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 73 months (dates as stated)
- About the drug or intervention
- Afimkibart — drug: Participants will receive afimkibart IV followed by afimkibart subcutaneous SC injection. · 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
- 350
- Started
- 2024-12-11
- Last checked
- 2026-10
Plain English Summary
What is this study?
- • Testing a new treatment for moderately to severely active ulcerative colitis
- • Phase3 - 350 participants
- • This Phase III, multicenter, double-blind, placebo-controlled study will evaluate the efficacy and safety of induction therapy with Afimkibart (RO7790121) compared with placebo in participants with moderately to severely active ulcerative colitis (UC)
Who can take part?
- • Ages 16 Years to 80 Years
- • Diagnosed with moderately to severely active ulcerative colitis
Where?
- • Leicester - Leicester General Hospital
- • Llanrhystud - Bronglais General Hospital
- • London - King College Hospital NHS Foundation Trust
- • Stockport - Stepping Hill Hospital
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 (RO7790121) compared with placebo in participants with moderately to severely 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: 16 Years - 80 Years
- Who can join: All genders
What the study is looking for
- ✓Confirmed diagnosis of UC
- ✓Moderately to severely active UC assessed by mMS
- ✓Bodyweight \>= 40 kilogram (kg)
- ✓Up to date with colorectal cancer (CRC) screening performed according to local standards
- ✓Demonstrated inadequate response, loss of response and/or intolerance to at least one protocol-specified...
Who cannot take part
- ✗Currently known complications of UC (e.g. fulminant colitis, toxic megacolon)
- ✗Current diagnosis of Crohn's disease (CD) or indeterminate colitis, microscopic colitis, ischemic colitis,...
- ✗Presence of an ostomy or ileoanal pouch
- ✗Current diagnosis or suspicion of primary sclerosing cholangitis
- ✗Pregnancy or breastfeeding, or intention of becoming pregnant during the study
See the full criteria
Where Is This Study? (4 UK sites)
Leicester General Hospital
Leicester LE5 4PW, United Kingdom
Carolyn Maloney
uhl-tr.researchandinnovationadminmailbox@nhs.net0116 258 8351Bronglais General Hospital
Llanrhystud SY23 1ER, United Kingdom
King College Hospital NHS Foundation Trust
London SE5 9RS, United Kingdom
Stepping Hill Hospital
Stockport SK2 7JE, United Kingdom
Research, Development & Innovation Office
research.development@stockport.nhs.uk0161 419 5893