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Monoclonal Antibodies

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

Has moderately to severely active CD

Must not have

Has diagnosis of ulcerative colitis (UC) or indeterminate colitis

Has CD isolated to the stomach, duodenum, jejunum, or perianal region, without colonic and/or ileal involvement

Timeline

Screening 3 weeks

Treatment Varies

Follow Up week 12 and week 52

Awards & highlights

Pivotal Trial

Summary

This trial aims to test the effectiveness and safety of a drug called tulisokibart in patients with Crohn's disease. The study will assess whether different doses of tulisokibart are

Who is the study for?

This trial is for people with moderate to severe Crohn's Disease. Participants should have active symptoms and be willing to receive either an IV or SC injection of the study drug or placebo. Specific details on who can join are not provided, but typically participants must meet certain health criteria.

What is being tested?

The trial is testing Tulisokibart, given through IV or SC injections, against a placebo to see if it helps achieve clinical remission and endoscopic response in Crohn's Disease patients at weeks 12 and 52.

What are the potential side effects?

While specific side effects of Tulisokibart aren't listed here, common side effects for treatments like this may include reactions at the injection site, gastrointestinal issues, headaches, fatigue, and potential immune system impacts.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My Crohn's disease is moderate to severe.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have been diagnosed with ulcerative colitis or indeterminate colitis.

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My Crohn's disease affects only my stomach and upper small intestine, not my colon or ileum.

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I have or need an opening made in my body for waste removal.

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I have been diagnosed with short gut syndrome or have chronic diarrhea not caused by Crohn's disease.

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I haven't had any cancer except for non-melanoma skin cancer or fully treated cervical cancer in the last 5 years.

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I have or might have COVID-19.

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I have previously been treated with tulisokibart or a similar medication.

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I have complications from Crohn's disease that may need surgery.

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I am missing more than two parts of my colon or rectum.

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I am on long-term medication for a chronic infection.

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I am infected with HBV, HCV, or HIV.

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I have active tuberculosis.

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I have had or currently have abnormal cell growth in my digestive tract.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ week 12 and week 52

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~week 12 and week 52

This trial's timeline: 3 weeks for screening, Varies for treatment, and week 12 and week 52 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Study 1 [EU/EMA Only]: Percentage of Participants Achieving Clinical Remission per Stool Frequency and Abdominal Pain Score at Week 52

Study 1 [US/FDA Only]: Percentage of Participants Achieving Clinical Remission per Crohn's Disease Activity Index (CDAI) Score at Week 52

Study 1: Percentage of Participants Achieving Clinical Remission per CDAI Score at Week 12

+10 more

Secondary study objectives

Study 1 [EU/EMA Only]: Percentage of Participants Achieving Clinical Remission per CDAI Score at Week 12

Study 1 [US/FDA Only]: Percentage of Participants Achieving Clinical Remission per Stool Frequency and Abdominal Pain Score at Week 12

Study 1 [US/FDA Only]: Percentage of Participants Achieving Clinical Remission per Stool Frequency and Abdominal Pain Score at Week 52

+24 more

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

11Treatment groups

Experimental Treatment

Placebo Group

Group I: Study 2: Low Dose InductionExperimental Treatment3 Interventions

Participants receive low dose IV tulisokibart.

Group II: Study 2: Low Dose ExtensionExperimental Treatment1 Intervention

Participants receive a low dose SC tulisokibart regimen. Participants may be enrolled in this arm only after completing participation in their original arm, if they meet protocol-specific prerequisites.

Group III: Study 2: High Dose InductionExperimental Treatment2 Interventions

Participants receive high dose IV tulisokibart.

Group IV: Study 2: High Dose ExtensionExperimental Treatment1 Intervention

Participants receive a high dose SC tulisokibart regimen. Participants may be enrolled in this arm only after completing participation in their original arm, if they meet protocol-specific prerequisites.

Group V: Study 1: Low Dose Induction, Low Dose MaintenanceExperimental Treatment3 Interventions

Participants receive low dose IV tulisokibart, followed by a low dose SC tulisokibart regimen.

Group VI: Study 1: Low Dose ExtensionExperimental Treatment2 Interventions

Participants receive a low dose SC tulisokibart and placebo regimen. Participants may be enrolled in this arm after completing participation in their original arm, if they meet protocol-specific prerequisites.

Group VII: Study 1: High Dose Induction, Low Dose MaintenanceExperimental Treatment3 Interventions

Participants receive high dose IV tulisokibart, followed by a low dose SC tulisokibart regimen.

Group VIII: Study 1: High Dose Induction, High Dose MaintenanceExperimental Treatment2 Interventions

Participants receive high dose intravenous (IV) tulisokibart, followed by a high dose subcutaneous (SC) tulisokibart regimen.

Group IX: Study 1: High Dose ExtensionExperimental Treatment1 Intervention

Participants receive a high dose SC tulisokibart regimen. Participants may be enrolled in this arm after completing participation in their original arm, if they meet protocol-specific prerequisites.

Group X: Study 2: PlaceboPlacebo Group3 Interventions

Participants receive IV placebo.

Group XI: Study 1: PlaceboPlacebo Group3 Interventions

Participants receive IV placebo, followed by an SC placebo regimen.

0 / 14Eligibility criteria met