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

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).

Timeline

Start

2019-12-09

Primary completion

2021-12-28

Completion

2021-12-28

Outcome

Met primary endpoint

registry analysis (superiority test); Placebo vs VIB4920 3000 mg Once; p = 0.0296; Least Squares (LS) Mean Difference -0.84 (90% CI -1.47 to -0.21) NCT04163991 ↗

paper CONCLUSIONS: DAZ treatment for all dosage regimens significantly reduced DAS28-CRP at day 113 relative to PBO. PMID 37541743 ↗

Publications

• Kivitz A, Wang L, Alevizos I, Gunsior M, Falloon J, Illei G, St Clair EW. The MIDORA trial: a phase II, randomised, double-blind, placebo-controlled, mechanistic insight and dosage optimisation study of the efficacy and safety of dazodalibep in patients with rheumatoid arthritis. RMD Open. 2023 Aug;9(3):e003317. doi: 10.1136/rmdopen-2023-003317.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Dazodalibep	Protein / enzyme biologic	1500 mg	Intravenous
Subject	Dazodalibep	Protein / enzyme biologic	3000 mg	Intravenous

Indications