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).
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? (8 UK sites)
Addenbrookes Hospital
Cambridge CB2 0QQ, United Kingdom
St Mark's Hospital & Imperial College
Harrow HA1 3UJ, United Kingdom
Royal Liverpool University Hospital
Liverpool L7 8XP, United Kingdom
King College Hospital NHS Foundation Trust
London SE5 9RS, United Kingdom
Queen Anne Street Medical Centre
London W1T 6AH, United Kingdom
Royal Victoria Infirmary
Newcastle upon Tyne NE1 4LP, United Kingdom
North Tyneside General Hospital
North Shields NE29 8NH, United Kingdom
Research and Development
researchanddevelopment@nhct.nhs.uk0191 2934087Nottingham University Hospitals Queen's Medical Centre
Nottingham NG7 2UH, United Kingdom
How to Get in Touch
Reference Study ID Number: GA45331 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
