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Looking for participantsPhase3

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

Sponsor: Hoffmann-La Roche

NCT ID: NCT06819878

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 105 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
600
Started
2025-03-17
Last checked
2026-09

Plain English Summary

What is this study?

  • • Testing a new treatment for moderately to severely active crohns disease
  • • Phase3 - 600 participants
  • • This Phase III, multicenter, double-blind, placebo-controlled treat-through study will evaluate the efficacy and safety of induction and maintenance 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?

  • • Cambridge - Addenbrookes Hospital
  • • Harrow - St Mark's Hospital & Imperial College
  • • Liverpool - Royal Liverpool University Hospital
  • • London - King College Hospital NHS Foundation Trust
  • • +4 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 treat-through study will evaluate the efficacy and safety of induction and maintenance 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 * 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

Where Is This Study? (8 UK sites)

Addenbrookes Hospital

Cambridge CB2 0QQ, United Kingdom

Recruiting
Hospital R&D contact (matched)

Stephen Kelleher

cuh.research@nhs.net01223 348490

St Mark's Hospital & Imperial College

Harrow HA1 3UJ, United Kingdom

Recruiting
Hospital R&D contact (matched)

Donna Copeland

donna.copeland@nhs.net---

Royal Liverpool University Hospital

Liverpool L7 8XP, United Kingdom

Recruiting

King College Hospital NHS Foundation Trust

London SE5 9RS, United Kingdom

Recruiting

Queen Anne Street Medical Centre

London W1T 6AH, United Kingdom

WITHDRAWN

Royal Victoria Infirmary

Newcastle upon Tyne NE1 4LP, United Kingdom

Recruiting
Hospital R&D contact (matched)

Colleen Bowthorpe

colleen.bowthorpe@nhs.scot01387 241815

North Tyneside General Hospital

North Shields NE29 8NH, United Kingdom

Recruiting
Hospital R&D contact (matched)

Research and Development

researchanddevelopment@nhct.nhs.uk0191 2934087

Nottingham University Hospitals Queen's Medical Centre

Nottingham NG7 2UH, United Kingdom

Recruiting
Hospital R&D contact (matched)

Alison Lloyd

nuhnt.researchsponsor@nhs.net0115 9249924

How to Get in Touch

Reference Study ID Number: GA45331 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