Study of RC18 Administered Subcutaneously to Subjects With Systemic Lupus Erythematosus(SLE)

Phase 2 Completed 249 enrolled RemeGen Co., Ltd.

RandomizedParallel-groupQuadruple-blindTreatment

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, Besides ,to provide dose basis for follow-up clinical trials.

Timeline

Start: 2015-12
Primary completion: 2019-06-11
Completion: 2019-07-09

Outcome

Met primary endpoint

paper This phase 2b clinical trial met the primary endpoint. PMID 38129117 ↗

Publications

Wu D, Li J, Xu D, Merrill JT, van Vollenhoven RF, Liu Y, Hu J, Li Y, Li F, Huang C, Wang G, Li X, Zhao J, Zhao D, Huang C, Liu H, Wei W, Shi G, Lu F, Zuo X, Bi L, Li Z, Wang X, Zhang M, Tie N, Li J, Mo H, Fang J, Bao C, Zhang F. Telitacicept in patients with active systemic lupus erythematosus: results of a phase 2b, randomised, double-blind, placebo-controlled trial. Ann Rheum Dis. 2024 Mar 12;83(4):475-487. doi: 10.1136/ard-2023-224854.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	RC18	Protein / enzyme biologic	80 mg	Subcutaneous
Subject	RC18	Protein / enzyme biologic	160 mg	Subcutaneous
Subject	RC18	Protein / enzyme biologic	240 mg	Subcutaneous
Comparator	Azathioprine	Small molecule	—	—
Comparator	Cyclophosphamide	Other / unclassified	—	—
Comparator	Cyclosporine	Peptide	—	—
Comparator	Leflunomide	Small molecule	—	—
Comparator	Methotrexate	Small molecule	—	—
Comparator	Mycophenolate Sodium	Unknown	—	—
Comparator	Tacrolimus	Small molecule	—	—