Recruiting NCT06819878

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

Phase III Interventional Moderately to Severely Active Crohns Disease

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 Crohns Disease. 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 +33
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, 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

Overview

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

Interventions

Drug Afimkibart
Afimkibart will be administered as IV infusion. Afimkibart will be administered as SC injection.
Drug Placebo
Placebo matching IV afimkibart. Placebo matching SC afimkibart.

Primary outcome measures

Percentage of Participants with Clinical Remission per Crohn's Disease Activity Index (CDAI) Score [Time frame: At Week 52]
Percentage of Participants with Endoscopic Response [Time frame: At Week 52]

Secondary outcome measures (12)

Percentage of Participants with Clinical Remission [Time frame: At Week 12]
Percentage of Participants with Endoscopic Response [Time frame: At Week 12]
Percentage of Participants with Symptomatic Remission [Time frame: At Week 12]
Percentage of Participants with Endoscopic Remission [Time frame: At Week 12]
Percentage of Participants with Ulcer-free Endoscopy [Time frame: At Week 12]
Average of Daily Number of Liquid or Very Soft Stools in the Past Week (SF) [Time frame: Baseline through Week 12]
Average of Daily Abdominal Pain Scores in the Past Week (APS) [Time frame: Baseline through Week 12]
Percentage of Participants with Endoscopic Remission [Time frame: At Week 52]
Percentage of Participants with Symptomatic Remission [Time frame: At Week 52]
Percentage of Participants with Corticosteroid-free Clinical Remission [Time frame: At Week 52]
Maintenance of Clinical Remission [Time frame: At Weeks 12 and 52]
Maintenance of Endoscopic Response [Time frame: At Weeks 12 and 52]

Eligibility 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, enterovaginal, high output enterocutaneous fistula, enterovesical 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
Any past or current evidence of cancer of gastrointestinal tract, definite low-grade or high-grade colonic dysplasia
History of non-gastrointestinal cancer, with the exception of adequately treated non-metastatic basal cell or squamous cell skin 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) during screening
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