Cure8 trial brief
This trial describes a large Phase 3 extension study collecting long-term safety and tolerability data for tulisokibart (MK-7240), an investigational TL1A-targeting antibody for Crohn’s disease and ulcerative colitis. Patients who completed qualifying parent trials may be eligible to continue receiving study drug.
Patients with Crohn’s disease or ulcerative colitis who completed a qualifying MK-7240 parent study, their caregivers, clinicians involved in IBD trials, and researchers interested in TL1A-targeted therapies.
This ClinicalTrials.gov record describes an open-label extension (with some blinded arms) Phase 3 extension study (MK-7240-011) run by Merck for tulisokibart (MK-7240), an investigational monoclonal antibody that targets TL1A for people who completed qualifying parent Phase 2 or Phase 3 studies in Crohn’s disease or ulcerative colitis.
The study’s main goals are to collect long-term safety and tolerability data and to follow adverse events and treatment discontinuations for up to about 7 years. Participants who derived clinical benefit in a qualifying parent study may enroll; study arms include low- and high-dose regimens, some blinded and some unblinded, and a matching placebo arm.
Primary outcomes listed are counts of participants experiencing adverse events and discontinuations due to adverse events over the long-term follow-up.
If you are taking part in a parent tulisokibart trial or considering continuing investigational therapy, this extension study is designed to offer continued access while gathering safety data, not to prove new efficacy outcomes.
This is a ClinicalTrials.gov trial record describing study design and planned safety outcomes; it does not contain study results. Enrollment is restricted to participants from qualifying parent studies and the primary outcomes focus on adverse events and discontinuations over long-term follow-up (up to ~378 weeks).
Review the original publication for the complete reporting, methods, and context.
This Cure8 brief is based on source text from the linked article. Cure8 is informational only and is not a substitute for professional medical advice, diagnosis, or treatment.
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