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 84 months (dates as stated)
- About the drug or intervention
- Icotrokinra — drug: Icotrokinra will be administered orally, daily. · Placebo — drug: Matching placebo will be administered orally, daily.
- Patient visit burden
- Not specified by the sponsor
- Type of study
- Testing a treatment
- Ages
- 18 Years and over
- Who
- All
- Number of participants
- 1,092
- Started
- 2025-10-03
- Last checked
- 2026-09
Plain English Summary
What is this study?
- • Testing a new treatment for crohn disease
- • Phase2/Phase3 - 1,092 participants
- • The purpose of this study is to evaluate how-well icotrokinra works (clinical efficacy) and how safe it is (safety) in participants with moderately to severely active Crohn's disease (CD; a long-term condition causing severe inflammation of the intestinal tract)
Who can take part?
- • Ages 18 Years and over
- • Diagnosed with crohn disease
Where?
- • Birmingham - Queen Elizabeth Hospital Birmingham
- • Cambridge - Addenbrooke's Hospital
- • Glasgow - Glasgow Royal Infirmary
- • Greater Manchester - Fairfield General 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 study is to evaluate how-well icotrokinra works (clinical efficacy) and how safe it is (safety) in participants with moderately to severely active Crohn's disease (CD; a long-term condition causing severe inflammation of the intestinal tract).
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: 18 Years and over
- Who can join: All genders
Biomarkers mentioned
What the study is looking for
- ✓Diagnosis of CD established at least 12 weeks before screening including both endoscopic evidence and a...
- ✓Moderately to severely active CD based on CDAI criteria, defined as baseline (Week I-0) CDAI score \>=220 but \<=450...
Who cannot take part
- ✗Presence of a stoma or ostomy
- ✗Participants with presence of active fistulas may be included if there is no surgery needed
- ✗Colonic resection within 24 weeks before baseline or any other major surgery performed within 12 weeks before baseline
- ✗Presence on screening colonoscopy of adenomatous colon polyps outside of an area of known colitis not removed before...
See the full criteria
Where Is This Study? (9 UK sites)
Queen Elizabeth Hospital Birmingham
Birmingham B15 2GW, United Kingdom
Addenbrooke's Hospital
Cambridge CB2 0QQ, United Kingdom
Glasgow Royal Infirmary
Glasgow G31 2ER, United Kingdom
Fairfield General Hospital
Greater Manchester BL9 7TD, United Kingdom
Whipps Cross University Hospital
London E11 1NR, United Kingdom
Guy's Hospital
London SE1 9RT, United Kingdom
St Georges University Hospital NHS Foundation Trust
London SW17 0RE, United Kingdom
Whiston Hospital
Rainhill L35 5DR, 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
