Last updated 13 days ago

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, Argentina, Peru, Mexico

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

23Research 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 80 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

Paseo Bulnes 79, oficina 27, Santiago, Región Metropolitana

FALP-UIDO

Recruiting

Antonio Varas 621, 7500966 Providencia, Región Metropolitana, Chile

Espacio EME

Recruiting

Av. Ricardo Lyon 2911, Ñuñoa Región Metropolitana

Hospital Dr. Hernán Henríquez Aravena

Recruiting

Manuel Montt 115, Temuco 4780000 - Araucanía

Centro de Investigaciones Clínicas Viña Del Mar

Recruiting

Anabaena 336, Viña del Mar, Valparaíso

Hospital Clínico Regional de Concepción Dr. Guillermo Grant Benavente - Concepción, Chile

Recruiting

San Martín 1436, Concepción, Bío Bío

Clínica Alemana - Chile

Recruiting

Av. Vitacura 5951, Vitacura, Región Metropolitana, Santiago

Fundación Santa Fe de Bogotá

Recruiting

calle 119 #7 75, Bogotá

Salud SURA Industriales

Recruiting

Cra. 48 #26-50, El Poblado, Medellín, El Poblado, Medellín, Antioquia, Colombia

Oncólogos del Occidente - Risaralda

Recruiting

Clínica de Alta Tecnología Maraya Cll 50 No 13-10, Pereira, Risaralda

StudyMK-7240-008

SponsorMerck Sharp & Dohme LLC

Study typeInterventional

Conditions

Crohn's diseaseModerate to severe crohn's disease

Requirements

To 80 YearsAll Gender

Unique study IDclinicaltrials.gov

NCT06430801