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TERMINATED
NCT03330418
PHASE3

A Phase III Study of TACI-antibody Fusion Protein Injection (RC18) in Subjects With Neuromyelitis Optica Spectrum Disorders

Sponsor: RemeGen Co., Ltd.

View on ClinicalTrials.gov

Summary

The purpose of this study is to initially observe the safety and effectivity of RC18 in Participants with Neuromyelitis Optica Spectrum Disorders.

Official title: A Phase III Study of RC18, a Recombinant Human B Lymphocyte Stimulator Receptor:Immunoglobulin G( IgG ) Fc Fusion Protein for Injection for the Treatment of Subjects With Neuromyelitis Optica Spectrum Disorders.

Key Details

Gender

All

Age Range

18 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

178

Start Date

2018-01-29

Completion Date

2026-04-03

Last Updated

2026-04-13

Healthy Volunteers

No

Interventions

BIOLOGICAL

Placebo

Starting with the forty-ninth dose,the trial went into the open phase. All participants were treated with the test drugs.

BIOLOGICAL

RC18 160 mg

In the Phase B,the researchers can adjust the dose of RC18 according to the subjects' willingness and recurrence, but the maximum dose of single dose should not exceed 320g.

Locations (1)

Beijing Hospital

Beijing, Beijing Municipality, China