Phase 1 Crohn's Disease and Colitis Trial, Recruiting NCT07665723 Sponsor: Hoffmann-La Roche Condition: Crohn's Disease and Colitis
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Phase 1 Crohn's Disease and Colitis Trial, Recruiting

NCT07665723
Recruiting Phase 1

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 weigh at least 40 kilograms (about 88 pounds)
  • People who agree to follow the contraceptive (birth control) requirements set out by the trial
  • People who have a confirmed diagnosis of ulcerative colitis (UC), supported by clinical assessment, camera examination of the bowel, and tissue sample analysis
  • People whose ulcerative colitis is confirmed as active by a camera examination of the bowel, with inflammation extending at least 15 centimetres from the end of the bowel
  • People whose ulcerative colitis is considered moderately to severely active, based on a specific scoring system (called the modified Mayo score) with a result between 5 and 9, including a particular sub-score from the camera examination, as reviewed by a central team

Who may not be able to join:

  • People who have a current diagnosis of Crohn's disease, fistulas (abnormal tunnels in or around the bowel or abdomen), abscesses, indeterminate colitis, unclassified inflammatory bowel disease, microscopic colitis, colitis caused by reduced blood flow, infection, or radiation, or active diverticular disease (small pouches causing problems in the bowel)
  • People who have a stoma (an opening on the abdomen for waste) or a surgically created internal pouch (ileoanal pouch)
  • People who currently have or are suspected of having a condition called primary sclerosing cholangitis (a disease affecting the bile ducts in the liver)
  • People who do not have accessible veins suitable for blood draws or intravenous procedures
  • People who have had a major surgery within 6 weeks before the screening visit, or who have a major surgery planned during the study period
  • People who have had a history of alcohol, drug, or chemical misuse within the past year before screening

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 28 July 2026
Phase 1: approximately ~10% 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: 888-662-6728 (U.S. Only)

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

GP referral letter

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Trial details

Status
Recruiting
Phase
Phase 1
Registry
ClinicalTrials.gov
Start date
29 June 2026
Est. completion
31 July 2027

Where this trial is recruiting

🇩🇪 Germany 🇬🇧 United Kingdom 🇺🇸 United States

Primary endpoints

Area Under the Plasma Concentration-time Curve Up to Time t (AUC0-t [AUC last]) of CYP Probe Substrates (Midazolam, 1-OH-Midazolam, Omeprazole, 5-OH-Omeprazole, Dextromethorphan, Dextrorphan, R-Warfarin, S-Warfarin, Caffeine, and Paraxanthine); Area Under the Plasma Concentration-time Curve Extrapolated to Infinity (AUCinf) of CYP Probe Substrates (Midazolam, 1-OH-Midazolam, Omeprazole, 5-OH-Omeprazole, Dextromethorphan, Dextrorphan, R-Warfarin, S-Warfarin, Caffeine, and Paraxanthine); Maximum Plasma Concentration (Cmax) of CYP Probe Substrates (Midazolam, 1-OH-Midazolam, Omeprazole, 5-OH-Omep...

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: 28 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