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
- Icotrokinra (drug), Placebo (drug)
- How long the study runs
- Study runs about 75 months (dates as stated)
- About the drug or intervention
- Icotrokinra — drug: Icotrokinra tablet will be administered orally. · Placebo — drug: Placebo tablet will be administered orally.
- Patient visit burden
- Not specified by the sponsor
- Type of study
- Testing a treatment
- Ages
- 12 Years and over
- Who
- All
- Number of participants
- 882
- Started
- 2025-10-01
- Last checked
- 2026-09
Plain English Summary
What is this study?
- • Testing a new treatment for colitis, ulcerative
- • Phase3 - 882 participants
- • The purpose of this protocol is to evaluate the efficacy (how well it works), safety and tolerability of oral icotrokinra as therapy in adult and adolescent participants with moderately to severely active ulcerative colitis (UC, a chronic disease of the large intestine in which the lining of the colon becomes inflamed and develops tiny open ulcers)
Who can take part?
- • Ages 12 Years and over
- • Diagnosed with colitis, ulcerative
Where?
- • Cambridge - Addenbrooke's Hospital
- • Edinburgh - Royal Hospital for Children and Young People
- • Greater Manchester - Fairfield General Hospital
- • London - Whipps Cross University Hospital
- • +5 more UK sites
This is a simplified summary. Always discuss with your doctor before making any decisions.
About This Trial
The purpose of this protocol is to evaluate the efficacy (how well it works), safety and tolerability of oral icotrokinra as therapy in adult and adolescent participants with moderately to severely active ulcerative colitis (UC, a chronic disease of the large intestine in which the lining of the colon becomes inflamed and develops tiny open ulcers).
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: 12 Years and over
- Who can join: All genders
Biomarkers mentioned
What the study is looking for
- ✓Diagnosis of ulcerative colitis (UC) established at least 12 weeks before screening including both endoscopic...
- ✓An endoscopy subscore greater than or equal to (\>=) 2 as obtained during central review of the screening video...
- ✓Adolescent Participants: body weight must be \>= 40 kilograms (kg) at baseline (Week I-0)
Who cannot take part
- ✗Participants with current known complications of UC such as fulminant colitis, toxic megacolon, or any other...
- ✗Presence of a stoma
- ✗Presence or history of a fistula
- ✗Colonic resection within 24 weeks before baseline or any other intra-abdominal or other major surgery performed...
See the full criteria
Where Is This Study? (9 UK sites)
Addenbrooke's Hospital
Cambridge CB2 0QQ, United Kingdom
Royal Hospital for Children and Young People
Edinburgh EH16 4TJ, United Kingdom
Fairfield General Hospital
Greater Manchester BL9 7TD, United Kingdom
Whipps Cross University Hospital
London E11 1NR, United Kingdom
Kings College Hospital
London SE5 9RS, United Kingdom
St Georges University Hospitals NHS Foundation Trust
London SW17 0QT, United Kingdom
Whiston Hospital
Rainhill L35 5DR, United Kingdom
Sheffield Children's Hospital
Sheffield S10 2TH, 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
Study Contact
Sponsor contactCONTACT
