ClinicaliQ Trial Snapshot
- Extension Study of Long-term Safety and Efficacy of Tulisokibart in Participants With Crohn’s Disease or Ulcerative Colitis (MK-7240-011) — Recruiting • Phase III • Rheumatology • NCT06651281.
- What is being tested: Long-term safety and efficacy of tulisokibart (MK-7240), a novel therapeutic agent designed to treat active, moderate to severe Crohn's disease and ulcerative colitis, through continued observation in an extension study phase.
- Patient eligibility overview: Participants who have completed a preceding tulisokibart trial and have confirmed diagnoses of either Crohn's disease or ulcerative colitis are eligible; this extension captures patients with established disease activity requiring moderate to severe treatment intervention.
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What This Trial Is Studying
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. The goals of this study are to learn about the safety of tulisokibart over time in people with CD or UC, and if people tolerate…
Eligibility Snapshot
- : * 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 the first dose of study intervention * 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)
Use the source registry for the full inclusion and exclusion criteria before discussing referral or enrolment.