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

Primary Purpose

Neuromyelitis Optica Spectrum Disorders

Status

Recruiting

Phase

Phase 3

Locations

China

Study Type

Interventional

Intervention

Placebo

RC18 160 mg

About this trial

This is an interventional treatment trial for Neuromyelitis Optica Spectrum Disorders

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Beijing HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Placebo Comparator

RC18 160 mg

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Time to first relapse after randomization

Secondary Outcome Measures

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.

Change from Baseline in Hauser Ambulation Index at week 4,8,12,24,36,48,60,72,96,120,144

Full Information

NCT ID

NCT03330418

First Posted

October 31, 2017

Last Updated

January 9, 2022

Sponsor

RemeGen Co., Ltd.

1. Study Identification

Unique Protocol Identification Number

NCT03330418

Brief Title

A Phase III Study of TACI-antibody Fusion Protein Injection (RC18) in Subjects 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.

Study Type

Interventional

2. Study Status

Record Verification Date

January 2022

Overall Recruitment Status

Recruiting

Study Start Date

January 29, 2018 (Actual)

Primary Completion Date

October 2023 (Anticipated)

Study Completion Date

October 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

RemeGen Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Neuromyelitis Optica Spectrum Disorders

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

166 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Placebo Comparator

Arm Type

Experimental

Arm Description

Arm Title

RC18 160 mg

Arm Type

Experimental

Arm Description

Intervention Type

Biological

Intervention Name(s)

Placebo

Intervention Description

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

Intervention Type

Biological

Intervention Name(s)

RC18 160 mg

Intervention Description

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.

Primary Outcome Measure Information:

Title

Time to first relapse after randomization

Time Frame

144 weeks

Secondary Outcome Measure Information:

Title

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

Description

The EDSS is an ordinal clinical rating scale ranging from 0 (normal neurologic examination) to 10 (death) in half-point increments.

Time Frame

144 weeks

Title

Change from Baseline in Hauser Ambulation Index at week 4,8,12,24,36,48,60,72,96,120,144

Time Frame

week 4,8,12,24,36,48,60,72,96,120,144

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Binghua Xiao

Phone

86-010-58076833

xiaosir522@163.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

xianhao Xu

Organizational Affiliation

Beijing Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Beijing Hospital

City

Beijing

State/Province

Beijing

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Xianhao Xu

Phone

010-65282171

bjyyxcc@bjhmoh.cn

12. IPD Sharing Statement

Learn more about this trial

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

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