Recent Updates
Recently added Catalysts

VIB4920

Phase 2

Rheumatoid Arthritis | Small molecule | Immunology |Amgen Inc.|Last Updated: Dec 17, 2024

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
Premium
Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
Premium
Trial Design
RandomizedDouble-BlindPLACEBO_CONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment78
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT04163991A Study to Evaluate the Safety and Efficacy of VIB4920 in Participants With Rheumatoid ArthritisPHASE2 COMPLETED 78Dec 9, 2019Dec 28, 2021Dec 17, 202425 United States, Poland
Unlock Drug Trial Details
Study Endpoints
Primary Endpoints
Change From Baseline to Day 113 in DAS28-CRP
Day 1 (Baseline), Day 113

The DAS28-CRP is a composite index used to assess rheumatoid arthritis disease activity, calculated based on the tender joint count (out of 28 evaluated joints), swollen joint count (out of 28 evaluated joints), Patient's Global Assessment of Disease Activity (0-100 mm), and high-sensitivity C-reactive protein (hsCRP; in mg/L). Scores on the DAS28-CRP range from 0 to approximately 10, where higher scores indicate more disease activity. A negative change from baseline indicates improvement in disease activity. Results are from a mixed-effect model for repeated measures (MMRM) analysis with treatment, visit, visit by treatment interaction, and baseline DAS28-CRP score included in the model.

Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Treatment-Emergent Serious Adverse Events (TESAEs), and Treatment-emergent Adverse Events of Special Interest (TEAESIs)
From first dose of study drug through Day 309 ± 7 days

Adverse event (AE): any untoward medical occurrence associated with the use of an intervention in humans, whether or not it is considered intervention-related. Serious adverse event (SAE): an AE that results in any of the following outcomes: death; life-threatening AE; inpatient hospitalization or prolongation of existing hospitalization; persistent or significant incapacity; congenital anomaly/birth defect; other important medical event jeopardizing the participant's well-being. AEs of special interest (AESIs) include: thrombotic and embolic events; anaphylaxis and clinically significant (Common Terminology Criteria for Adverse Events \[CTCAE\] Grade 3 or higher) hypersensitivity reactions; severe infusion-related reactions (CTCAE Grade 3 or higher); immune complex disease; severe (CTCAE Grade 3 or higher) and/or opportunistic infections; hepatic function abnormality meeting the definition of Hy's Law; malignant neoplasm. (CTCAE Grade 3=Severe; Grade 4=Life-threatening; Grade 5=Fatal.)

Secondary Endpoints
Pharmacokinetics (PK) of VIB4920: Maximum Observed Concentration (Cmax)
Predose (within 30 minutes prior to start of infusion), and within 10 minutes of the end of infusion on Days 1 (Dose 1), 15 ± 1 day (d; Dose 2), 29 ± 3d (Dose 3), 57 ± 3d (Dose 4), and Days 85 ± 3d, 113 ± 5d, 141 ± 5d, 169 ± 5d, 197 ± 7d, 225 ± 7d
PK of VIB4920: Time to Cmax (Tmax)
Predose (within 30 minutes prior to start of infusion), and within 10 minutes of the end of infusion on Days 1 (Dose 1), 15 ± 1 day (d; Dose 2), 29 ± 3d (Dose 3), 57 ± 3d (Dose 4), and Days 85 ± 3d, 113 ± 5d, 141 ± 5d, 169 ± 5d, 197 ± 7d, 225 ± 7d
PK of VIB4920: Area Under the Concentration-Time Curve From Time 0 to the Last Quantifiable Concentration (AUClast)
Predose (within 30 minutes prior to start of infusion), and within 10 minutes of the end of infusion on Days 1 (Dose 1), 15 ± 1 day (d; Dose 2), 29 ± 3d (Dose 3), 57 ± 3d (Dose 4), and Days 85 ± 3d, 113 ± 5d, 141 ± 5d, 169 ± 5d, 197 ± 7d, 225 ± 7d
Unlock Study Endpoints
Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
VIB4920 1500 mg 4 TimesEXPERIMENTALParticipants receive intravenous (IV) infusion of VIB4920 1500 mg on Days 1, 15, 29, and 57
VIB4920 1500 mg TwiceEXPERIMENTALParticipants receive IV infusion of VIB4920 1500 mg on Days 1 and 57, placebo on Days 15 and 29.
VIB4920 3000 mg TwiceEXPERIMENTALParticipants receive IV infusion of VIB4920 3000 mg on Days 1 and 57, placebo on Days 15 and 29.
VIB4920 3000 mg OnceEXPERIMENTALParticipants receive IV infusion of VIB4920 3000 mg on Day 1 and placebo on Days 15, 29, and 57.
PlaceboPLACEBO_COMPARATORParticipants receive IV infusion of placebo matched to VIB4920 on Days 1, 15, 29, and 57.
Interventions
NameTypeDescription
VIB4920DRUGliquid for IV infusion following dilution in normal saline
PlaceboDRUG0.9% saline for IV infusion
Unlock Study Design Details
Eligibility Criteria
Age Range18 Years — 99 Years
SexALL
Healthy VolunteersNo
Study Sites25

Principal Inclusion Criteria: 1. Male or female adults, \>= 18 years of age at time of informed consent. 2. Diagnosed with RA according to the European League Against Rheumatism/American College of Rheumatology (EULAR/ACR) 2010 criteria \>= 6 months prior to screening. 3. Disease Activity Score in ...

Countries:United StatesPoland
Unlock Eligibility Criteria