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

PHASE2CompletedINTERVENTIONAL
Enrollment

249

Participants

Timeline

Start Date

December 31, 2015

Primary Completion Date

June 11, 2019

Study Completion Date

July 9, 2019

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,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 )

Trial Locations (1)

Unknown

Peking Union Medical College Hospital, Beijing

All Listed Sponsors
lead

RemeGen Co., Ltd.

INDUSTRY

NCT02885610 - Study of RC18 Administered Subcutaneously to Subjects With Systemic Lupus Erythematosus(SLE) | Biotech Hunter | Biotech Hunter