New drug aims to stop relapses in rare brain disease
NCT ID NCT03330418
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tested an experimental drug called RC18 in 178 people with neuromyelitis optica spectrum disorders (NMOSD), a rare disease that causes inflammation in the eyes and spinal cord. The goal was to see if RC18 could prevent relapses and slow disability. Participants had to have had recent relapses and test positive for a specific antibody. The study was terminated early, so results are limited.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
-
178 people
The number who actually took part.
- Started
-
Jan 2018
- Finished
-
Apr 2026
- Lead sponsor
-
A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 to 65 years
- Sex
-
Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Neuromyelitis optica spectrum disorders are added.
By submitting, you agree to our Terms of use
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
Beijing Hospital
Beijing, Beijing Municipality, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can a gentle brain zapping boost memory in nerve diseases?
- New study hopes to find a simple test for MS diagnosis
- Massive italian MS registry aims to unlock secrets of the disease
- Silent attacks in NMOSD: new study aims to predict disability before it strikes
- New shot aims to stop devastating NMOSD Flare-Ups
- Could a zappy headband cure insomnia in MS patients?