NCT02780388

A Phase 1b Study of MEDI4920 in Participants With Adult-onset Rheumatoid Arthritis

A Phase 1b Randomized, Double-blind, Placebo-controlled Multiple-ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Immunogenicity, Pharmacodynamics, and Clinical Response of MEDI4920 in Subjects With Adult-onset Rheumatoid Arthritis

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 57 (actual)
• Sponsor: Amgen · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine whether VIB4920 (formerly MEDI4920) is safe and well tolerated in participants with adult-onset rheumatoid arthritis (RA).

Detailed description

Study with completed results acquired from Horizon in 2024. Originally Viela Bio was the sponsor.

Conditions

• Adult Onset Rheumatoid Arthritis

Interventions

Type	Name	Description
DRUG	VIB4920	Participants will receive a single IV dose of VIB4920 Q2W from Day 1 up to 12 weeks.
OTHER	Placebo	Participants will receive a single IV dose of placebo matched to VIB4920 Q2W from Day 1 up to 12 weeks.

Timeline

• Start date: 2016-05-12
• Primary completion: 2018-05-21
• Completion: 2018-08-09
• First posted: 2016-05-23
• Last updated: 2024-12-27
• Results posted: 2019-09-16

Locations

12 sites across 2 countries: United States, Poland

Regulatory

• FDA-regulated drug study