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This trial is complete. It is no longer accepting participants. Results may be available on ClinicalTrials.gov.

NCT03926130

NCT03926130
Completed Phase 3 🇦🇺 Australian site

Who may be able to join

Who might be able to join this trial:

  • You have been diagnosed with Crohn's disease for at least 3 months before the start of the trial.
  • Your Crohn's disease has been confirmed as moderate to severe, based on specific medical assessments (confirm with trial site).
  • Previous treatments for your Crohn's disease — either standard medications or biologic therapies — have not worked well enough, stopped working, or caused side effects you could not tolerate.
  • If you are female, you must follow specific birth control requirements set by the trial (confirm with trial site for details).

Who may not be able to join:

  • You have been diagnosed with ulcerative colitis, an unclassified form of inflammatory bowel disease, or short bowel syndrome.
  • You currently have, or are suspected to have, an internal abscess (a pocket of infection inside the body) — though some types of abscesses that have been fully drained and healed a certain number of weeks before the trial may be acceptable (confirm with trial site).
  • You have a stoma, an ileoanal pouch, or an ostomy (any surgically created opening in the abdomen for waste removal).
  • You have had bowel surgery within the last 6 months, or any other surgery inside or outside the abdomen within the last 3 months.
  • You have ever received a specific type of medication that targets a protein called IL-23 (confirm with trial site for a list of these medicines).

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.

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.

Trial details

Status
Completed
Phase
Phase 3
Sponsor
Eli Lilly and Company
Registry
clinicaltrials_gov
Start date
23 July 2019
Est. completion
23 August 2023

Where this trial is recruiting

🇦🇷 Argentina 🇦🇺 Australia 🇦🇹 Austria 🇧🇪 Belgium 🇧🇷 Brazil 🇨🇦 Canada 🇨🇳 China 🇭🇷 Croatia 🇨🇿 Czechia 🇩🇰 Denmark 🇫🇷 France 🇩🇪 Germany 🇭🇺 Hungary 🇮🇳 India 🇮🇱 Israel 🇮🇹 Italy 🇯🇵 Japan 🇱🇻 Latvia 🇱🇹 Lithuania 🇲🇽 Mexico 🇳🇱 Netherlands 🇵🇱 Poland Puerto Rico 🇷🇴 Romania 🇷🇺 Russia 🇷🇸 Serbia 🇸🇰 Slovakia 🇰🇷 South Korea 🇪🇸 Spain 🇨🇭 Switzerland Turkey (Türkiye) 🇺🇦 Ukraine 🇬🇧 United Kingdom 🇺🇸 United States

11 site(s) in Australia. Confirm current status and contact details directly with the trial site.

Primary endpoints

Percentage of Adult Participants Achieving Clinical Response at Week 12 and Endoscopic Response at Week 52 (Placebo and Mirikizumab); Percentage of Adult Participants Achieving Clinical Response at Week 12 and Clinical Remission at Week 52 (Placebo and Mirikizumab)

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: 30 June 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

View original record on ClinicalTrials.gov