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VIB1116

Phase 1

Dendritic Cell -Mediated Rheumatic Diseases | Small molecule | Other |Amgen Inc.|Last Updated: Dec 13, 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_CONTROLLEDBiomarker
Total Trials1
Total Enrollment73
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT04948099A Study of Single and Multiple Ascending Doses of VIB1116 in Rheumatic DiseasesPHASE1 COMPLETED 73Jul 6, 2021Jul 3, 2023Dec 13, 202411 United States, Poland
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Study Endpoints
Primary Endpoints
Treatment-emergent adverse events, treatment-emergent serious adverse events, and adverse events of special interest
Up to Day 141
Secondary Endpoints
Serum concentration of VIB1116 and noncompartmental PK parameters
Up to Day 141
Change from baseline in the blood levels of plasmacytoid dendritic cells
Up to Day 141
Percentage of Participants who are ADA (antidrug antibody) positive
Up to Day 141
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Study Design & Arms
AllocationRANDOMIZED
MaskingTRIPLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
VIB1116EXPERIMENTALSingle dose of VIB1116, SC or IV administration. Multiple doses of VIB1116, SC administration.
PlaceboPLACEBO_COMPARATORSingle dose of Placebo, SC or IV administration. Multiple doses of Placebo, SC administration.
Interventions
NameTypeDescription
VIB1116DRUGVIB1116
PlaceboDRUGPlacebo
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Eligibility Criteria
Age Range18 Years — 65 Years
SexALL
Healthy VolunteersNo
Study Sites11

Inclusion Criteria: * Male or female ≥ 18 years of age and ≤ 60 years of age and a body mass index (BMI) \< 30 kg/m² or, in patients who have completed dosing with a vaccine against COVID-19 and are at least 1 month post the last dose, ≤ 65 years of age and BMI \< 35 kg/m\^2 * A diagnosis of one of...

Countries:United StatesPoland
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