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

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 Crohn's Disease

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2041250054

Enrollment

600

Registered

2025-06-30

Start date

2025-09-04

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Moderately to Severely Active Crohn's Disesase

Interventions

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

Eligibility

Sex/Gender

All

Inclusion 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

Exclusion criteria: - Current diagnosis of UC or indeterminate colitis, ischemic colitis, infectious colitis, radiation colitis, microscopic colitis - Participant with a history of >= 3 bowel resections - 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 - 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 C. difficile, CMV, HIV, HBV, HCV - Has evidence of active 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

Design outcomes

Primary

Measure	Time frame
efficacy, - Percentage of Participants with Clinical Remission per Crohn's Disease Activity Index (CDAI) Score at Week 52 - Percentage of Participants with Endoscopic Response at Week 52	—

Secondary

Measure	Time frame
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 - Bowel Urgency, Fatigue, IBDQ Score - Overall Change in CD Symptoms	—

Countries

Belgium, Canada, Chile, China, France, Japan, Mexico, Poland, Puerto Rico, United Kingdom, United States

Contacts

Public ContactClinical trials information

Chugai Pharmaceutical Co., Ltd.

clinical-trials@chugai-pharm.co.jp+81-120-189-706

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026