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

PHASE3CompletedINTERVENTIONAL
Enrollment

335

Participants

Timeline

Start Date

October 16, 2019

Primary Completion Date

April 24, 2022

Study Completion Date

June 30, 2022

Conditions
Systemic Lupus Erythematosus
Interventions
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,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,Tacrolimus ,ciclosporin )

Trial Locations (1)

Unknown

Remegen,ltd., Yantai

All Listed Sponsors
lead

RemeGen Co., Ltd.

INDUSTRY

NCT04082416 - Study of Recombinant Human B Lymphocyte(RC18) Administered Subcutaneously to Subjects With Systemic Lupus Erythematosus(SLE) | Biotech Hunter | Biotech Hunter