Phase 3 Crohn's Disease and Colitis Trial, Recruiting NCT04844606 Sponsor: Eli Lilly and Company Condition: Crohn's Disease and Colitis
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Phase 3 Crohn's Disease and Colitis Trial, Recruiting

NCT04844606
Recruiting Phase 3

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 were previously enrolled in one of four specific related studies (NCT05784246, NCT04004611, NCT03926130, or NCT05509777) and whose doctor believes they would benefit from continuing treatment with mirikizumab
  • People from those previous studies who completed all required visits and assessments at the end of that study while still taking the study medication
  • Female participants who agree to use contraception as required by the trial

Who may not be able to join:

  • People who experienced a serious harmful reaction or medical event during their previous study, or who developed another condition, that would make continuing mirikizumab too risky
  • People who had to permanently or temporarily stop taking the study medication during their previous study in a way that would make restarting mirikizumab unsafe
  • People who have an unstable or poorly controlled illness that could affect their safety during the trial
  • People whose participation in the trial could, for any reason, put their safety at risk or make the study results harder to interpret
  • People who have non-cancerous growths (polyps) in the bowel that have not yet been removed
  • People who are pregnant or breastfeeding

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 3: approximately ~65% 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 3
Registry
ClinicalTrials.gov
Start date
26 May 2021
Est. completion
1 December 2030

Where this trial is recruiting

🇦🇹 Austria 🇧🇪 Belgium 🇧🇷 Brazil 🇨🇦 Canada 🇩🇪 Germany 🇮🇱 Israel 🇮🇹 Italy 🇯🇵 Japan 🇳🇱 Netherlands 🇳🇴 Norway 🇵🇱 Poland 🇵🇹 Portugal 🇰🇷 South Korea 🇪🇸 Spain 🇬🇧 United Kingdom 🇺🇸 United States

Primary endpoints

Percentage of Participants with UC in Modified Mayo Score (MMS) Clinical Remission; Percentage of Participants with CD in Pediatric Crohn's Disease Activity Index (PCDAI) Clinical Remission

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