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Looking for participantsPhase3

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

Sponsor: Hoffmann-La Roche

NCT ID: NCT06819891

View on ClinicalTrials.gov ↗

At a glance

What the study gets you
Access to the study treatment being tested
Type of study
Interventional (receives a drug or procedure)
Time in hospital
In-person visits at study sites — visit count not specified by the sponsor
Drug or intervention
Afimkibart (drug), Placebo (drug)
How long the study runs
Study runs about 95 months (dates as stated)
About the drug or intervention
Afimkibart — drug: Afimkibart will be administered as IV infusion. · Placebo — drug: Placebo matching IV afimkibart.
Patient visit burden
Not specified by the sponsor
Type of study
Testing a treatment
Ages
16 Years to 80 Years
Who
All
Number of participants
425
Started
2025-05-12
Last checked
2026-09

Plain English Summary

What is this study?

  • • Testing a new treatment for moderately to severely active crohns disease
  • • Phase3 - 425 participants
  • • 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 take part?

  • • Ages 16 Years to 80 Years
  • • Diagnosed with moderately to severely active crohns disease

Where?

  • • Bristol - Southmead Hospital
  • • Bury - Fairfield General Hospital
  • • Llanrhystud - Bronglais General Hospital
  • • London - Royal London Hospital
  • • +1 more UK sites

This is a simplified summary. Always discuss with your doctor before making any decisions.

About This Trial

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).

Moderately to Severely Active Crohns Disease

How this trial compares with your answers

Answer 2 more questions to improve match

What we know so far

Condition· Matched your search
Age· Tell us your age for better matching
Gender· Tell us your sex for better matching

Still need:

  • • Tell us your age for better matching
  • • Tell us your sex for better matching

Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.

Eligibility at a Glance

Key info

  • Age: 16 Years - 80 Years
  • Who can join: All genders

What the study is looking for

  • ✓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...
  • ✓Males and females of childbearing potential must meet protocol criteria for contraception requirements

Who cannot take part

  • ✗Current diagnosis of ulcerative colitis (UC) or indeterminate colitis, ischemic colitis, infectious colitis,...
  • ✗Participant with a history of \>= 3 bowel resections (\> 2 missing segments of the 5 following segments: terminal...
  • ✗Diagnosis of short gut or short bowel syndrome
  • ✗Presence of an ileostomy, colostomy or ileoanal pouch
  • ✗Participants with causing symptoms bowel strictures, fulminant colitis, or toxic megacolon
See the full 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 * 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

Where Is This Study? (5 UK sites)

Southmead Hospital

Bristol BS10 5NB, United Kingdom

Recruiting
Hospital R&D contact (matched)

Helen Lewis-White

Research@nbt.nhs.uk0117 41 49330

Fairfield General Hospital

Bury BL9 7TD, United Kingdom

Recruiting

Bronglais General Hospital

Llanrhystud SY23 1ER, United Kingdom

Recruiting

Royal London Hospital

London E1 1FR, United Kingdom

Recruiting
Hospital R&D contact (matched)

Natasha Ajraam

rf-tr.randd@nhs.net020 375 82150

Stepping Hill Hospital

Stockport SK2 7JE, United Kingdom

ACTIVE_NOT_RECRUITING
Hospital R&D contact (matched)

Research, Development & Innovation Office

research.development@stockport.nhs.uk0161 419 5893

How to Get in Touch

Reference Study ID Number: GA45332 https://forpatients.roche.com/ No attachments to email below.

Sponsor contact

CONTACT

888-662-6728 (U.S. and Canada) global-roche-genentech-trials@gene.com

Fastest response: use the inquiry form. https://www.gene.com/contact-us/submit-medical-inquiry

Sponsor contact

CONTACT

Data sourced from ClinicalTrials.gov · Last verified: 2026-09