ClinicalTrials.gg
TerminatedNCT03330418Updated Apr 13, 2026

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

A Phase 3 interventional study of Placebo and RC18 160 mg in Neuromyelitis Optica Spectrum Disorders, sponsored by RemeGen Co., Ltd.. Terminated at 1 site in China. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-04-13.

Sponsored by RemeGen Co., Ltd. · Phase 3, Interventional, and Treatment

Why this study was terminated
Sponsor Strategic Priority Adjustment
Phase
Phase 3
Study type
Interventional
Enrollment
178
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-13

Among 72 studies in Neuromyelitis Optica with a site in China — 37 open to participants now, 43 under way, 7 of them phase 3. Neuromyelitis Optica · China.

Enrollment
4th of 51
178 · median 23
Started
2018
with 2 others
Phase 3
6 of 72
3 open now
Registered
7th of 72
by date

Among the 72 studies in Neuromyelitis Optica with a site in China, this one is the 4th largest by enrollment of the 51 interventional ones that give a count, is one of 3 that started in 2018, is one of 6 in phase 3, and was the 7th registered.

Neuromyelitis Optica

178 studies on the registry are indexed under Neuromyelitis Optica; 78 are open to participants now.

Browse Neuromyelitis Optica studies →

Open to participants now

37 of the 72 studies in Neuromyelitis Optica with a site in China are open now. Recruiting first, the newest first:

32 more — sign in →

All 37 open studies →

A study can be open while its sites in China have not opened yet or have stopped. Only those recruiting at a site in China →

Who these studies take

Of the 50 Neuromyelitis Optica studies recruiting now, 29 (58%) set no upper age limit and 16 (32%) stop at 75 or younger; 11 take children under 18; 9 take healthy volunteers.

This study: 18 Years to 65 Years · all sexes · no healthy volunteers.

The full table on the hub →

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02

Study summary

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

03

Conditions studied

  • Neuromyelitis Optica Spectrum Disorders

Browse trials for

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 during the study period (women of childbearing age)
  • Voluntarily signed

Exclusion criteria

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 class IV heart failure
  • Patients can't accept magnetic resonance imaging inspection during the trial.
  • Infection with herpes zoster or virus at the screening;
  • The anti- virus (anti-HCV) of patients show positive;
  • Investigator considers candidates not appropriating for the study.
Terms in these criteria, in plain language(5)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

NYHA class (heart failure)

The New York Heart Association’s four classes of how much heart failure limits physical activity.

I
No limits: ordinary activity causes no undue tiredness or breathlessness.
II
Slight limits: comfortable at rest, ordinary activity causes symptoms.
III
Marked limits: comfortable at rest, less than ordinary activity causes symptoms.
IV
Symptoms even at rest; any activity makes them worse.

Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

Hepatitis C tests

Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.

After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.

05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
178 participants (actual)

Study arms

  • 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

  • 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

Interventions

  • BiologicalPlacebo

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

  • BiologicalRC18 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.

06

What researchers measure

Primary outcomes

  1. Time to first relapse after randomization

    Time frame: 144 weeks

Secondary outcomes

  1. 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.

    Time frame: 144 weeks

  2. 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

07

Study locations

1 site
  • Beijing Hospital
    Beijing, Beijing Municipality, China
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Jan 2018 to primary completion in Apr 2026, 98 months.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 31, 2017
First posted
Nov 6, 2017
StartActual
Jan 29, 2018
Primary completionActual
Apr 3, 2026
CompletionActual
Apr 3, 2026
Last update
Apr 13, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Apr 13, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT03330418
Lead sponsor
RemeGen Co., Ltd.
Responsible party
Sponsor
First posted
Nov 6, 2017
Start date
Jan 29, 2018
Primary completion
Apr 3, 2026
Completion
Apr 3, 2026
Last update
Apr 13, 2026

Study contacts

xianhao Xu
principal investigator · Beijing Hospital

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.

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Discussion

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Studies of the drug tested here: Telitacicept

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