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Looking for participantsPhase3

A Study of Guselkumab Versus Risankizumab in Participants With Moderately to Severely Active Crohn's Disease

Sponsor: Janssen Research & Development, LLC

NCT ID: NCT07499232

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
Guselkumab (drug), Risankizumab (drug)
How long the study runs
Study runs about 56 months (dates as stated)
About the drug or intervention
Guselkumab — drug: Guselkumab will be administered. · Risankizumab — drug: Risankizumab will be administered.
Patient visit burden
Not specified by the sponsor
Type of study
Testing a treatment
Ages
18 Years and over
Who
All
Number of participants
530
Started
2026-04-21
Last checked
2026-09

Plain English Summary

What is this study?

  • • Testing a new treatment for crohn disease
  • • Phase3 - 530 participants
  • • The purpose of this study is to assess how well guselkumab works when compared to risankizumab 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?

  • • Greater London - Barts Health NHS Trust
  • • Greater London - London North West University Healthcare NHS Trust
  • • Iselworth - West Middlesex University Hospital
  • • London - University College London Hospitals Nhs Foundation Trust
  • • +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 assess how well guselkumab works when compared to risankizumab 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

What the study is looking for

  • ✓Has CD or fistulizing Crohn's Disease (CD) of at least 12 weeks' duration, with colitis, ileitis, or ileocolitis,...
  • ✓Have moderately to severely active CD, defined as baseline Crohn's Disease Activity Index (CDAI) score greater than...
  • ✓a minimum score of 1 for the component of "size of ulcers" AND
  • ✓a minimum score of 1 for the component of "ulcerated surface"
  • ✓In the opinion of the investigator, participant's disease is appropriate to treat with the maintenance dosing...
See the full criteria
Inclusion criteria: * Has CD or fistulizing Crohn's Disease (CD) of at least 12 weeks' duration, with colitis, ileitis, or ileocolitis, confirmed at some time in the past by radiography, histology, and/or endoscopy * Have moderately to severely active CD, defined as baseline Crohn's Disease Activity Index (CDAI) score greater than or equal to (\>=) 220 but less than or equal to (\<=) 450 * Baseline endoscopic evidence of active ileal and/or colonic CD as assessed by central endoscopy reading at the screening endoscopy defined as a screening Simple Endoscopic Score for Crohn's Disease (SES CD) \>= 4 (for participants with isolated ileal disease) or \>= 6 (for participants with colonic or ileocolonic disease), based on the presence of ulceration in any 1 of the 5 ileocolonic segments, resulting in the following specified ulceration component scores: 1. a minimum score of 1 for the component of "size of ulcers" AND 2. a minimum score of 1 for the component of "ulcerated surface" * In the opinion of the investigator, participant's disease is appropriate to treat with the maintenance dosing regimens utilized in the study * Adhere to the requirements for concomitant medications for the treatment of CD as mentioned in the protocol Exclusion criteria * Has complications of CD such as symptomatic strictures or stenoses, short gut syndrome, active draining stoma or significant fistulizing disease or any other manifestation anticipated to require surgery within the next year, could preclude the use of the CDAI to assess response to therapy, or would possibly confound the ability to assess the effect of treatment with guselkumab or risankizumab * Currently has or is suspected to have an abscess * Has an active fistula during screening or at Week 0 with an anticipated need for surgery * Has had any kind of bowel resection within 24 weeks, or any other intra-abdominal or other major surgery within 12 weeks, before first dose of study intervention * Currently has a malignancy or has a history of malignancy within 5 years before screening

Where Is This Study? (9 UK sites)

Barts Health NHS Trust

Greater London E1 2AJ, United Kingdom

Recruiting
Hospital R&D contact (matched)

Dr Mays Jawad

research.governance@qmul.ac.uk020 7882 6826

London North West University Healthcare NHS Trust

Greater London NW10 7NS, United Kingdom

Recruiting
Hospital R&D contact (matched)

Sunder Chita

Lnwh-tr.Research@nhs.net020 8869 5829

West Middlesex University Hospital

Iselworth TW7 6AF, United Kingdom

Recruiting

University College London Hospitals Nhs Foundation Trust

London NW1 2PG, United Kingdom

Recruiting
Hospital R&D contact (matched)

Rajinder Sidhu - Associate Director, Research Governance and Operations

uclh.jro-communications@nhs.net020 3447 9825

Royal Free Hospital

London NW3 2QG, United Kingdom

Recruiting
Hospital R&D contact (matched)

Natasha Ajraam

rf-tr.randd@nhs.net020 375 82150

Chelsea And Westminster Hospital

London SW10 9NH, United Kingdom

Recruiting
Hospital R&D contact (matched)

Damon Foster

damon.foster2@nhs.net020 3316 6887

Imperial College London

London W120HS, United Kingdom

Recruiting
Hospital R&D contact (matched)

Donna Copeland

donna.copeland@nhs.net---

Norfolk and Norwich University Hospital

Norwich NR4 7UQ, United Kingdom

Recruiting
Hospital R&D contact (matched)

Julie Dawson

rdsubmissions@nnuh.nhs.uk01603 286611

New Cross Hospital

Wolverhampton WV10 0QP, United Kingdom

Recruiting
Hospital R&D contact (matched)

Sarah Glover

rwh-tr.rdpmteam@nhs.net01902 695065

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