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Izokibep

Phase 2

Uveitis | Small molecule | Ophthalmology |ACELYRIN, INC.|Last Updated: Feb 12, 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
UNCONTROLLEDBiomarker
Total Trials1
Total Enrollment7
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT04706741A Trial of the Efficacy and Safety of Izokibep in the Treatment of Non-anterior UveitisPHASE2 COMPLETED 7Jan 6, 2022Nov 14, 2022Feb 12, 20244 United States
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Study Endpoints
Primary Endpoints
Complete Response
BL to Week 10

Complete Response is defined as Yes/No by visit by meeting at least 1 of the following criteria in at least one eye: 1. Inflammatory, chorioretinal and/or inflammatory retinal vascular lesions - No such active lesions; all prior lesions appear inactive 2. ACC Count - Trace or absent (0.5+ or 0) 3. Vitreous Haze - Trace or absent (0.5+ or 0)

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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Izokibep and maintenance corticosteroid doseEXPERIMENTALIzokibep+ Prednisolon/Prednisone
Interventions
NameTypeDescription
IzokibepDRUGIzokibep is an Interleukin-17 Inhibitor that will be administered subcutaneously
Prednisone/PrednisoloneDRUGBackground Corticosteroid
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites4

Inclusion Criteria: 1. ≥18 years of age at SCR 2. Previously documented medical history with diagnosed unilateral or bilateral NIIPPU 3. Active disease at BL defined by the presence of at least 1 of the following criteria in at least one eye despite treatment with stable doses of corticosteroids fo...

Countries:United States
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