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A PHASE III, MULTICENTER, DOUBLE-BLIND, PLACEBO-CONTROLLED, TREAT-THROUGH STUDY TO ASSESS THE EFFICACY AND SAFETY OF INDUCTION AND MAINTENANCE THERAPY WITH RO7790121 IN PATIENTS WITH MODERATELY TO SEVERELY ACTIVE ULCERATIVE COLITIS

A Study to Assess the Efficacy and Safety of RO7790121 for Induction and Maintenance Therapy in Participants With Moderately to Severely Active Ulcerative Colitis

Kun Tae Park

F. Hoffmann-La Roche

1-1 NIHONBASHI-MUROMACHI 2-CHOME, CHUO-KU, Tokyo

clinical-trials@chugai-pharm.co.jp

Clinical trials information

Chugai Pharmaceutical Co., Ltd.

1-1 NIHONBASHI-MUROMACHI 2-CHOME, CHUO-KU, Tokyo

+81-120189706

clinical-trials@chugai-pharm.co.jp

Not Recruiting

May. 01, 2025

Interventional

randomized controlled trial

double blind

placebo control

parallel assignment

treatment purpose

-Confirmed diagnosis of UC
-Moderately to severely active UC assessed by mMS
-Bodyweight >= 40 kilogram (kg)
-Demonstrated inadequate response, loss of response and/or intolerance to at least one protocol-specified conventional or advanced UC therapy
-Males and females of childbearing potential must meet protocol criteria for contraception requirements

-Currently known complications of UC (e.g. fulminant colitis, toxic megacolon)
-Current diagnosis of Crohn's disease (CD) or indeterminate colitis, microscopic colitis, ischemic colitis, infectious colitis, radiation colitis
-Presence of an ostomy or ileoanal pouch
-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

Both

Ulcerative Colitis

RO7790121: RO7790121/Placebo will be administered as IV infusion. RO7790121/Placebo will be administered as SC injection.

efficacy
-Percentage of Participants with Clinical Remission at Week 12
-Percentage of Participants with Clinical Remission at Week 52

safety, efficacy
-Percentage of Participants with Clinical Response
-Percentage of Participants with Maintenance of Remission
-Percentage of Participants with Clinical remission: Among Biomarker-Defined Subgroups of Participants
-Change in Health-Related Quality of Life
-Overall Change in UC Symptoms

+81-53-448-5121

Jan. 17, 2025

Yes

Qualified researchers may request access to individual patient level data through the clinical study data request platform. For further details on Chugai's Data Sharing Policy and how to request access to related clinical study documents, see here (www.chugai-pharm.co.jp/english/profile/rd/ctds_request.html).

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