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Mirikizumab-

Phase 3

Psoriasis | Monoclonal antibody | Immunology |Eli Lilly and Company|Last Updated: Jul 25, 2024

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
RandomizedDouble-BlindPLACEBO_CONTROLLEDDMCBiomarker
Total Trials3
Total Enrollment2,059
FDA Designations
No designations recorded
Clinical Trials (3)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT03535194A Study to Assess if Mirikizumab is Effective and Safe Compared to Secukinumab and Placebo in Moderate to Severe Plaque Psoriasis (OASIS-2)PHASE3 COMPLETED 1,484Jun 26, 2018Jun 3, 2020Mar 30, 2021178 United States, Argentina +14
NCT03482011A Study to Evaluate the Efficacy and Safety of Mirikizumab (LY3074828) in Participants With Moderate-to-Severe Plaque PsoriasisPHASE3 COMPLETED 530Apr 24, 2018Jan 16, 2020Sep 25, 202069 United States, Germany +7
NCT01947933A Safety Study of Mirikizumab (LY3074828)PHASE1 COMPLETED 45Oct 1, 2013Feb 1, 2015Jul 25, 20242 Canada
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Study Endpoints
Primary Endpoints
Percentage of Participants With a Static Physician's Global Assessment (sPGA) of (0,1) With at Least a 2-point Improvement From Baseline
Week 16

The sPGA is the physician's determination of the participant's psoriasis lesions overall at a given time point. Lesions were categorized by descriptions for induration, erythema, and scaling. Participant's psoriasis was assessed as 0 (clear), 1 (minimal), 2 (mild), 3 (moderate), 4 (severe), or 5 (very severe). An sPGA responder was defined as having a post-baseline sPGA score of "0" or "1" with at least a 2-point improvement from baseline.

Percentage of Participants Achieving a ≥90% Improvement in Psoriasis Area and Severity Index (PASI 90) From Baseline
Week 16

PASI combines the extent of body surface involvement in 4 anatomical regions (head, trunk, arms, and legs) and the severity of scaling, redness, and plaque induration/infiltration (thickness) in each region, yielding an overall score of 0 for no psoriasis (PsO) to 72 for the most severe disease. For each region the percent area of skin involved was estimated from 0 (0%) to 6 (90%-100%) and severity was estimated by clinical signs of erythema, induration and scaling with a scores range from 0 (no involvement) to 4 (severe involvement). Each area is scored separately and the scores then combined for the final PASI. Final PASI calculated as: sum of severity parameters for each region \* area score \* weighing factor \[head (0.1), upper limbs (0.2), trunk (0.3), lower limbs (0.4)\]. Overall scores range from 0 (no PsO) to 72 (the most severe disease).

Percentage of Participants With a Static Physician's Global Assessment of (sPGA) (0,1) With at Least a 2-point Improvement From Baseline
Week 16

The sPGA is the physician's determination of the participant's psoriasis (PsO) lesions overall at a given time point. Lesions were categorized by descriptions for induration, erythema, and scaling. Participant's PsO was assessed as 0 (clear), 1 (minimal), 2 (mild), 3 (moderate), 4 (severe), or 5 (very severe). An sPGA responder was defined as having a post-baseline sPGA score of "0" or "1" with at least a 2-point improvement from baseline.

Percentage of Participants Achieving a ≥90% Improvement From Baseline in Psoriasis Area and Severity Score (PASI 90)
Week 16

PASI combines the extent of body surface involvement in 4 anatomical regions (head, trunk, arms, and legs) and the severity of scaling, redness, and plaque induration/infiltration (thickness) in each region, yielding an overall score of 0 for no psoriasis (PsO) to 72 for the most severe disease. For each region the percent area of skin involved was estimated from 0 (0%) to 6 (90%-100%) and severity was estimated by clinical signs of erythema, induration and scaling with a scores range from 0 (no involvement) to 4 (severe involvement). Each area is scored separately and the scores then combined for the final PASI. Final PASI calculated as: sum of severity parameters for each region \* area score \* weighing factor \[head (0.1), upper limbs (0.2), trunk (0.3), lower limbs (0.4)\]. Overall scores range from 0 (no PsO) to 72 (the most severe disease).

Number of Participants With One or More Adverse Event(s) (AEs) Considered by the Investigator to Be Related to Study Drug Administration
Baseline through Week 12

This outcome has the list of adverse events which are related to the study drug. A summary of AEs, regardless of causality, is located in the Reported Adverse Events module.

Secondary Endpoints
Percentage of Participants Achieving a 75% Improvement in PASI 75
Week 16
Percentage of Participants With ≤1% of Body Surface Area (BSA) With Psoriasis Involvement
Week 16
Percentage of Participants With a Psoriasis Symptoms Scale (PSS) Symptom Score of 0 in Those With PSS Symptom Score of ≥1 at Baseline
Week 16
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
250mg Q4W/250mg Q8W MirikizumabEXPERIMENTALParticipants received 250 Milligrams (mg) Mirikizumab once every four weeks (Q4W) by subcutaneous injection during blinded induction period followed by 250mg Mirikizumab once every eight weeks (Q8W) in maintenance period. Participants received matching placebo to blind Secukinumab.
250mg Q4W/125mg Q8W MirikizumabEXPERIMENTALParticipants received 250mg Mirikizumab once every four weeks (Q4W) by subcutaneous injection during blinded induction period followed by 125mg Mirikizumab once every eight weeks (Q8W) in maintenance period. Participants received matching placebo to blind Secukinumab.
Placebo/250mg MirikizumabEXPERIMENTALParticipants received matching placebo at weeks 0, 1, 2, 3, 4, 8, and 12 by subcutaneous injection during blinded induction period followed by 250mg Mirikizumab Q4W from week 16 to 32 followed by 250mg Mirikizumab Q8W from week 32 to 48 in maintenance period. Participants received matching placebo to blind Secukinumab.
300mg SecukinumabACTIVE_COMPARATORParticipants received 300mg Secukinumab at weeks 0, 1, 2, 3, 4, 8, and 12 by subcutaneous injection during induction period followed by 300mg Secukinumab Q4W from week 16 to 52 in maintenance period.
Japan GPP/EPEXPERIMENTALParticipants received 250mg Mirikizumab Q4W in induction period followed by 250mg Q8W in maintenance period by subcutaneous injection.
MirikizumabEXPERIMENTALInduction Period: Participants received 250 milligrams (mg) mirikizumab administered subcutaneously (SC) every 4 weeks (Q4W). Maintenance Period: Participants received one of the four options below: Placebo administered SC every 8 weeks (Q8W) for responders (≥PASI 90). 125 mg mirikizumab administered SC Q8W for responders (≥PASI 90). 250 mg mirikizumab administered SC Q8W for responders (≥PASI 90). 250 mg mirikizumab administered SC Q8W for non-responders (\<PASI 90).
PlaceboPLACEBO_COMPARATORInduction Period: Participants received placebo administered SC Q4W. Maintenance Period: Participants received one of the two options below: Placebo administered SC Q8W for responders (≥PASI 90). 250 mg mirikizumab administered SC Q4W during week 16 to week 32 and Q8W during week 40 and 48 for non-responders (\< PASI 90).
Placebo IVPLACEBO_COMPARATORParticipants with psoriasis will receive a single dose of placebo matching mirikizumab intravenously (IV)
Mirikizumab IVEXPERIMENTALParticipants with psoriasis will receive a single escalating dose of 5 milligram (mg), 20 mg, 60 mg, 120 mg, 200 mg, 350 mg, or 600 mg mirikizumab, IV
Mirikizumab SCEXPERIMENTALHealthy participants will receive a single dose of 120 mg mirikizumab subcutaneously (SC).
Interventions
NameTypeDescription
MirikizumabDRUGAdministered SC
PlaceboDRUGAdministered SC
SecukinumabDRUGAdministered SC
Mirikizumab- IVBIOLOGICALAdministered IV
Mirikizumab - SCBIOLOGICALAdministered SC
Placebo - IVBIOLOGICALAdministered IV
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites178

Inclusion Criteria: * Participant must have chronic plaque psoriasis for at least 6 months. Exclusion Criteria: * Participant must not be breastfeeding or nursing woman. * Participant must not have had serious, opportunistic, or chronic/recurring infection within 3 months. * Participant must not ...

Countries:United StatesArgentinaAustraliaCanadaCzechiaFranceGermanyHungaryIsraelItalyJapanPolandPuerto RicoSouth KoreaSpainUnited KingdomMexicoRussiaTaiwan
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