Phase 2 Crohn's Disease and Colitis Trial, Recruiting NCT07415044 Sponsor: Eli Lilly and Company Condition: Crohn's Disease and Colitis
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Phase 2 Crohn's Disease and Colitis Trial, Recruiting

NCT07415044
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 been diagnosed with ulcerative colitis (UC) for at least 3 months before joining, confirmed by a camera examination of the bowel (endoscopy)
  • Your UC is considered moderately to severely active, based on specific scoring systems that measure symptoms like rectal bleeding (confirm with trial site)
  • Your UC affects areas of the bowel beyond just the rectum (i.e., it extends further up into the colon)
  • If you have had UC symptoms for more than 8 years, you have had a bowel cancer screening (colonoscopy) within the past year, or as recommended by local guidelines
  • You have tried at least one standard treatment (such as steroids) or one advanced treatment (such as a biologic medicine), but it either did not work well enough, stopped working, or caused side effects you could not tolerate
  • You are able and willing to follow the contraception requirements set out by the trial

Who may not be able to join:

  • You have been diagnosed with Crohn's disease, unclassified inflammatory bowel disease, or a liver condition called primary sclerosing cholangitis
  • You have an inherited condition that affects your immune system, or a known genetic cause of bowel inflammation similar to UC
  • You have already had surgery to remove part of your bowel, or are expected to need such surgery
  • You have serious bowel complications such as toxic megacolon, an abscess inside the abdomen, or a significant narrowing of the bowel
  • You have current or past evidence of cancer in the digestive tract, or certain abnormal tissue changes that could increase the risk of digestive cancer
  • You have been diagnosed with any cancer in the last 5 years
  • You have previously tried a medication called vedolizumab and it did not work adequately for you

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 22 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

Principal Investigator: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 8 AM - 8 PM Eastern time (UTC/GMT - 5 hours, EST), Eli Lilly and Company

Phone: 1-317-615-4559

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
26 March 2026
Est. completion
1 June 2030

Where this trial is recruiting

🇦🇷 Argentina 🇧🇷 Brazil 🇨🇦 Canada 🇨🇳 China 🇨🇴 Colombia 🇭🇷 Croatia 🇨🇿 Czechia 🇫🇷 France 🇬🇷 Greece 🇭🇺 Hungary 🇮🇳 India 🇮🇱 Israel 🇮🇹 Italy 🇯🇵 Japan 🇱🇻 Latvia 🇱🇹 Lithuania 🇲🇽 Mexico 🇵🇱 Poland 🇵🇹 Portugal Puerto Rico 🇷🇸 Serbia 🇸🇰 Slovakia 🇿🇦 South Africa 🇰🇷 South Korea 🇹🇼 Taiwan Turkey (Türkiye) 🇺🇦 Ukraine 🇺🇸 United States

Primary endpoints

Percentage of Participants Who Achieve Clinical Remission with Modified Mayo Score (mMS); Percentage of Participants Who Achieve Clinical Remission with mMS Among Participants Who Achieved Clinical Response with LY4268989 at Week 10

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: 22 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