Study of VIB7734 for the Treatment of Moderate to Severely Active SLE

Summary

A Phase 2 Randomized, Double-Blind, Placebo-Controlled Efficacy and Safety Study of VIB7734 for the Treatment of Moderate to Severely Active Systemic Lupus Erythematosus in approximately 195 participants. The study duration will be 48 weeks, with a safety follow-up through week 56.There will be 3 parallel arms - 2 active treatment and 1 placebo.

Timeline

Start

2021-05-28

Primary completion

2023-05-16

Completion

2023-06-09

Outcome

Missed primary endpoint

registry analysis (superiority test); Placebo vs Daxdilimab 200 mg Q4W; p =0.7474; Rate Difference 2.8 (90% CI -11.4 to 17.0); Regression, Logistic NCT04925934 ↗

registry analysis (superiority test); Placebo vs Daxdilimab 200 mg Q12W; p =0.9942; Rate Difference -0.1 (90% CI -14.2 to 14.1); Regression, Logistic NCT04925934 ↗

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Daxdilimab	Monoclonal antibody	—	Subcutaneous

Indications