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Mirikizumab -

Phase 2

Colitis, Ulcerative | Small molecule | Immunology |Eli Lilly and Company|Last Updated: Jun 4, 2026

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedACTIVE_CONTROLLEDBiomarker
Total Trials1
Total Enrollment60
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT07483073A Master Protocol (IIBD): A Study of Multiple Drugs in Adults With Ulcerative Colitis or Crohn's DiseasePHASE2 RECRUITING 60May 4, 2026Mar 1, 2028Jun 4, 202672 United States, Belgium +8
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Study Endpoints
Primary Endpoints
Number of Participants Allocated to Each of the Intervention-Specific Appendices (ISA)
Baseline, Up to Day 42
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
MirikizumabACTIVE_COMPARATORStudy Period 1: mirikizumab administered via IV. Study Period 2: Responders will receive mirikizumab SC.
LY4395089 and Mirikizumab Co-AdministrationEXPERIMENTALStudy Period 1: Co-administration of LY4395089 administered orally and mirikizumab administered IV. Study Period 2: Responders will stop LY4395089 and receive mirikizumab SC.
Interventions
NameTypeDescription
Mirikizumab - Intravenous (IV)DRUGAdministered IV
Mirikizumab - Subcutaneous (SC)DRUGAdministered SC
LY4395089DRUGAdministered orally
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Eligibility Criteria
Age Range18 Years — 80 Years
SexALL
Healthy VolunteersNo
Study Sites72

Inclusion Criteria: * Must have an established diagnosis of Ulcerative Colitis (UC) or Crohn's Disease (CD) for at least 3 month duration, which includes clinical and endoscopic evidence of UC or CD and a histopathology report that supports a diagnosis of UC or CD. * For UC: * Have moderately to...

Countries:United StatesBelgiumBrazilCanadaChinaGermanyHungaryIsraelItalyPoland
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Recent Changes (Last 90 Days)
LOWJun 4, 2026NCT07483073lastUpdatePostDate: changed
LOWJun 4, 2026NCT07483073lastUpdatePostDate: changed
LOWJun 4, 2026NCT07483073lastUpdatePostDate: changed
LOWJun 4, 2026NCT07483073lastUpdatePostDate: changed
LOWMay 26, 2026NCT07483073Status: NOT_YET_RECRUITING → RECRUITING
LOWMay 24, 2026NCT07483073studyFirstPostDate: changed