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

NCT03330418 | Terminated Phase 3 DMC

• 1 other identifier: C009NMOSDCLLI
• Study Type: interventional
• Target: 178
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Time to first relapse after randomization

  144 weeks

Secondary Outcomes (2)

• Change from Baseline in Expanded Disability Status Scale (EDSS) Score at week 4,8,12,24,36,48,60,72,96,120,144

  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

Study Arms (2)

Placebo Comparator

EXPERIMENTAL

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

RC18 160 mg

EXPERIMENTAL

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

Interventions

Placebo BIOLOGICAL

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

Placebo Comparator

RC18 160 mg BIOLOGICAL

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.

RC18 160 mg

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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;

Sponsors & Collaborators

• RemeGen Co., Ltd.: lead

Study Sites (1)

Beijing Hospital

Beijing, Beijing Municipality, China

Location

MeSH Terms

Conditions

Neuromyelitis Optica

Interventions

RC-18

Condition Hierarchy (Ancestors)

Myelitis, Transverse; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Optic Neuritis; Optic Nerve Diseases; Cranial Nerve Diseases; Demyelinating Diseases; Eye Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• xianhao Xu

  Beijing Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 31, 2017
• First Posted: November 6, 2017
• Study Start: January 29, 2018
• Primary Completion: April 3, 2026
• Study Completion: April 3, 2026
• Last Updated: April 13, 2026

Record last verified: 2026-04

Locations

CN (1)