A Study of Nipocalimab in Adults With Primary Sjogren's Syndrome (pSS)

Summary

The purpose of this study is to evaluate the efficacy and safety of nipocalimab in participants with primary Sjogren's syndrome (pSS) versus placebo.

Timeline

Start

2021-09-21

Primary completion

2023-10-23

Completion

2023-11-30

Outcome

Met primary endpoint

paper The nipocalimab 15 mg/kg group had a significant reduction in ClinESSDAI score at week 24 versus the placebo group PMID 41284548 ↗

paper least squares mean difference -2·65, 90% CI -4·03 to -1·28; p=0·0018 PMID 41284548 ↗

release “Results from the Phase 2 DAHLIAS study of nipocalimab in SjD show nipocalimab met the primary endpoint” jnj.com ↗

release “met its primary endpoint in the Phase 2 DAHLIAS study” jnj.com ↗

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.
• Noaiseh G, Sivils KL, Campbell K, Idokogi J, Lo KH, Liva SG, Leu JH, Dhatt H, Ma K, Leonardo S, Li H, Hubbard JJ, Gottenberg JE. Efficacy and safety of nipocalimab in patients with moderate-to-severe Sjogren's disease (DAHLIAS): a randomised, phase 2, placebo-controlled, double-blind trial. Lancet. 2025 Nov 22;406(10518):2435-2448. doi: 10.1016/S0140-6736(25)01430-8. Epub 2025 Oct 24.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Nipocalimab	Monoclonal antibody	5 mg/kg	Intravenous
Subject	Nipocalimab	Monoclonal antibody	15 mg/kg	Intravenous

Indications