Phase 4 Crohn's Disease and Colitis Trial, Recruiting NCT07616687 Sponsor: Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives Condition: Crohn's Disease and Colitis
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Phase 4 Crohn's Disease and Colitis Trial, Recruiting

NCT07616687
Recruiting Phase 4

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 Crohn's disease according to recognised European guidelines (ECCO guidelines)
  • People who are 18 years of age or older at the time of signing consent to participate
  • People who have no medical reasons that would prevent them from taking the study medication, guselkumab
  • People whose Crohn's disease is currently active, shown by reported symptoms such as abdominal pain or frequent bowel movements, and a stool test result showing inflammation above a certain level (faecal calprotectin above 250 ug/g)
  • People who have had active disease confirmed within the past 2 months through a camera examination of the bowel, an MRI scan, or an intestinal ultrasound
  • People who are not currently taking part in any other interventional research study
  • People who have either never received an advanced Crohn's disease therapy before, or who have previously received one or more advanced therapies, provided this aligns with the approved use of guselkumab for Crohn's disease
  • Women who could potentially become pregnant must have a negative blood pregnancy test at the first study visit

Who may not be able to join:

  • People who are under a legal protection order or guardianship arrangement
  • People who have previously been treated with a medication that targets a substance called IL-23
  • People who are currently using another advanced therapy at the same time as guselkumab
  • People who have a stoma (an opening on the abdomen used to redirect the bowel)
  • People who are currently pregnant or breastfeeding
  • People whose Crohn's disease mainly affects the area around the back passage (perianal disease)
  • People who have a currently active and significant infection, or who have HIV, Hepatitis B, Hepatitis C, or active tuberculosis

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 9 July 2026
Phase 4 trials study a drug that has already been approved, monitoring long-term safety and effectiveness in real-world use.

Contact this trial

Principal Investigator: Mathurin Fumery, Investigator, Hospital of Amiens, France

Phone: 0033 6 85 29 97 64

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
Phase 4
Sponsor
Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives
Registry
ClinicalTrials.gov
Start date
18 June 2026
Est. completion
15 March 2029

Where this trial is recruiting

🇫🇷 France

Primary endpoints

- Steroid free clinical remission (SFCR) associated with fecal calprotectin < 250 ug/g at Week 48; - Steroid free clinical remission (SFCR) associated with fecal calprotectin < 250 ug/g at Week 48

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: 9 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