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

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.

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

Study Overview

• Status: Terminated
• Conditions: Neuromyelitis Optica Spectrum Disorders
• Intervention / Treatment: Biological: Placebo; Biological: RC18 160 mg

• Study Type: Interventional
• Enrollment (Actual): 178
• Phase: Phase 3

Contacts and Locations

Study Locations

• China
  • Beijing Municipality
    • Beijing, Beijing Municipality, China
      • Beijing Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Meet the 2015 international consensus diagnostic criteria for Neuromyelitis Optica Spectrum Disorders and astrocyte water channel aquaporin-4 (AQP4) antibody positivity.
• EDSS 0-7.5
• Clinical evidence of at least 2 relapses within the first two years of randomization and/ or 1 relapse within the first one year of randomization
• Consent to use effective contraception during the study period (women of childbearing age)
• Voluntarily signed informed consent

Exclusion Criteria:

• Abnormal laboratory parameters need to be excluded, including but not limited to:
• Currently suffering from active hepatitis or serious liver disease and medical history
• Patients were treated with rituximab or other monoclonal antibodies within 6 months prior to randomization .
• Any concomitant disease other than neuromyelitis optica（NMO）/ neuromyelitis optica Spectrum disorders（NMOSD）that required treatment with lucocorticoid.
• pregnant , lactating women and men or women who have birth plans during the research;
• Have a history of allergic reaction to contrast agent for parenteral administration and human biological medicines.
• Receipt of intravenous immune globulin （ IVIG） within 28 days prior to randomization.
• Receipt of any of the following prior to randomization: Azathioprine,Cyclosporin, Methotrexate Mitoxantrone,Cyclophosphamide,Tocilizumab,Tacrolimus,Mycophenolate,and Patients discontinued more than 5 times the half-life of the drug before they could get into the group .If the patients taking leflunomide and teriflunomide,they should need to take colestyramine for elution.
• Have participated in any clinical trial in the first 28 days of the initial screening or 5 times half-life period of the study compound (taking shorter time ).
• The patients have severe psychiatric symptoms and are not compatible with clinical studies
• Malignant tumor patients ;
• patients experienced any of the following events within 12 weeks before screening : myocardial infarction, unstable ischemic heart disease, stroke, or New York Heart Association class IV heart failure
• Patients can't accept magnetic resonance imaging inspection during the trial.
• Infection with herpes zoster or HIV virus at the screening;
• The anti-hepatitis C virus （anti-HCV） of patients show positive;
• Investigator considers candidates not appropriating for the study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Placebo Comparator; Participants received placebo weekly administered subcutaneously for 48 times in the double-blind treatment period.Once the participants relapse,they should advance to the open phase.All participants were treated with the test drugs.	Biological: Placebo; Starting with the forty-ninth dose,the trial went into the open phase. All participants were treated with the test drugs.
Experimental: RC18 160 mg; Patients received the test group RC18 160mg weekly administered subcutaneously for 48 times.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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Time to first relapse after randomization	144 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from Baseline in Expanded Disability Status Scale (EDSS) Score at week 4,8,12,24,36,48,60,72,96,120,144	The EDSS is an ordinal clinical rating scale ranging from 0 (normal neurologic examination) to 10 (death) in half-point increments.	144 weeks
Change from Baseline in Hauser Ambulation Index at week 4,8,12,24,36,48,60,72,96,120,144		week 4,8,12,24,36,48,60,72,96,120,144

Collaborators and Investigators

• Sponsor: RemeGen Co., Ltd.
• Investigators: Principal Investigator: xianhao Xu, Beijing Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 29, 2018
• Primary Completion (Actual): April 3, 2026
• Study Completion (Actual): April 3, 2026

Study Registration Dates

• First Submitted: October 31, 2017
• First Submitted That Met QC Criteria: October 31, 2017
• First Posted (Actual): November 6, 2017

Study Record Updates

• Last Update Posted (Actual): April 13, 2026
• Last Update Submitted That Met QC Criteria: April 8, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Autoimmune Diseases; Immune System Diseases; Eye Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Myelitis, Transverse; Optic Neuritis; Optic Nerve Diseases; Cranial Nerve Diseases; Neuromyelitis Optica; RC-18
• Other Study ID Numbers: C009NMOSDCLLI

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No