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)
- How long the study runs
- Study runs about 59 months (dates as stated)
- About the drug or intervention
- Afimkibart — drug: Afimkibart will be administered as IV infusion.
- Patient visit burden
- Not specified by the sponsor
- Type of study
- Testing a treatment
- Ages
- 2 Years to 17 Years
- Who
- All
- Number of participants
- 100
- Started
- 2026-04-15
- Last checked
- 2026-10
Plain English Summary
What is this study?
- • Testing a new treatment for moderately to severely active ulcerative colitis
- • Phase3 - 100 participants
- • This Phase III, randomized, double-blind, multicenter, induction and maintenance study will evaluate the safety and efficacy of Afimkibart (RO7790121) in pediatric participants with moderate to severe active ulcerative colitis (UC)
Who can take part?
- • Ages 2 Years to 17 Years
- • Diagnosed with moderately to severely active ulcerative colitis
Where?
- • Birmingham - Birmingham Children's Hospital
- • Cambridge - Addenbrooke's Hospital
- • Sheffield - Sheffield Childrens Hospital
This is a simplified summary. Always discuss with your doctor before making any decisions.
About This Trial
This Phase III, randomized, double-blind, multicenter, induction and maintenance study will evaluate the safety and efficacy of Afimkibart (RO7790121) in pediatric participants with moderate to severe active ulcerative colitis (UC).
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: 2 Years - 17 Years
- Who can join: All genders
Biomarkers mentioned
What the study is looking for
- ✓Bodyweight \>= 10 kilogram (kg)
- ✓Confirmed diagnosis of UC
Who cannot take part
- ✗Monogenic disorder pertaining to infant onset inflammatory bowel disease (IBD)
- ✗Presence of an ostomy or ileoanal pouch
- ✗Current diagnosis or suspicion of primary sclerosing cholangitis
- ✗Any major surgery within 6 weeks prior to screening or a major planned surgery during the study
- ✗Active tuberculosis (TB) infection suggested by positive TB testing, clinical symptoms, and/or chest imaging (X-ray...
See the full criteria
Where Is This Study? (3 UK sites)
Birmingham Children's Hospital
Birmingham B4 6NH, United Kingdom
Addenbrooke's Hospital
Cambridge CB2 0QQ, United Kingdom
Sheffield Childrens Hospital
Sheffield S10 2TH, United Kingdom
How to Get in Touch
Reference Study ID Number: CA45905 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
