NCT04163991

A Study to Evaluate the Safety and Efficacy of VIB4920 in Participants With Rheumatoid Arthritis

A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Mechanistic Insight and Dosage Optimization Study of the Efficacy and Safety of VIB4920 in Patients With Rheumatoid Arthritis (RA)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 78 (actual)
• Sponsor: Amgen · Industry
• Sex: All
• Age: 18 Years – 99 Years
• Healthy volunteers: Not accepted

Summary

The purpose of the study is to evaluate the efficacy, safety, and pharmacokinetics (PK) of VIB4920 (formerly MEDI4920) in adult participants with rheumatoid arthritis (RA).

Detailed description

The overall study period will be approximately 337 days. After a screening period of up to 28 days, the participants will be randomized in a 1:1:1:1:1 ratio to receive intravenous dose of VIB4920 and/or placebo in 5 cohorts. Participants are to be followed on their stable background anti-RA therapy at least through 12 weeks (Day 85), at which time rescue therapy may be instituted. All participants will be followed at least through the primary (interim) analysis (Day 113), and those who have not instituted rescue therapy will be followed through Day 309 to determine the duration of clinical response. The primary analysis will be after all participants have completed Day 113, and the final analysis will be after all participants have completed follow-up. Study with completed results acquired from Horizon in 2024.

Conditions

• Rheumatoid Arthritis

Interventions

Type	Name	Description
DRUG	VIB4920	liquid for IV infusion following dilution in normal saline
DRUG	Placebo	0.9% saline for IV infusion

Timeline

• Start date: 2019-12-09
• Primary completion: 2021-12-28
• Completion: 2021-12-28
• First posted: 2019-11-15
• Last updated: 2024-12-17
• Results posted: 2023-02-14

Locations

25 sites across 2 countries: United States, Poland

Regulatory

• FDA-regulated drug study