A Study to Assess the Efficacy and Safety of Induction Therapy With Afimkibart (RO7790121) in Par… (NCT06819891) | Clinical Trial Compass
RecruitingPhase 3
A Study to Assess the Efficacy and Safety of Induction Therapy With Afimkibart (RO7790121) in Participants With Moderately to Severely Active Crohn's Disease
United States425 participantsStarted 2025-05-12
Plain-language summary
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).
Who can participate
Age range16 Years – 80 Years
SexALL
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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 ca…
What they're measuring
1
Percentage of Participants with Clinical Remission per Crohn's Disease Activity Index (CDAI) Score
Timeframe: At Week 12
2
Percentage of Participants with Endoscopic Response
Timeframe: At Week 12
Trial details
NCT IDNCT06819891
SponsorHoffmann-La Roche
Sponsor typeINDUSTRY
Study typeINTERVENTIONAL
Primary completion2028-12-31
Contact for this trial
Reference Study ID Number: GA45332 https://forpatients.roche.com/