A Phase 3 interventional study of Mirikizumab and Mirikizumab in Ulcerative Colitis, Ulcerative Colitis Chronic and Inflammatory Bowel Diseases, sponsored by Eli Lilly and Company. Recruiting at 69 sites in 16 countries. Open to participants aged 2 Years to 19 Years. Per ClinicalTrials.gov, last updated 2026-10-07.
Sponsored by Eli Lilly and Company · Phase 3, Interventional, and Treatment
Among 13 studies testing mirikizumab in Colitis, Ulcerative — 4 open to participants now, 5 under way, 2 of them phase 3. mirikizumab · Colitis, Ulcerative.
Among the 13 studies testing mirikizumab in Colitis, Ulcerative, this one is the 8th largest by planned enrollment, is one of 2 that started in 2021, is one of 7 in phase 3, and was the 7th registered.
1,853 studies on the registry are indexed under Colitis, Ulcerative; 472 are open to participants now.
Browse Colitis, Ulcerative studies →4 of the 13 studies testing mirikizumab in Colitis, Ulcerative are open now, in 12 countries. Recruiting first, the newest first:
University Hospital Schleswig-Holstein · Sites in Germany
Specialty Networks Research. · Sites in United States
Rubix LS · Sites in United States
By country, each count listing its studies:
mirikizumab: first FDA approval 2023 (OMVOH), first EMA approval 2023. What it is approved for, and how studies give it, is on its page →
Of the 305 Colitis, Ulcerative studies recruiting now, 134 (44%) set no upper age limit and 134 (44%) stop at 75 or younger; 71 take children under 18; 40 take healthy volunteers.
This study: 2 Years to 19 Years · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
13 studies; the count open now beside each. This study's row is marked.
First in 2015; this study’s year is marked. 2 started in 2021.
This study's planned enrollment of 150 is above the median of 70 across 1,236 interventional studies indexed under Colitis, Ulcerative.
Median enrollment 172 across the 13 interventional studies. Of the 7 that completed or were terminated, 5 (71%) have results posted.
This tab as a report to print or save as PDF → With an account.
10 of 13 have an industry lead sponsor. The 5 most frequent:
Eli Lilly and Company is the lead sponsor of 2,106 studies on the registry; 152 are open to participants now.
Of its 536 completed or terminated interventional studies of FDA-regulated products, 357 (67%) have results posted.
14 studies in Colitis, Ulcerative by Eli Lilly and Company: 5 open now, 7 under way, 3 of them phase 3. Of 6 finished, 5 (83%) have results posted.
Among the 14 studies in Colitis, Ulcerative by Eli Lilly and Company, this one is the 9th largest by planned enrollment, is one of 2 that started in 2021, is one of 8 in phase 3, and was the 7th registered.
Eli Lilly and Company’s Colitis, Ulcerative studies by the year they started, since 2015.
None of the studies under way reaches primary completion within a year.
Among the 13 studies testing mirikizumab in Colitis, Ulcerative, from their registry updates:
Nothing recorded among them since 2026-09-25.
Among Eli Lilly and Company’s 14 in Colitis, Ulcerative:
This tab as a report to print or save as PDF → With an account.
The main purpose of this study is to evaluate the long-term efficacy of mirikizumab in pediatric participants with ulcerative colitis (UC) or Crohn's disease (CD). The study will last about 172 weeks and may include up to 44 visits. Additional treatment may be available to participants via a Continued Access Period.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Dose 1 of Mirikizumab is administered subcutaneously (SC) Dosing is based on the participant's weight.
Drug: Mirikizumab
Dose 2 of Mirikizumab is administered SC Dosing is based on the participant's weight.
Drug: Mirikizumab
Dose 3 of Mirikizumab is administered SC Dosing is based on the participant's weight.
Drug: Mirikizumab
Dose 4 of Mirikizumab is administered SC Dosing is based on the participant's weight.
Drug: Mirikizumab
Dose 5 of Mirikizumab is administered SC Dosing is based on the participant's weight.
Drug: Mirikizumab
Dose 6 of Mirikizumab is administered SC Dosing is based on the participant's weight.
Drug: Mirikizumab
Intravenous (IV) rescue dosing, if response is lost.
Drug: Mirikizumab
Administered SC
Also known as: LY3074828
Administered IV
Also known as: LY3074828
Percentage of Participants with UC in Modified Mayo Score (MMS) Clinical Remission
Clinical Remission based on the MMS
Time frame: Week 52
Percentage of Participants with CD in Pediatric Crohn's Disease Activity Index (PCDAI) Clinical Remission
Clinical Remission based on the PCDAI
Time frame: Week 52
Percentage of Participants with UC in MMS Clinical Response
Clinical Response based on the MMS
Time frame: Week 52
Percentage of Participants with CD in PCDAI Clinical Response
Clinical Response based on the PCDAI
Time frame: Week 52
Percentage of Participants with UC in Pediatric Ulcerative Colitis Activity Index (PUCAI) Clinical Response
Clinical Response based on the PUCAI
Time frame: Week 52
Percentage of Participants with UC in PUCAI Clinical Remission
Clinical Response based on the PUCAI
Time frame: Week 52
Percentage of Participants with UC in Endoscopic Remission
Endoscopic Remission based on the Endoscopic Subscore (ES)
Time frame: Week 52
Percentage of Participants with CD in Endoscopic Remission
Endoscopic Remission in Participants based on the Simple Endoscopic Score for Crohn's Disease (SES-CD)
Time frame: Week 52
Percentage of Participants with UC in Endoscopic Response
Endoscopic Response in Participants based on the ES
Time frame: Week 52
Percentage of Participants with CD in Endoscopic Response
Endoscopic Response based on the SES-CD
Time frame: Week 52
Percentage of Participants with UC in having Endoscopic Subscore = 0
Endoscopic Remission when ES = 0
Time frame: Week 52
Percentage of Participants with UC Histologic-Endoscopic Mucosal Remission
Histologic remission based on histology scoring and endoscopic remission based on endoscopy score
Time frame: Week 52
Percentage of Participants with CD Achieving Histologic Remission
Histologic remission based on histology scoring
Time frame: Week 52
Percentage of Participants with UC in Corticosteroid-free Remission Without Surgery
Corticosteroid-free Remission based on MMS in participants who did not have an ulcerative colitis (UC)-related surgery
Time frame: Week 52
Percentage of Participants with CD in Corticosteroid-free Remission Without Surgery
Corticosteroid-free Remission based on PCDAI in participants who did not have Crohn's disease (CD-related surgery)
Time frame: Week 52
Time to First Dose of Corticosteroid Among Participants with UC Entering Study AMAZ Not on Corticosteroids
Time frame: Week 0 to Week 52
Percentage of Participants Who Achieve both Clinical Remission by PCDAI and Endoscopic Response
Time frame: Week 52
Change from Baseline Over Time in C-reactive Protein, High Sensitivity (hsCRP)
Time frame: Baseline, Week 0 to Week 52
Plan to share: Yes — Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.
Supporting information: Study protocol, Statistical analysis plan, Clinical study report
Time frame: Data are available 6 months after the primary publication and approval of the indication studied in the US and European Union (EU), whichever is later. Data will be indefinitely available for requesting.
Access criteria: A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
Data sharing details ↗ · vivli.org
Started May 2021 (actual). Primary completion is estimated for Dec 2030, 115 months after the start.
Of 87 industry-sponsored phase 3 interventional studies under Colitis, Ulcerative, half reached primary completion within 47 months of starting (the median), counting those still running; a quarter within 31 and three quarters within 70. This study's planned 115 months is above that.
Counting every sponsor, half of 101 studies reached it within 48 months; a quarter within 31 and three quarters within 75.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
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Studies of the drug tested here: Mirikizumab