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Study of Afimkibart for Moderately to Severely Active Crohn's Disease

This study is looking at a new treatment called Afimkibart (also known as RO7790121) for people with moderately to severely active Crohn's disease (CD). Researchers want to see how well Afimkibart works and if it is safe. You might receive Afimkibart, given as an IV infusion or a shot under the skin, or a placebo (an inactive substance that looks like the study drug). To join, you need to be 16 to 80 years old, weigh at least 40 kg, and have a confirmed diagnosis of CD that hasn't responded well to other treatments. The study will measure success by looking at improvements in your Crohn's disease symptoms and how your intestines look at Week 12. The study plans to enroll 425 people, but its current status is unclear.

Study design
This is a Phase III, multicenter, double-blind study, meaning neither you nor your doctor will know if you are receiving Afimkibart or a placebo. It plans to enroll 425 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The primary outcomes are measured at Week 12.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06819891

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

Recruiting
PHASE3Ages 16–80InterventionalTreatment
Hoffmann-La Roche
~425 participants
Updated 2026-08-04 on ClinicalTrials.gov
What's tested:AfimkibartPlacebo

At a glance

Recruiting sites
190 of 196 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Percentage of Participants with Clinical Remission per Crohn's Disease Activity Index (CDAI) Score
Measured over At Week 12
+1 more outcome measured

Conditions

Moderately to Severely Active Crohns Disease

Explore related trials

Crohn Disease

Where it's being run

196 sites across 74 states
Poland17
China15
Florida12
France10
Texas8
California6
Ontario5
Czechia5

Study leadership

  • Clinical Trials · STUDY_DIRECTOR · Hoffmann-La Roche

Who to contact

Reference Study ID Number: GA45332 https://forpatients.roche.com/ No attachments to email below.
[email protected]
888-662-6728 (U.S. and Canada)
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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, high-grade colonic dysplasia and participants with low-grade dysplasia are eligible if lesions have been completely removed
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

What this trial measures

  • Percentage of Participants with Clinical Remission per Crohn's Disease Activity Index (CDAI) ScoreAt Week 12

    Percentage of participants achieving a CDAI score of \<150. The index is a weighted sum of scores on eight components: number of liquid or soft stools (stool frequency), abdominal pain, general well-being, number of complications, use of anti-diarrheal medication, presence of an abdominal mass, hematocrit, and percentage deviation from standard body weight. CDAI generally ranges from 0 to roughly 600, with higher values indicating greater activity.

  • Percentage of Participants with Endoscopic ResponseAt Week 12

    Percentage of participants achieving a decrease in Simple Endoscopic Score for Crohn's Disease (SES-CD) of \>50% from baseline. The SES-CD is a composite of four features of endoscopic activity (presence and size of ulcers, extent of ulcerated surface, extent of affected and presence and type of narrowings or stenosis) in up to five ileocolonic segments (terminal ileum, right colon, transverse colon, sigmoid and left colon, and rectum). Each feature is scored on a scale from 0 to 3, giving segment subscores of 0 to 12 points and a total SES-CD range of 0-60, with a higher value indicating greater severity.