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

This study is testing a drug called Afimkibart (also known as RO7790121) for people with moderately to severely active Crohn's disease (CD). Researchers want to see if Afimkibart is effective and safe as both an initial treatment and for ongoing maintenance. You might receive Afimkibart, given as an intravenous (IV) infusion or a subcutaneous (SC) injection, or a placebo (an inactive substance). To join, you must be 16 to 80 years old, weigh at least 40 kg, have a confirmed CD diagnosis, and your current CD treatment must not be working well enough. The study will look at how many participants achieve clinical remission and endoscopic response after 52 weeks. The current status of this study is unclear.

Study design
This is a Phase III, multicenter, double-blind, placebo-controlled study planning to enroll 600 participants. This means neither you nor your doctor will know if you are receiving Afimkibart or a placebo.
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 52, indicating follow-up for at least that duration.

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

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

Recruiting
PHASE3Ages 16–80InterventionalTreatment
Hoffmann-La Roche
~600 participants
Updated 2026-08-20 on ClinicalTrials.gov
What's tested:AfimkibartPlacebo

At a glance

Recruiting sites
361 of 373 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 52
+1 more outcome measured

Conditions

Moderately to Severely Active Crohns Disease

Explore related trials

Crohn Disease

Where it's being run

373 sites across 98 states
Japan47
China25
Poland23
Florida17
South Korea12
Texas11
Belgium10
California9

Study leadership

  • Clinical Trials · STUDY_DIRECTOR · Hoffmann-La Roche

Who to contact

Reference Study ID Number: GA45331 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
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

What this trial measures

  • Percentage of Participants with Clinical Remission per Crohn's Disease Activity Index (CDAI) ScoreAt Week 52

    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 52

    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.