Recruiting NCT06588855

A Study to Assess the Efficacy and Safety of Induction Therapy With Afimkibart (Also Known as RO7790121) in Participants With Moderately to Severely Active Ulcerative Colitis

Phase III Interventional Moderately to Severely Active Ulcerative Colitis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied: The protocol lists: Afimkibart, Placebo.
Who it may be relevant to: Registry conditions: Moderately to Severely Active Ulcerative Colitis. Basic parameters: 16 years — 80 years · All.
What needs checking: Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place: United States, Argentina, Australia, Austria, Belgium +25
Next step: Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

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 Ulcerative Colitis

Overview

This Phase III, multicenter, double-blind, placebo-controlled study will evaluate the efficacy and safety of induction therapy with Afimkibart (RO7790121) compared with placebo in participants with moderately to severely active ulcerative colitis (UC).

Interventions

Drug Afimkibart
Participants will receive afimkibart IV followed by afimkibart subcutaneous SC injection.
Drug Placebo
Placebo matching IV afimkibart. Placebo matching SC afimkibart.

Primary outcome measures

Percentage of Participants with Clinical Remission [Time frame: At Week 12]

Secondary outcome measures (12)

Change in Partial Modified Mayo Score (pmMS) [Time frame: From baseline to Week 2]
Percentage of Participants with Endoscopic Improvement [Time frame: At Week 12]
Percentage of Participants with Endoscopic Remission [Time frame: At Week 12]
Percentage of Participants with Clinical Response [Time frame: At Week 12]
Percentage of Participants with Histologic Improvement [Time frame: At Week 12]
Percentage of Participants with Histologic Remission [Time frame: At Week 12]
Participants with Histologic-Endoscopic Mucosal Improvement [Time frame: At Week 12]
Percentage of Participants with Histologic-Endoscopic Remission [Time frame: At Week 12]
Percentage of Participants with Clinical Remission: Among Biomarker-Defined Subgroups of Participants [Time frame: At Week 12]
Percentage of Participants with Endoscopic Improvement: Among Biomarker-Defined Subgroups of Participants [Time frame: At Week 12]
Change in Bowel Urgency [Time frame: Baseline through Week 12]
Change in Abdominal Pain [Time frame: Baseline through Week 12]

Eligibility criteria

Inclusion criteria

Confirmed diagnosis of UC
Moderately to severely active UC assessed by mMS
Bodyweight >= 40 kilogram (kg)
Up to date with colorectal cancer (CRC) screening performed according to local standards
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

Exclusion criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation: Randomized
Model: Parallel assignment
Masking: Double blind
Primary purpose: Treatment