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NCT06819891 | RECRUITING | Moderately to Severely Active Crohns Disease

A Study to Assess the Efficacy and Safety of Induction Therapy With RO7790121 in Participants With Moderately to Severely Active Crohn's Disease
Sponsor:

Hoffmann-La Roche

Brief Summary:

This Phase III, multicenter, double-blind, placebo-controlled study will evaluate the efficacy and safety of induction therapy with RO7790121 in participants with moderately to severely active Crohn's disease (CD).

Condition or disease

Moderately to Severely Active Crohns Disease

Intervention/treatment

RO7790121

Placebo

Phase

PHASE3

Study Type : INTERVENTIONAL
Estimated Enrollment : 425 participants
Masking : DOUBLE
Primary Purpose : TREATMENT
Official Title : A Phase III, Multicenter, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of Induction Therapy With RO7790121 in Patients With Moderately to Severely Active Crohn's Disease
Actual Study Start Date : 2025-05-09
Estimated Primary Completion Date : 2028-12-31
Estimated Study Completion Date : 2028-12-31

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 16 Years to 80 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
Inclusion Criteria
  • * Confirmed diagnosis of CD
  • * Moderately to severely active CD
  • * Bodyweight \>= 40 kilogram (kg)
  • * Demonstrated inadequate response, loss of response and/or intolerance to at least one protocol-specified conventional or advanced CD therapy
  • * Males and females of childbearing potential must meet protocol criteria for contraception requirements
Exclusion Criteria
  • * Current diagnosis of ulcerative colitis (UC) or indeterminate colitis, ischemic colitis, infectious colitis, radiation colitis, microscopic colitis
  • * Participant with a history of \>= 3 bowel resections (\> 2 missing segments of the 5 following segments: terminal ilelium, right colon, transverse colon, sigmoid and left colon, and rectum)
  • * Diagnosis of short gut or short bowel syndrome
  • * Presence of an ileostomy, colostomy or ileoanal pouch
  • * Participants with symptomatic bowel strictures, fulminant colitis, or toxic megacolon
  • * Presence of abdominal or perianal abscess
  • * Presence of rectovaginal fistulas or perianal fistulas with \>3 openings
  • * Participants with symptomatic bowel strictures, fulminant colitis, or toxic megacolon
  • * Current diagnosis or suspicion of primary sclerosing cholangitis
  • * Pregnancy or breastfeeding, or intention of becoming pregnant during the study
  • * Past or current evidence of definite low-grade or high-grade colonic dysplasia or adenomas or neoplasia not completely removed
  • * History of malignancy within 5 years, with the exception of malignancies adequately treated with resection for non-metastatic basal cell or squamous cell cancer or in situ cervical cancer
  • * Evidence of infection with Clostridioides difficile (C. difficile; formerly known as Clostridium difficile), cytomegalovirus (CMV), human immunodeficiency virus (HIV), Hepatitis B (HBV), Hepatitis C (HCV)
  • * Has evidence of active tuberculosis (TB), latent TB not successfully treated (per local guidance) or inadequately treated TB
  • * Has received protocol-specified prohibited medicines, including known exposure to any type of anti-TL1A therapy
A Study to Assess the Efficacy and Safety of Induction Therapy With RO7790121 in Participants With Moderately to Severely Active Crohn's Disease

Location Details

NCT06819891

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How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

RECRUITING

United States, Florida

J&A Clinical Research

Doral, Florida, United States, 33173

RECRUITING

United States, Florida

Allied Biomedical Research Institute, Inc

Miami, Florida, United States, 33155

RECRUITING

United States, Florida

Eminat Research Group

Miramar, Florida, United States, 33027

RECRUITING

United States, Florida

Digestive and Liver Center of Florida

Orlando, Florida, United States, 32825

RECRUITING

United States, North Carolina

Charlotte Gastroenterology and Hepatology, P.L.L.C

Charlotte, North Carolina, United States, 28207

RECRUITING

Australia, New South Wales

Macquarie University Hospital

Macquarie Park, New South Wales, Australia, 2109

RECRUITING

Australia, Queensland

Coral Sea Clinical Research Institute

Mackay, Queensland, Australia, 4740

RECRUITING

China, Jiangxi

First Affiliated Hospital of Gannan Medical University

Ganzhou, Jiangxi, China, 341000

RECRUITING

China,

Beijing Union Hospital

Beijing, China, 100730

RECRUITING

China,

Sichuan Provincial People's Hospital

Chengdu, China, 610072

RECRUITING

China,

Guangzhou First People's Hospital

Guangzhou, China, 510180

RECRUITING

China,

Zhujiang Hospital, Southern Medical University

Guangzhou, China, 510280

RECRUITING

China,

Huizhou First Hospital

Huizhou, China, DUMMY_VALUE

RECRUITING

China,

Jinhua municipal central hospital

Jinhua, China, DUMMY_VALUE

RECRUITING

China,

The Second Affiliated Hospital of Nanchang University

Nanchang City, China, 330008

RECRUITING

China,

Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine

Shanghai, China, 200092

RECRUITING

China,

Shengjing Hospital of China Medical University

ShenYang, China, 110004

RECRUITING

China,

Hebei Medical University - The Second Hospital

Shijiazhuang city, China, 050004

RECRUITING

China,

Affiliated Hospital of Jiangsu University

Zhenjiang, China, 212001

RECRUITING

Colombia,

San Ignacio University Hospital

Bogota, Colombia, 000472

RECRUITING

Colombia,

Oncomedica S.A.

Monteria, Colombia, 230002

RECRUITING

United Kingdom,

Royal London Hospital

London, United Kingdom, E1 1FR