Crohn's Disease and Colitis Trial, Recruiting NCT07606339 Sponsor: Janssen-Cilag Pharma GmbH Condition: Crohn's Disease and Colitis
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Crohn's Disease and Colitis Trial, Recruiting

NCT07606339
Recruiting Not Applicable

voxsanity.com.au · Eligibility summary from public government registries · 18 August 2026 · not medical advice

Who may and may not be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who may be able to join

  • A treating doctor must decide that the person is appropriate for biologic treatment and has prescribed guselkumab in line with the officially approved uses for this medicine, and the person must be enrolled in the trial before or on the day of their first dose.
  • The person must have a confirmed diagnosis of moderate-to-severe ulcerative colitis (UC) or Crohn's disease (CD) recorded in their medical records.
  • The person must sign an agreement/consent form that allows the trial team to check their source data, in line with local requirements.

Who may not be able to join

Each point below is a reason the trial team may not be able to accept someone. It is not a list of requirements to meet.

  • The person has a medical reason that makes guselkumab unsuitable for them according to the medicine's official label.
  • The person is currently taking part in another clinical study that involves a medical intervention.
  • The person has previously been treated with a type of medicine called an IL-23 inhibitor, which includes guselkumab (Tremfya), risankizumab (Skyrizi), or mirikizumab (Omvoh) — though people who have previously used ustekinumab may still be considered.
  • The person has already been through more than four different advanced treatments for inflammatory bowel disease, including biologics and/or small molecule medicines.
  • The person is not able to give their own informed consent to participate.

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 23 July 2026
This study is not part of the standard drug-approval phase pathway (for example an observational, device, behavioural, or registry study), so a phase success rate does not apply.

Contact this trial

Principal Investigator: Janssen-Cilag Pharma GmbH Clinical Trial, Janssen-Cilag Pharma GmbH

Phone: 844-434-4210

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Not Applicable
Sponsor
Janssen-Cilag Pharma GmbH
Registry
ClinicalTrials.gov
Start date
15 June 2026
Est. completion
15 June 2029

Primary endpoints

Persistence with Guselkumab Treatment

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 23 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov