A Proof-of-concept Study of the Efficacy and Safety of Nipocalimab in Participants With Active Rheumatoid Arthritis

Summary

The purpose of this study is to evaluate the efficacy and safety of nipocalimab versus placebo in participants with moderate to severe active rheumatoid arthritis (RA).

Timeline

Start

2021-10-14

Primary completion

2022-08-10

Completion

2022-08-10

Outcome

Missed primary endpoint

registry analysis (superiority test); Group 1: Placebo vs Group 2: Nipocalimab; p =0.224; Least square mean difference -0.45 (95% CI -1.17 to 0.28); ANCOVA NCT04991753 ↗

paper Although the primary endpoint did not reach statistical significance for nipocalimab versus placebo PMID 38942592 ↗

Publications

• Yu F, Myshkin E, Nguyen B, Bobadilla Mendez C, Cossu M, Fei K, Wang Q, Hubbard JJ, Campbell K, Ramchandren S, Rojo Cella R, Edwards R, Taylor PC, Gottenberg JE, Noaiseh G, Vu T, Antozzi C, Winthrop KL, Cuff CA, Loza MJ, Dimitrova D, Gao S. Effect of nipocalimab on IgG responses to vaccinations and viral infections in patients with IgG autoantibody-mediated diseases: Post hoc analyses of three randomized, placebo-controlled trials. Hum Vaccin Immunother. 2026 Dec;22(1):2664331. doi: 10.1080/21645515.2026.2664331. Epub 2026 May 5.
• Taylor PC, Schett G, Huizinga TW, Wang Q, Ibrahim F, Zhou B, Liva SG, Shaik JSB, Xiong Y, Leu JH, Panchakshari RA, Loza MJ, Ma K, Dhatt H, Rojo Cella R, Karyekar CS, Cuff CA, Gao S, Fei K. Nipocalimab, an anti-FcRn monoclonal antibody, in participants with moderate to severe active rheumatoid arthritis and inadequate response or intolerance to anti-TNF therapy: results from the phase 2a IRIS-RA study. RMD Open. 2024 Jun 28;10(2):e004278. doi: 10.1136/rmdopen-2024-004278.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Nipocalimab	Monoclonal antibody	15 mg/kg	Intravenous

Indications