Trials / Terminated
TerminatedNCT03330418
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.
- Status
- Terminated
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 178 (actual)
- Sponsor
- RemeGen Co., Ltd. · Industry
- Sex
- All
- Age
- 18 Years – 65 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to initially observe the safety and effectivity of RC18 in Participants with Neuromyelitis Optica Spectrum Disorders.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | Placebo | 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. |
Timeline
- Start date
- 2018-01-29
- Primary completion
- 2026-04-03
- Completion
- 2026-04-03
- First posted
- 2017-11-06
- Last updated
- 2026-04-13
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT03330418. Inclusion in this directory is not an endorsement.