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Looking for participantsPhase2/Phase3

A Study of Icotrokinra in Participants With Moderately to Severely Active Crohn's Disease

Sponsor: Janssen Research & Development, LLC

NCT ID: NCT07196722

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 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).

Crohn Disease

How this trial compares with your answers

Answer 2 more questions to improve match

What we know so far

Condition· Matched your search
Age· Tell us your age for better matching
Gender· Tell us your sex for better matching

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

have a negativeand a negative

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
Inclusion Criteria: * Diagnosis of CD established at least 12 weeks before screening including both endoscopic evidence and a histopathology report consistent with a diagnosis of CD * Moderately to severely active CD based on CDAI criteria, defined as baseline (Week I-0) CDAI score \>=220 but \<=450 and either mean daily SF count \>=4, or mean daily AP score \>=2 * Moderately to severely active CD based on SES-CD criteria assessed by baseline (Week I-0) endoscopic evidence of active ileal and/or colonic CD as assessed during central review of the screening video ileocolonoscopy defined as a SES-CD \>= 6 for participants with colonic or ileocolonic disease, and SES-CD \>= 4 for participants with isolated ileal disease, based on the presence of ulceration in any 1 of the 5 ileocolonic segments * A female participant of childbearing potential must have a negative highly sensitive serum pregnancy test (beta-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 naïve to advanced therapies (advanced drug therapy \[ADT\]-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 CD- (ADT-inadequate responder \[IR\]) as defined in the protocol Exclusion criteria: * Has complications of CD, such as symptomatic strictures or stenoses, short gut syndrome, or any other manifestation, that may require surgery while enrolled in the study and/or could impair the use of instruments (such as CDAI) to assess response to study intervention * 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 randomization

Where Is This Study? (9 UK sites)

Queen Elizabeth Hospital Birmingham

Birmingham B15 2GW, United Kingdom

Recruiting
Hospital R&D contact (matched)

Sarah Pountain Head of Research Governance

R&D@uhb.nhs.uk0121 371 4185

Addenbrooke's Hospital

Cambridge CB2 0QQ, United Kingdom

Recruiting
Hospital R&D contact (matched)

Stephen Kelleher

cuh.research@nhs.net01223 348490

Glasgow Royal Infirmary

Glasgow G31 2ER, United Kingdom

Recruiting
Hospital R&D contact (matched)

Colleen Bowthorpe

colleen.bowthorpe@nhs.scot01387 241815

Fairfield General Hospital

Greater Manchester BL9 7TD, United Kingdom

Recruiting

Whipps Cross University Hospital

London E11 1NR, United Kingdom

Recruiting

Guy's Hospital

London SE1 9RT, United Kingdom

Recruiting
Hospital R&D contact (matched)

Main Email: gstt.research.rbhh@nhs.net

gstt.research.rbhh@nhs.netn/a

St Georges University Hospital NHS Foundation Trust

London SW17 0RE, 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

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