CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 335 enrolled
Drug / intervention
Placebo plus standard therapy +1 morebiological
Likely dose
RC18 160 mg plus standard therapyfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04082416
NCT04082416Phase 3Completed

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

RemeGen Co., Ltd.·interventional·Posted Sep 9, 2019·Updated May 11, 2023

In Brief

A Phase 3 clinical trial evaluating Placebo plus standard therapy and RC18 160 mg plus standard therapy for Systemic Lupus Erythematosus. Completed, enrolled 335 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesChina
Collaborators--

Timeline

Phase 3CompletedFinished
2020202120222023202420252026
First PostedSep 9, 2019
Enrollment StartOct 16, 2019
Primary CompletionApr 24, 2022
Study CompletionJun 30, 2022
TodayJul 2, 2026
Enrollment to primary: 2.5 yearsPosted 6.8 years ago

Interventions

Placebo plus standard therapybiological

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 )

RC18 160 mg plus standard therapybiological

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 )