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).
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
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
Where Is This Study? (5 UK sites)
Southmead Hospital
Bristol BS10 5NB, United Kingdom
Fairfield General Hospital
Bury BL9 7TD, United Kingdom
Bronglais General Hospital
Llanrhystud SY23 1ER, United Kingdom
Royal London Hospital
London E1 1FR, United Kingdom
Stepping Hill Hospital
Stockport SK2 7JE, United Kingdom
Research, Development & Innovation Office
research.development@stockport.nhs.uk0161 419 5893How to Get in Touch
Reference Study ID Number: GA45332 https://forpatients.roche.com/ No attachments to email below.
Sponsor contactCONTACT
Fastest response: use the inquiry form. https://www.gene.com/contact-us/submit-medical-inquiry
Sponsor contactCONTACT
