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Dr . Janssen UK Registry
JanssenUKRegistryQueries@its.jnj.com


Prof Daniel Gaya


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Be Part of Research - Trial Details - A Study of Icotrokinra in participants with moderately to severely active Crohn's disease
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A Study of Icotrokinra in participants with moderately to severely active Crohn's disease

Recruiting

Open to: All Genders

Age: Mixed

London Cambridge Glasgow London Birmingham Prescot Stockport London Bury

Medical Conditions

Moderate to Severe Crohn's disease, Plaque psoriasis

This information is provided directly by researchers, and we recognise that it isn't always easy to understand. We are working with researchers to improve the accessibility of this information. In some summaries, you may come across links to external websites. These websites will have more information to help you better understand the study.


Crohn’s Disease (CD) is a disease of the digestive system that causes inflammation and ulcers in the intestine (gut).
Although there are approved treatment options, participants either do not respond or may not tolerate them due to side effects. Hence, there is a need for better treatment options.
Icotrokinra (JNJ-77242113) targets interleukin-23 (IL-23R) to prevent IL-23* from binding to its receptor**. Blocking this protein helps to reduce inflammation.
*Protein involved in inflammation
**Protein that binds to a specific molecule
Researchers want to assess how well icotrokinra works when compared to placebo (treatment with no medical effect).

Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.  

The recruitment start and end dates are as follows:

01 Nov 2025 01 Aug 2027

Overall study consists of 3 separate studies as below:
o Phase 2b Induction Dose-ranging Study (Induction Study 1)
o Phase 3 Induction Study (Induction Study 2)
o Phase 3 Maintenance Study
Study consists of:
o Screening period (up to 6 weeks)
o Induction Study periods: Daily dosing from Week I-0 to Week I-12
o Induction Study 1:
o Icotrokinra Dose 1
o Icotrokinra Dose 2
o Placebo
o Induction Study 2:
o Icotrokinra: As per dose from induction study 1
o Placebo
o Maintenance Study: Daily dosing from Week M-0 to Week M-40. Responder participants from induction study 1 and 2 will receive either:
o Icotrokinra Dose 1
o Icotrokinra Dose 2
o Placebo
- Responder participants who show loss of response during the maintenance study will be eligible for dose adjustment to icotrokinra
- Non-responder participants will receive icotrokinra dose 2, and will be reassessed at week M-12 and continue in the study if in response.
o Long term extension study period: Daily dosing up to Week M-248.
o Safety follow-up period (up to 4 weeks after last dose of study treatment)
Safety assessments include adverse events, physical examinations, vital signs, electrocardiogram, clinical laboratory tests, suicide assessments, and tuberculosis screening. The duration of the study will be approximately 5 years.


Participants aged 18 years or older with moderate to severely active CD.

You can take part if:



You may not be able to take part if:


1. 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/orcould impair the use of instruments (such as CDAI) to assess response to study intervention2. Presence of a stoma or ostomy3. Participants with presence of active fistulas may be included if there is no surgery needed4. Colonic resection within 24 weeks before baseline or any other major surgery performed within 12 weeks before baseline5. Presence on screening colonoscopy of adenomatous colon polyps outside of an area of known colitis not removed before randomization


Below are the locations for where you can take part in the trial. Please note that not all sites may be open.

  • Whipps Cross University Hospital
    Whipps Cross Road Leytonstone
    London
    E11 1NR
  • Addenbrookes
    Addenbrookes Hospital Hills Road
    Cambridge
    CB2 0QQ
  • Glasgow Royal Infirmary
    84 Castle Street
    Glasgow
    G4 0SF
  • Guys Hospital
    Guys Hospital Great Maze Pond
    London
    SE1 9RT
  • Queen Elizabeth Hospital
    Queen Elizabeth Medical Centre Edgbaston
    Birmingham
    B15 2TH
  • Whiston Hospital
    St. Helens & Knowsley Hospital Warrington Road
    Prescot
    L35 5DR
  • Stepping Hill Hospital
    Stockport NHS Foundation Trust Stepping Hill Hospital Poplar Grove
    Stockport
    SK2 7JE
  • St George's University Hospitals NHS Foundation Trust
    Cranmer Terrace, Clinical Research Facility, Corridor 4 Jenner Wing
    London
    SW17 0RE
  • Fairfield General Hospital
    Ward 19 Clinical Research Unit Rochdale Old Road
    Bury
    BL9 7TD

There is no established benefit to participants of this study. Based on scientific theory, taking icotrokinra may improve CD. However, this cannot be guaranteed because icotrokinra is still under investigation as a treatment and it is not known whether icotrokinra will work.
In addition, if participants are put into the placebo treatment group they may not receive icotrokinra and may only receive placebo during this study unless specified.
Participants may experience some benefit from participation in the study that is not due to receiving study drug, but due to regular visits and assessments monitoring overall health. Participation may help other people with CD in the future.
Participants may have side effects from the drugs or procedures used in this study that may be mild to severe and even life-threatening, and they can vary from person to person. Potential risks include hypersensitivity (exaggerated immune response) reactions, anti-drug antibody (ADA) antibodies developed against drugs reducing their therapeutic efficacy) production and infections after getting the study drug or placebo.
Risks due to study procedure include video ileocolonoscopy (complete colonoscopy; procedure for examining parts of intestine and colon using tube called colonoscope), including bleeding, post procedure discomfort or intestinal perforation (formation of holes in
intestine) after the procedure. There are other, less frequent risks. The participant information sheet and informed consent form, which will be signed by every participant agreeing to participate in the study, includes a detailed section outlining the known risks to participating in the study.
Not all possible side effects and risks related to icotrokinra are known at this moment. During the study, the sponsor may learn new information about icotrokinra. The study doctor will tell participants as soon as possible about any new information that might make them change their mind about being in the study, such as new risks.
To minimise the risk associated with taking part in the study, participants are frequently reviewed for any side effects and other medical events. Participants are educated to report any such events to their study doctor who will provide appropriate medical care. Any serious side effects that are reported to the sponsor are thoroughly reviewed by a specialist drug safety team.
There are no costs to participants to be in the study. The sponsor will pay for the study drug and tests that are part of the study. The participant will receive reasonable reimbursement for study related costs (e.g., travel/parking costs).

Dr . Janssen UK Registry
JanssenUKRegistryQueries@its.jnj.com


Prof Daniel Gaya



The study is sponsored by Janssen-Cilag International N.V. and funded by Janssen Research and Development.



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Read full details for Trial ID: ISRCTN15911581

Or CPMS: 67835

Last updated 13 November 2025

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