A Study to Evaluate the Efficacy and Safety of Dapirolizumab Pegol in Study Participants With Moderately to Severely Active Systemic Lupus Erythematosus

Summary

The purpose of this study is to evaluate the ability of dapirolizumab pegol (DZP) as an add-on treatment to standard of care (SOC) medication to achieve clinically relevant long term improvement of moderate to severe disease activity.

Timeline

Start

2020-08-12

Primary completion

2024-05-22

Completion

2024-06-04

Outcome

Met primary endpoint

registry analysis (superiority test); PBO+SOC vs DZP+SOC; p = 0.0110; Difference in Proportions (%) 14.6 (95% CI 3.3 to 25.8) NCT04294667 ↗

paper A significantly greater proportion of patients receiving dapirolizumab pegol (50% [103/208]) versus placebo (35% [37/107]) had BICLA response at week 48 PMID 42214397 ↗

release “Phase 3 PHOENYCS GO study met the primary endpoint demonstrating clinical improvement in moderate-to-severe systemic lupus erythematosus” biogen.com ↗

release “Phase 3 PHOENYCS GO study, demonstrating statistically significant improvement in disease activity at Week 48” biogen.com ↗

Publications

• Clowse MEB, Isenberg DA, Merrill JT, Dorner T, Petri M, Vital EM, Morand EF, Touma Z, Askanase AD, Ioannou Y, Brookes S, Gaiha-Rohrbach J, Koch ED, Zibian N, Martin C, Jimenez T, Nelde A, Stach C; PHOENYCS GO Study Investigators' Group. Efficacy and safety of the CD40 ligand inhibitor dapirolizumab pegol in systemic lupus erythematosus (PHOENYCS GO): a randomised, double-blind, placebo-controlled, phase 3 trial. Lancet. 2026 Jun 6;407(10545):2291-2304. doi: 10.1016/S0140-6736(26)00691-4. Epub 2026 May 29.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Dapirolizumab pegol	Monoclonal antibody	24 mg/kg	Intravenous

Indications