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Looking for participantsPhase3

A Protocol of Icotrokinra Therapy in Adult and Adolescent Participants With Moderately to Severely Active Ulcerative Colitis

Sponsor: Janssen Research & Development, LLC

NCT ID: NCT07196748

View on ClinicalTrials.gov ↗

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).

Colitis, Ulcerative

How this trial compares with your answers

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What we know so far

Condition· Matched your search
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Still need:

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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

have a negativeand a negative

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
Inclusion Criteria: * Diagnosis of ulcerative colitis (UC) established at least 12 weeks before screening including both endoscopic evidence and a histopathology report consistent with a diagnosis of UC * Moderately to severely active UC, defined as a baseline (Week I-0) modified Mayo score of 5 to 9, inclusive, using the endoscopy subscore obtained during the central review of the screening video endoscopy * An endoscopy subscore greater than or equal to (\>=) 2 as obtained during central review of the screening video endoscopy * Adolescent Participants: body weight must be \>= 40 kilograms (kg) at baseline (Week I-0) * Adult female participants of childbearing potential and all adolescent female participants must have a negative highly sensitive serum pregnancy test (beta-human chorionic gonadotropin \[β-hCG\]) at screening and a negative urine pregnancy test at Week I-0 prior to administration of study intervention and agree to further pregnancy tests * Demonstrated an inadequate response to, or failure to tolerate conventional therapy but are naïve to advanced therapies (ADT naïve), or inadequate response to (that is, primary or secondary nonresponse) or failure to tolerate advanced therapy defined as biologics and/or advanced oral agents for the treatment of UC (ADT-inadequate responder \[IR\]) as defined in the protocol Exclusion Criteria: * Participants with current known complications of UC such as fulminant colitis, toxic megacolon, or any other manifestation that might require colonic surgery while enrolled in the study * 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 within 12 weeks before baseline * History of extensive colonic resection (that is, less than \[\<\] 30 centimeter \[cm\] of colon remaining) or colonic resection that could impair the use of disease severity assessments (for example Mayo Score) to assess response to study intervention

Where Is This Study? (9 UK sites)

Addenbrooke's Hospital

Cambridge CB2 0QQ, United Kingdom

Recruiting
Hospital R&D contact (matched)

Stephen Kelleher

cuh.research@nhs.net01223 348490

Royal Hospital for Children and Young People

Edinburgh EH16 4TJ, United Kingdom

Recruiting

Fairfield General Hospital

Greater Manchester BL9 7TD, United Kingdom

Recruiting

Whipps Cross University Hospital

London E11 1NR, United Kingdom

Recruiting

Kings College Hospital

London SE5 9RS, United Kingdom

Recruiting
Hospital R&D contact (matched)

Jasmine Palmer

kch-tr.research@nhs.net0203 299 1980

St Georges University Hospitals NHS Foundation Trust

London SW17 0QT, United Kingdom

Recruiting
Hospital R&D contact (matched)

Mr Subhir Bedi

researchgovernance@sgul.ac.uk020 8725 4986

Whiston Hospital

Rainhill L35 5DR, United Kingdom

Recruiting

Sheffield Children's Hospital

Sheffield S10 2TH, United Kingdom

Recruiting
Hospital R&D contact (matched)

Alessia Dunn

STH.ResearchAdministration@nhs.net0114 2712550

Stepping Hill Hospital

Stockport SK2 7JE, United Kingdom

Recruiting
Hospital R&D contact (matched)

Research, Development & Innovation Office

research.development@stockport.nhs.uk0161 419 5893

How to Get in Touch

Study Contact

Sponsor contact

CONTACT

844-434-4210 Participate-In-This-Study1@its.jnj.com
Data sourced from ClinicalTrials.gov · Last verified: 2026-09