Crohn's Disease and Colitis Trial, Recruiting NCT07541261 Sponsor: Janssen Research & Development, LLC Condition: Crohn's Disease and Colitis
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Crohn's Disease and Colitis Trial, Recruiting

NCT07541261
Recruiting Not Applicable

Who may 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 might be able to join this trial:

  • People who have been diagnosed with moderate-to-severe Crohn's disease or ulcerative colitis, with that diagnosis recorded in their medical records
  • People whose treating doctor has decided to prescribe them a medication called guselkumab, in line with its officially approved uses in Saudi Arabia, and who are considered suitable for biologic (specialist injectable) treatment
  • People who are enrolled before or on the same day as their first dose of guselkumab (but only after the doctor has already made the treatment decision)
  • People who are willing and able to sign a consent form allowing the trial team to verify their medical information

Who may not be able to join:

  • People for whom guselkumab is medically unsuitable or contraindicated based on the official prescribing guidelines
  • People who are currently taking part in another interventional clinical trial
  • People who have previously been treated with a class of medications called IL-23 inhibitors — this includes guselkumab (Tremfya), risankizumab (Skyrizi), or mirikizumab (Omvoh) — although prior use of a related medication called ustekinumab may be an exception (confirm with trial site)
  • People who have already tried more than four different advanced IBD treatments, such as biologics or small molecule medications
  • People who are unable to provide informed consent

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 26 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

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
Registry
ClinicalTrials.gov
Start date
12 May 2026
Est. completion
2 January 2029

Where this trial is recruiting

🇸🇦 Saudi Arabia

Primary endpoints

Time to Guselkumab Discontinuation

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: 26 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