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

NCT04082416 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 335

Last updated 2023-05-11

No results posted yet for this study

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.

Conditions

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 )

Sponsors & Collaborators

  • RemeGen Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Fengchun Zhang, M.D. · Peking Union Medical College Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-10-16
Primary Completion
2022-04-24
Completion
2022-06-30

Countries

  • China

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04082416 on ClinicalTrials.gov