NCT02885610

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

A Phase IIb , Placebo-Controlled ,Multi-Center, Randomized, Double-Blind, Dose-explorating Trial of RC18,a Recombinant Human B Lymphocyte Stimulating Factor Receptor-Antibody Fusion Protein in Subjects With Systemic Lupus Erythematosus (SLE).

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 249 (actual)
• Sponsor: RemeGen Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Systemic Lupus Erythematosus

Interventions

Type	Name	Description
BIOLOGICAL	Placebo plus standard therapy	Standard therapy comprises any of the following (alone or in combination): corticosteroids, antimalarials, non-steroidal anti-inflammatory drugs (NSAIDs), and immunosuppressive and immunomodulator therapy(i.e.,azathioprine,mycophenolate ,cyclophosphamide,methotrexate,leflunomide, Tacrolimus ,ciclosporin )
BIOLOGICAL	RC18 80 mg plus standard therapy	Standard therapy comprises any of the following (alone or in combination): corticosteroids, antimalarials, non-steroidal anti-inflammatory drugs (NSAIDs), and immunosuppressive and immunomodulator herapy(i.e.,azathioprine,mycophenolate ,cyclophosphamide,methotrexate,leflunomide, Tacrolimus ,ciclosporin )
BIOLOGICAL	RC18 160 mg plus standard therapy	Standard therapy comprises any of the following (alone or in combination): corticosteroids, antimalarials, non-steroidal anti-inflammatory drugs (NSAIDs), and immunosuppressive and immunomodulator herapy(i.e.,azathioprine,mycophenolate ,cyclophosphamide,methotrexate,leflunomide, Tacrolimus ,ciclosporin )
BIOLOGICAL	RC18 240 mg plus standard therapy	Standard therapy comprises any of the following (alone or in combination): corticosteroids, antimalarials, non-steroidal anti-inflammatory drugs (NSAIDs), and immunosuppressive and immunomodulator therapy(i.e.,azathioprine,mycophenolate ,cyclophosphamide,methotrexate,leflunomide, Tacrolimus ,ciclosporin )

Timeline

• Start date: 2015-12-01
• Primary completion: 2019-06-11
• Completion: 2019-07-09
• First posted: 2016-08-31
• Last updated: 2020-03-04

Locations

1 site across 1 country: China