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

NCT03330418 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 178

Last updated 2026-04-13

No results posted yet for this study

Summary

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

Conditions

  • Neuromyelitis Optica Spectrum Disorders

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.

Sponsors & Collaborators

  • RemeGen Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • xianhao Xu · Beijing 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
2018-01-29
Primary Completion
2026-04-03
Completion
2026-04-03

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs

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 NCT03330418 on ClinicalTrials.gov