Extension Study of Long-term Safety and Efficacy of Tulisokibart in Participants With Crohn's Disease or Ulcerative Colitis (MK-7240-011)

Launched by MERCK SHARP & DOHME LLC · Oct 18, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a medication called tulisokibart, which is used to treat moderate to severe Crohn's disease and ulcerative colitis. This is an extension study, meaning it involves individuals who have previously participated in earlier studies of tulisokibart. The main goals are to find out how safe tulisokibart is over a longer period and how well patients tolerate it.

To be eligible for this study, participants must have taken part in a related study and shown a benefit from tulisokibart. They also need to meet certain health criteria, such as not being pregnant or breastfeeding during the study. If you join, you can expect regular check-ins with the research team to monitor your health and any side effects. This trial is actively recruiting participants, and everyone is welcome, regardless of gender. If you have Crohn's disease or ulcerative colitis and have previously participated in a related study, this might be an opportunity for you to continue receiving tulisokibart while helping researchers learn more about its long-term effects.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 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)
• Exclusion Criteria:
• • Has prematurely discontinued study intervention in their parent study
• • Has received any protocol-specified prohibited medications during their parent study
• • Has known allergies, hypersensitivity, or intolerance to tulisokibart or its excipients