (TNF)-like cytokine 1A (TL1A), a protein that helps regulate inflammation and fibrosis (thickening or scarring of tissue). Tulisokibart is an investigational drug because its safety, effectiveness, and how it works is still being studied. Tulisokibart is not yet approved by the United States Food and Drug Administration (FDA).

The purpose of this research is to test the safety of the trial drug tulisokibart and see how well tulisokibart works compared to placebo when treating people with moderately to severely active Crohn’s disease. Another purpose of this study is to measure the effects that Tulisokibart has on the body in terms of how the body absorbs, distributes, and removes the study drug (called pharmacokinetics or PK).

This protocol consists of 2 independent studies: Study 1 (3 treatment periods [induction and maintenance and extension]) and Study 2 (2 treatment periods [induction only and extension]). Each study has its own hypotheses and outcome measures that will be assessed independently. Study 2 enrollment may be initiated when Study 1 has reached target enrollment of advanced therapy-experienced participants (65%) or is fully enrolled.

Tulisokibart is administered either through an intravenous (IV) infusion or subcutaneous (SC) injection. The dose depends on which arm of the study participants are enrolled in. All participants will be required to come into the clinic to receive the tulisokibart infusion or injection.

Key Eligibility:

Inclusion criteria

Participants must be 18 to 75 years old, inclusive.
Participants must have a confirmed diagnosis of Crohn’s Disease (CD) for at least 3 months prior to randomization, as confirmed by both endoscopy and histology.
Participants must have moderately to severely active CD
Participants must have had an inadequate response or loss of response to one or two of the following therapies:

a) Oral or IV steroids (e.g., inability to taper or relapse).
b) Immunomodulators (e.g., AZA, 6-MP, IM/SC MTX).
c) Advanced therapies (e.g., TNF inhibitors, JAK inhibitors, IL-23 inhibitors, IL-12/23 inhibitors, S1P modulators).
OR intolerance to one or two of the therapies above.

Exclusion Criteria:

Participants with other Conditions: Ulcerative colitis, indeterminate colitis, or any other form of colitis.
Active complications of CD, such as abscesses, symptomatic strictures, or any condition that may require surgery.
Participants who are not on stable doses of concomitant medications (e.g., antibiotics, aminosalicylates, steroids, or immunomodulators) prior to baseline.
Active infections (HBV, HCV, HIV, TB) will be assessed based on standard safety criteria.

For detailed eligibility, please contact the study team.

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Study contact by location

Upper East Side - Manhattan

Contact(s)

Fatiha Chabouni
(212) 746-5109
fac2005@med.cornell.edu

Primary Investigator(s)

Randy Longman, MD, PhD

Protocol ID(s)

Weill Cornell Medicine IRB #:

2404027346

ClinicalTrials.gov:

NCT06430801

Age Group

Adult

Disease

Crohn's Disease