Status:
RECRUITING
A Study to Evaluate the Efficacy and Safety of Tulisokibart (MK-7240) in Participants With Moderate to Severe Crohn's Disease (MK-7240-008)
Lead Sponsor:
Merck Sharp & Dohme LLC
Conditions:
Crohn's Disease
Eligibility:
All Genders
16-80 years
Phase:
PHASE3
Brief Summary
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...
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 wil...
Eligibility Criteria
Inclusion
- The main inclusion and exclusion criteria include but are not limited to the following:
- 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.
- Adolescent participants ≥16 and \<18 years of age can participate if approved by the country or regulatory/health authority.
Exclusion
- 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) and is disease free for \<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-TL1A antibody.
Key Trial Info
Start Date :
June 5 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 12 2029
Estimated Enrollment :
1200 Patients enrolled
Trial Details
Trial ID
NCT06430801
Start Date
June 5 2024
End Date
November 12 2029
Last Update
March 13 2026
Active Locations (497)
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1
Digestive Health Specialists ( Site 5064)
Dothan, Alabama, United States, 36301
2
Arizona Arthritis & Rheumatology Research, PC ( Site 5094)
Phoenix, Arizona, United States, 85032
3
GI Alliance - Sun City ( Site 5118)
Sun City, Arizona, United States, 85351
4
University of Arizona Clinical and Translational Sciences Research Center ( Site 5111)
Tucson, Arizona, United States, 85724