NCT04129164

A Study to Evaluate the Efficacy and Safety of VIB4920 in Participants With Sjögren's Syndrome

A Phase 2 Randomized, Double-blind, Placebo-controlled, Proof of Concept Study to Evaluate the Efficacy and Safety of VIB4920 in Subjects With Sjögren's Syndrome (SS)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 183 (actual)
• Sponsor: Amgen · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The purpose of the study is to evaluate the efficacy, safety, and tolerability of VIB4920 (formerly MEDI4920) in adult participants with Sjögren's Syndrome (SS).

Detailed description

The study will enrol 2 SS populations: Population 1 will include participants with moderate to high systemic disease activity defined by European League Against Rheumatism (EULAR) Sjögren's Syndrome Disease Activity Index (ESSDAI) \>= 5; Population 2 will include participants with moderate to severe subjective symptoms defined by EULAR Sjögren's Syndrome Patient Reported Index (ESSPRI) score \>= 5 and residual stimulated salivary flow but with mild systemic disease activity defined by ESSDAI score \< 5. This study will include 3 periods: screening (4 weeks), treatment period (40 Weeks) and follow-up period (12 weeks). In the treatment period, participants from each of the populations will be randomized at 1:1 ratio to receive intravenous (IV) dose of VIB4920 or placebo (Stage I). After completion of Stage I, participants randomized to VIB4920 in Stage I will receive placebo and participants randomized to placebo in Stage I will receive VIB4920 (Stage II). Participants who had study drug discontinuation will not be eligible for treatment during Stage II. All participants will be followed for at least 12 weeks after their last dose of study drug administration. Study acquired from Horizon in 2024.

Conditions

• Sjögren's Syndrome

Interventions

Type	Name	Description
DRUG	VIB4920	Intravenous Dose 1.
DRUG	Placebo	Intravenous dose matched to VIB4920.

Timeline

• Start date: 2019-12-09
• Primary completion: 2022-09-01
• Completion: 2023-03-10
• First posted: 2019-10-16
• Last updated: 2025-04-30
• Results posted: 2025-04-30

Locations

62 sites across 12 countries: United States, Argentina, France, Hungary, India, Italy, Mexico, Peru, Poland, South Korea, Taiwan, United Kingdom

Regulatory

• FDA-regulated drug study