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Contact Information:

Dr Clinical Trials Information
-
RA-RNDUS-ClnclTrlsEU@its.jnj.com


Dr Kamal Patel
+44 7508471362
kamal.patel@stgeorges.nhs.uk


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Be Part of Research - Trial Details - A study of guselkumab in participants with fistulizing, perianal Crohn’s disease
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A study of guselkumab in participants with fistulizing, perianal Crohn’s disease

Recruiting

Open to: All Genders

Age: Adult

Newcastle upon Tyne Birmingham Hull London London Bury Belfast Harrow

Medical Conditions

Fistulizing Crohn's disease, perianal Crohn's disease

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 is a chronic inflammatory disease that can affect any part of the digestive tract. It causes inflammation in lining of digestive tract and development of ulcers. A major complication of Crohn’s disease are perianal fistulas (infected tunnels develop between skin and digestive tract at end of the latter).

Guselkumab is a medicine that targets interleukin (IL)-23*and blocks it from binding to its receptor (protein that binds to specific molecule). By blocking the effects of IL-23, inflammation is reduced thus preventing disease from worsening.

*Specific protein involved in inflammation.

This study is designed to see if guselkumab is effective and safe for treatment of fistulizing, perianal Crohn’s disease.

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:

29 Apr 2022 12 Feb 2025

The study will be conducted in 3 phases:
1. Screening (Up to 6 weeks)
2. Treatment (Up to 48 weeks): Participants will be randomly (like flip of coin) divided into 3 groups to receive the treatment.

• Group 1: Guselkumab Dose 1 as an injection in vein at the beginning followed by Dose 1 as an injection under skin afterwards.
• Group 2: Guselkumab Dose 1 as an injection in vein at the beginning followed by guselkumab Dose 2 injection under skin afterwards.
• Group 3: Placebo as an injection in vein at the beginning followed by an injection under skin afterwards. Participants who respond to placebo will continue this and the ones who don’t respond will start receiving guselkumab Dose 3 followed by Dose 1 as injection under skin afterwards.

Participants who complete assessment at Week 48 may have option to participate in long-term extension phase and will receive guselkumab until Week 96.

3. Safety follow-up (Up to Week 64)

During study visits a variety of tests will be carried out including but not limited to, blood tests, MRI, questionnaires, vital signs, and suicidality assessments. All side effects will be recorded until study ends (Up to 118 weeks).


Study will include male and female participants 18 years and older with fistulizing, perianal Crohn’s disease.

You can take part if:



You may not be able to take part if:


1. Has a very severe luminal disease activity2. History of or concurrent rectovaginal fistulas, rectal and/or anal stenosis or other active complications of perianal disease3. Has complications of CD, such as symptomatic strictures or stenoses, short gut syndrome, or any other manifestation that might be anticipated to require surgery or preclude fistula evaluation4. Any medical contraindications preventing study participation5. Has a history of ongoing, chronic or recurrent enteral or systemic infectious disease


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

  • Royal Victoria Infirmary
    Queen Victoria Road
    Newcastle upon Tyne
    NE1 4LP
  • Queen Elizabeth Hospital
    Mindelsohn Way Edgbaston
    Birmingham
    B15 2GW
  • Hull Royal Infirmary
    Anlaby Road
    Hull
    HU3 2JZ
  • St Georges Hospital
    Blackshaw Road
    London
    SW17 0QT
  • Guy's & St Thomas Hospital
    Westminster Bridge Road
    London
    SE1 7EH
  • Fairfield General Hospital
    Fairfield General Hospital Rochdale Old Road
    Bury
    BL9 7TD
  • Ulster Hospital
    Upper Newtownards Rd Dundonald
    Belfast
    BT16 1RH
  • St Marks Hospital
    Watford Road
    Harrow
    HA1 3UJ

There is no established benefit to participants of this study. Based on scientific theory, taking guselkumab may improve fistulizing, perianal Crohn's disease. However, this cannot be guaranteed because guselkumab is still under investigation as a treatment and it is not known whether guselkumab will work.
If participants are put into the placebo treatment group, they will not receive guselkumab until they are not responding to placebo. (Participants who don’t respond to placebo, will start receiving guselkumab.)
Participants may experience some benefit from participation in the study that is not due to receiving study drug itself, but due to regular visits and assessments monitoring overall health. Participation may help other people with fistulizing, perianal Crohn's disease 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. The most common, known risks are getting symptoms such as serious infections and reactivation of latent infections, hypersensitivity reactions, including serious hypersensitivity reactions, liver injury, and malignancy after getting the study drug. 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 guselkumab are known at this moment. During the study, the sponsor may learn new information about guselkumab. 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 minimize 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 the 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 Clinical Trials Information
-
RA-RNDUS-ClnclTrlsEU@its.jnj.com


Dr Kamal Patel
+44 7508471362
kamal.patel@stgeorges.nhs.uk



The study is sponsored by Janssen-Cilag International NV and funded by Janssen-Cilag Limited.



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Read full details for Trial ID: ISRCTN15970897

Or CPMS 52671

Last updated 08 April 2024

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