A Study to Assess the Efficacy and Safety of Induction Therapy With Afimkibart (RO7790121) in Participants With Moderately to Severely Active Crohn's Disease
Purpose
This Phase III, multicenter, double-blind, placebo-controlled study will evaluate the efficacy and safety of induction therapy with Afimkibart (also known as RO7790121) in participants with moderately to severely active Crohn's disease (CD).
Condition
- Moderately to Severely Active Crohns Disease
Eligibility
- Eligible Ages
- Between 16 Years and 80 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
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 - 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 - 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
Study Design
- Phase
- Phase 3
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Afimkibart |
Participants will receive afimkibart intravenously (IV) followed by afimkibart subcutaneous (SC) injection. |
|
|
Placebo Comparator Placebo |
Participants will receive placebo IV followed by afimkibart SC injection. |
|
Recruiting Locations
Vanderbilt University Medical Center
Nashville 4644585, Tennessee 4662168 37212-1375
Nashville 4644585, Tennessee 4662168 37212-1375
More Details
- Status
- Recruiting
- Sponsor
- Hoffmann-La Roche
Study Contact
Reference Study ID Number: GA45332 https://forpatients.roche.com/888-662-6728 (U.S. and Canada)
global-roche-genentech-trials@gene.com