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VIB1116

Phase 1

Dendritic Cell -Mediated Rheumatic Diseases | Small molecule | Immunology |Amgen Inc.|Last Updated: Dec 13, 2024

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment73

FDA Designations

No designations recorded

Clinical trial landscape

VIB1116 · 1 trial · 1 indication

Phase 1 1
NCT04948099A Study of Single and Multiple Ascending Doses of VIB1116 in Rheumatic DiseasesDendritic Cell -Mediated Rheumatic Diseases
COMPLETED73 Analytics
PHASE1COMPLETED
A Study of Single and Multiple Ascending Doses of VIB1116 in Rheumatic Diseases
Dendritic Cell -Mediated Rheumatic DiseasesUnlock trial analytics

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 to 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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Frequently asked questions about VIB1116

What is VIB1116 used for?

VIB1116 is an investigational small molecule being developed for the treatment of dendritic cell-mediated rheumatic diseases. It is currently in Phase 1 clinical development and has not been approved by regulatory authorities. The drug is being studied in patients with these autoimmune and inflammatory conditions.

Who makes VIB1116?

VIB1116 is being developed by Amgen Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol AMGN. Amgen is conducting clinical trials to evaluate the safety and efficacy of VIB1116 in patients with dendritic cell-mediated rheumatic diseases.

What phase is VIB1116 in?

VIB1116 is in Phase 1 clinical development. A Phase 1 study of the drug has been completed, involving 73 participants. The drug remains investigational and is not yet approved for commercial use. Further clinical trials would be needed to establish its safety and efficacy.

What clinical trials is VIB1116 in?

VIB1116 has one completed Phase 1 clinical trial registered as NCT04948099, titled 'A Study of Single and Multiple Ascending Doses of VIB1116 in Rheumatic Diseases.' This randomized, double-blind, placebo-controlled study enrolled 73 participants in the United States and Poland.

How does VIB1116 work?

VIB1116 is a small molecule designed to target dendritic cell-mediated pathways involved in rheumatic diseases. By modulating the activity of dendritic cells, which play a key role in immune responses, the drug aims to address the underlying inflammatory processes in these conditions.