Crohn's Disease and Colitis Trial, Recruiting NCT06512597 Sponsor: Icahn School of Medicine at Mount Sinai Condition: Crohn's Disease and Colitis
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Crohn's Disease and Colitis Trial, Recruiting

NCT06512597
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:

  • You are between 18 and 65 years old, of any sex, gender, or racial/ethnic background
  • You have been diagnosed with Crohn's disease (CD), confirmed by both a camera examination of the gut (endoscopy) and a tissue sample (biopsy)
  • You are currently experiencing active Crohn's disease symptoms, based on a standard symptom scoring system called the CDAI (confirm with trial site for exact score details)
  • You have signs of active inflammation in your gut, shown by a recent camera examination, an imaging scan, or raised levels of certain markers in your blood or stool
  • You are planning to start, or have recently started (within the past 2 weeks or in the next 6 weeks), one of a specific group of Crohn's medications — either an anti-TNF drug (adalimumab, certolizumab, or infliximab) or an anti-IL-23 drug (risankizumab, guselkumab, or mirikizumab)
  • You live in one of the 30+ US states covered by a special psychology practice licence held by the trial doctor (confirm with trial site which states are included)

Who may not be able to join:

  • Your Crohn's disease does not show active inflammation on a gut camera examination at the start of the trial
  • You are not able to give your own informed consent to take part
  • You are currently pregnant or planning to become pregnant in the next 12 months
  • You are experiencing severe mental health or psychiatric symptoms
  • You have previously had surgery related to your Crohn's disease

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

Principal Investigator: Laurie Keefer, PhD, Icahn School of Medicine at Mount Sinai

Phone: 212-824-7770

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
1 November 2024
Est. completion
30 July 2027

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

The PROMIS Global Health Scale

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