A Phase 2 interventional study of Mirikizumab - Intravenous (IV) and Mirikizumab - Subcutaneous (SC) in Colitis, Ulcerative and Crohn Disease, sponsored by Eli Lilly and Company. Recruiting at 71 sites in 10 countries. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-11-04.
Sponsored by Eli Lilly and Company · Phase 2, Interventional, and Treatment
Study IIBD is a master protocol that will support a collection of individual sub studies that share key design components. Participants will be assigned to the appropriate study prior to randomization to a treatment group. The studies aim to evaluate the efficacy and safety of new treatments in adults with moderately to severely active ulcerative colitis or Crohn's disease and will last at least 62 weeks.
1,853 studies on the registry are indexed under Colitis, Ulcerative; 472 are open to participants now.
This study's planned enrollment of 60 is below the median of 70 across 1,236 interventional studies indexed under Colitis, Ulcerative.
Browse Colitis, Ulcerative studies →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.
Counted across the registry records on this site, refreshed daily.
The criteria were revised on the registry on Oct 22, 2026. See what changed
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.
For UC:
For CD:
Exclusion Criteria:
Must not have a current diagnosis of inflammatory bowel disease (IBD)-unclassified or primary sclerosing cholangitis
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.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Study Period 1: mirikizumab administered via IV. Study Period 2: Responders will receive mirikizumab SC.
Drug: Mirikizumab - Intravenous (IV) · Drug: Mirikizumab - Subcutaneous (SC)
Study Period 1: Co-administration of LY4395089 administered orally and mirikizumab administered IV. Study Period 2: Responders will stop LY4395089 and receive mirikizumab SC.
Drug: Mirikizumab - Intravenous (IV) · Drug: Mirikizumab - Subcutaneous (SC) · Drug: LY4395089
Administered IV
Also known as: LY3074828
Administered SC
Also known as: LY3074828
Administered orally
Number of Participants Allocated to Each of the Intervention-Specific Appendices (ISA)
Time frame: Baseline, Up to Day 42
Not enrolling at this site — choose another above.
Not enrolling at this site — choose another above.
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 or approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.
Access criteria: A research proposal should be approved by an independent review panel and researchers should sign a data sharing agreement.
Data sharing details ↗ · vivli.org
No publications or documents are linked to this record.
Started May 2026 (actual). Primary completion is estimated for Jun 2027, 13 months after the start.
Of 109 industry-sponsored phase 2 interventional studies under Colitis, Ulcerative, half reached primary completion within 27 months of starting (the median), counting those still running; a quarter within 21 and three quarters within 35. This study's planned 13 months is below that.
Counting every sponsor, half of 153 studies reached it within 28 months; a quarter within 22 and three quarters within 43.
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.
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Studies of the drug tested here: LY4395089