A Study to Evaluate the Efficacy and Safety of Tulisokibart (MK-7240) in Participants With Moderate to Severe Crohn's Disease (MK-7240-008)
Purpose
The purpose of this protocol is to evaluate the efficacy and safety of tulisokibart in participants with moderately to severely active Crohn's disease. Study 1's primary hypotheses are that at least 1 tulisokibart dose level is superior to Placebo in the proportion of participants achieving clinical remission per Crohn's Disease Activity Index score (<150, US/FDA) or per stool frequency and abdominal pain score (EU/EMA) and in the proportion of participants achieving endoscopic response at Week 52 (US/FDA and EU/EMA), and that at least 1 tulisokibart dose level is superior to Placebo in the proportion of participants achieving clinical remission per Crohn's Disease Activity Index score (<150, US/FDA) or per stool frequency and abdominal pain score (EU/EMA) and in the proportion of participants achieving endoscopic response at Week 12 (US/FDA and EU/EMA). Study 2's primary hypothesis is that at least 1 tulisokibart dose level is superior to Placebo in the proportion of participants achieving clinical remission per Crohn's Disease Activity Index score (<150, US/FDA) or stool frequency and abdominal pain score (EU/EMA) and in the proportion of participants achieving endoscopic response at Week 12 (US/FDA and EU/EMA).
Condition
- Crohn's Disease
Eligibility
- Eligible Ages
- Between 16 Years and 75 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Has had a diagnosis of CD at least 3 months before study. - Has moderately to severely active CD. - Demonstrated inadequate response, loss of response, or intolerance to one or more of the following categories of drugs: oral locally acting steroids, systemic steroids, immunomodulators, biologic and/or small molecule advanced therapies.
Exclusion Criteria
- 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. - Currently has any of the following complications of CD: suspected or diagnosed with intra-abdominal or perianal abscess, known symptomatic stricture or colonic stenosis not passable in endoscopy, fulminant colitis, toxic megacolon, or any other manifestation that might require surgery while enrolled in the study. - Has current stoma or need for colostomy or ileostomy. - Is missing >2 segments of the following 5 segments: terminal ileum, right colon, transverse colon, sigmoid and left colon, and rectum. - Has been diagnosed with short gut or short bowel syndrome, or any other uncontrolled chronic diarrhea besides Crohn's disease. - Has surgical bowel resection within 3 months of study. - Has prior or current gastrointestinal dysplasia. - Has chronic infection requiring ongoing antimicrobial treatment. - Has a history of cancer (except fully treated non-melanoma skin cell cancers or cervical carcinoma in situ after complete surgical removal) within the last 5 years. - Is infected with Hepatitis B virus (HBV), Hepatitis C virus (HCV), or human immunodeficiency virus (HIV). - Has active tuberculosis. - Has confirmed or suspected coronavirus disease of 2019 (COVID-19) infection. - Prior exposure to tulisokibart (MK-7240, PRA023) or another anti-anti-TL1A antibody.
Study Design
- Phase
- Phase 3
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Study 1: High Dose Induction, High Dose Maintenance |
Participants receive high dose intravenous (IV) tulisokibart, followed by a high dose subcutaneous (SC) tulisokibart regimen. |
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|
Experimental Study 1: High Dose Induction, Low Dose Maintenance |
Participants receive high dose IV tulisokibart, followed by a low dose SC tulisokibart regimen. |
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|
Experimental Study 1: Low Dose Induction, Low Dose Maintenance |
Participants receive low dose IV tulisokibart, followed by a low dose SC tulisokibart regimen. |
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|
Placebo Comparator Study 1: Placebo |
Participants receive IV placebo, followed by an SC placebo regimen. |
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Experimental Study 1: High Dose Extension |
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. |
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|
Experimental Study 1: Low Dose Extension |
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. |
|
|
Experimental Study 2: High Dose Induction |
Participants receive high dose IV tulisokibart. |
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Experimental Study 2: Low Dose Induction |
Participants receive low dose IV tulisokibart. |
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|
Placebo Comparator Study 2: Placebo |
Participants receive IV placebo. |
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|
Experimental Study 2: High Dose Extension |
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. |
|
|
Experimental Study 2: Low Dose Extension |
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. |
|
Recruiting Locations
Vanderbilt Inflammatory Bowel Disease Clinic ( Site 5049)
Nashville, Tennessee 37204
Nashville, Tennessee 37204
Contact:
Study Coordinator
615-322-2312
Study Coordinator
615-322-2312
More Details
- Status
- Recruiting
- Sponsor
- Merck Sharp & Dohme LLC
Detailed Description
The protocol consists of 2 studies. Study 1 includes induction and maintenance treatment, and Study 2 includes only induction treatment. Each study has its own hypotheses and outcome measures that will be assessed independently.