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Small Molecule
Tulisokibart for Crohn's Disease
Phase 3
Recruiting
Research Sponsored by Merck Sharp & Dohme LLC
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
* 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)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to approximately 378 weeks
Awards & highlights
Pivotal Trial
Summary
This trial is about studying a medication called tulisokibart for treating Crohn's disease and ulcerative colitis. They want to see how safe and well-tolerated the medication is over
Who is the study for?
This trial is for people who have moderate to severe Crohn's disease or ulcerative colitis and were part of earlier tulisokibart studies. They must be seeing benefits from the treatment, not pregnant or breastfeeding, and if they can get pregnant, they need to use birth control or practice abstinence.
What is being tested?
The study is testing the long-term safety and effectiveness of a drug called tulisokibart in patients with Crohn's disease or ulcerative colitis. Participants are those who've taken it before in previous phases of research.
What are the potential side effects?
While specific side effects aren't listed here, participants will be monitored for any adverse reactions over time as they continue using tulisokibart to manage their condition.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I use birth control or practice long-term abstinence.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to approximately 378 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to approximately 378 weeks
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Number of Participants Who Discontinue Study Treatment Due to an AE
Number of Participants Who Experience an Adverse Event (AE)
Secondary study objectives
Percentage of Participants with Crohn's Disease Achieving Clinical Remission per Crohn's Disease Activity Index (CDAI) Score
Percentage of Participants with Crohn's Disease Achieving Clinical Remission per Stool Frequency and Abdominal Pain Score
Percentage of Participants with Crohn's Disease With Endoscopic Remission Per Simplified Endoscopic Score for Crohn's Disease (SES-CD)
+1 moreAwards & Highlights
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Trial Design
4Treatment groups
Experimental Treatment
Group I: Group 4: Low Dose BlindedExperimental Treatment2 Interventions
Participants receive a blinded low dose SC tulisokibart regimen.
Group II: Group 3: High Dose BlindedExperimental Treatment1 Intervention
Participants receive a blinded high dose SC tulisokibart regimen.
Group III: Group 2: High Dose UnblindedExperimental Treatment1 Intervention
Participants receive a high dose SC tulisokibart regimen.
Group IV: Group 1: Low Dose UnblindedExperimental Treatment1 Intervention
Participants receive a low dose subcutaneous (SC) tulisokibart regimen.
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Who is running the clinical trial?
Merck Sharp & Dohme LLCLead Sponsor
4,032 Previous Clinical Trials
5,188,452 Total Patients Enrolled
15 Trials studying Ulcerative Colitis
4,700 Patients Enrolled for Ulcerative Colitis
Medical DirectorStudy DirectorMerck Sharp & Dohme LLC
2,905 Previous Clinical Trials
8,090,120 Total Patients Enrolled
8 Trials studying Ulcerative Colitis
4,008 Patients Enrolled for Ulcerative Colitis