Study of Recombinant Human B Lymphocyte(RC18) Administered Subcutaneously to Subjects With Systemic Lupus Erythematosus(SLE)

Summary

The purpose of this study is to initially access the safety and effectivity of RC18 combined with standard treatment and Placebo combined with standard therapy in subjects with Moderate to severe SLE.

Timeline

Start

2019-10-16

Primary completion

2022-04-24

Completion

2022-06-30

Outcome

Met primary endpoint

paper response on the modified SRI-4 than those receiving placebo (67.1% vs. 32.7%; adjusted difference, 34.5 percentage points; 95% confidence interval [CI], 24.3 to 44.7; P<0.001). PMID 41092329 ↗

Publications

• van Vollenhoven RF, Wang L, Merrill JT, Liu Y, Bao C, Li F, Hu J, Huang C, Zhao J, Huang C, Mo H, Wei W, Lu F, Li J, Zhao D, Wang W, Li L, Zuraw Q, Wang X, Wang X, Fang J, Zhang F; 18C010 Trial Investigators. A Phase 3 Trial of Telitacicept for Systemic Lupus Erythematosus. N Engl J Med. 2025 Oct 16;393(15):1475-1485. doi: 10.1056/NEJMoa2414719.

Drugs

Indications