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A Study to Evaluate the Efficacy and Safety of Tulisokibart (MK-7240) in Participants With Moderate to Severe Crohn's Disease (MK-7240-008)
1200 patients around the world
Available in Chile
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.
Merck Sharp & Dohme LLC
2Research sites
1200Patients around the world
This study is for people with
Crohn's disease
Moderate to severe crohn's disease
Requirements for the patient
To 75 Years
All Gender
Medical requirements
- 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.
- 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.
Sites
Centro de Estudios Clínicos e Investigaciones Médicas CeCim
Recruiting
Espacio EME
Recruiting
SponsorMerck Sharp & Dohme LLC
Conditions
Crohn's diseaseModerate to severe crohn's disease
Requirements
To 75 YearsAll Gender
Unique study IDclinicaltrials.gov
NCT06430801
