Trial results
AI generated results 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
According to the results reported on ClinicalTrials.gov, this trial enrolled 1,158 participants in total — 212 in the placebo group (a dummy treatment with no active ingredient), 631 receiving mirikizumab, 309 receiving ustekinumab (a different medicine used for comparison), and 6 adolescents receiving mirikizumab. Most participants completed the study: 159 in the placebo group, 561 in the mirikizumab group, 271 in the ustekinumab group, and 4 in the adolescent group. The trial was measuring two main things in adults with Crohn's disease: first, whether participants showed an early symptom response by week 12 (fewer loose stools and/or less abdominal pain) and then went on to show reduced inflammation visible on camera examination of the bowel (endoscopic response) by week 52; and second, whether those same early responders went on to reach full remission — meaning their overall disease activity score fell below a set threshold — by week 52. The reported data shows that, for the two primary goals measured in adults comparing mirikizumab to placebo: 38.0% of mirikizumab participants met the combined early-response-then-endoscopic-response target, compared with 9.0% in the placebo group. For the combined early-response-then-remission target, 45.4% of mirikizumab participants reached that point by week 52, compared with 19.6% in the placebo group. For the secondary measures, the reported data shows that at week 12, endoscopic response was recorded in 32.5% of mirikizumab participants versus 12.6% for placebo, and clinical remission at week 12 was reported in 37.7% versus 25.1% respectively. By week 52, endoscopic response was reported in 48.4% of mirikizumab participants, 46.3% of ustekinumab participants, and 9.0% of placebo participants. Full remission at week 52 was reported in 54.1% of mirikizumab participants, 48.4% of ustekinumab participants, and 19.6% of placebo participants. No outcome data for the small adolescent group was included in the reported results. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View full results on ClinicalTrials.gov ↗ · Read the linked publication on PubMed (PMID 42309525) ↗
These are the results as reported to ClinicalTrials.gov, not medical advice. Verify independently with the trial site and discuss what they mean for you with your doctor.
Phase 3 Crohn's Disease and Colitis Trial, Completed
voxsanity.com.au · Eligibility summary from public government registries · 18 August 2026 · not medical advice
Who may and may not 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 may be able to join
- 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
Each point below is a reason the trial team may not be able to accept someone. It is not a list of requirements to meet.
- 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.
Trial contact details on record
Principal Investigator: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM -5 PM Eastern time (UTC/GMT - 5 hours, EST), Eli Lilly and Company
Australian sites
This trial is not accepting new participants. These are the contact details ClinicalTrials.gov holds for it, kept here for reference. They are not an invitation to enrol, and the sites listed may no longer be running this trial.
GP referral letter
Print a one-page summary to share with your doctor.
Trial details
Where this trial was run
These are the locations recorded on the registry, including 11 in Australia. They are a historical record: this trial is not enrolling, so they are not places you can join it.
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)
Other options
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.