Phase 2 Crohn's Disease and Colitis Trial, Recruiting NCT06420492 Sponsor: Brigham and Women's Hospital Condition: Crohn's Disease and Colitis
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Phase 2 Crohn's Disease and Colitis Trial, Recruiting

NCT06420492
Recruiting Phase 2

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 have ulcerative colitis (UC) and are currently experiencing a severe flare, either at home or in hospital
  • You are able to understand and agree to participate in the study yourself
  • You have had a confirmed diagnosis of UC for more than 3 months
  • A colonoscopy has shown that at least 15 cm of your colon is affected by UC
  • You have a liver condition called primary sclerosing cholangitis (PSC) — this does not stop you from joining
  • You have tried oral prednisone at a dose of 30 mg or more for at least 5 days, but your symptoms are still significantly active (confirm with trial site)
  • You are taking 20 mg or less of oral prednisone daily and plan to keep the same dose throughout the study
  • You are taking an anti-TNF medication (such as a biologic injection or infusion) and have been on a steady dose for at least 10 weeks, with no plans to change it
  • You are taking Rinvoq (Upadacitinib) and have been on a steady dose for at least 4 weeks, with no plans to change it
  • You are taking Xeljanz (Tofacitinib) and have been on a steady dose for at least 4 weeks, with no plans to change it
  • You are taking another biologic medication for UC and have been on a steady dose for at least 10 weeks, with no plans to change it

Who may not be able to join:

  • You have high blood pressure that is not well controlled (confirm with trial site)
  • You have chronic kidney disease with reduced kidney function (confirm with trial site)
  • You have liver problems shown in blood tests, unless they are caused by PSC
  • You currently have a bowel infection called C. difficile, or have not had a negative test for it within the last month
  • You have a bowel infection or colitis caused by an infection or a medication
  • You have been diagnosed with Crohn's disease or a type of colitis that is unclear/unconfirmed
  • You have severe liver disease
  • You are pregnant or breastfeeding
  • You have been diagnosed with cancer within the last 5 years
  • You have an immune system condition that you were born with or developed
  • You have diabetes or lupus
  • You have taken part in another clinical trial in the last 30 days, or are currently in another trial
  • You have a history of, or are at risk for, heart conditions such as irregular heartbeat, a heart rhythm disorder, heart failure, stroke, or coronary artery disease
  • You stopped taking Rinvoq (Upadacitinib) or Xeljanz (Tofacitinib) less than 4 weeks ago
  • You stopped taking any other UC medication less than 8 weeks ago

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
Phase 2: approximately ~30% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.
Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.

Contact this trial

Phone: 617 732-6389

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 2
Registry
ClinicalTrials.gov
Start date
30 September 2025
Est. completion
1 December 2026

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Sulfur Metabolism

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