NCT03330418

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

Terminated Phase 3 Last updated 13 April 2026

What this trial tests

Phase 3 trial testing Placebo in Neuromyelitis Optica Spectrum Disorders in 178 participants. Terminated before completion.

Timeline

29 January 2018

Primary endpoint
3 April 2026

3 April 2026

Quick facts

Lead sponsor	RemeGen Co., Ltd.
Phase	Phase 3
Status	Terminated
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	178
Start date	29 January 2018
Primary completion	3 April 2026
Estimated completion	3 April 2026
Sites	1 location across China

Drugs / interventions tested

• Placebo
• RC18 160 mg — full drug profile →

Conditions studied

• Neuromyelitis Optica Spectrum Disorders — all drugs for Neuromyelitis Optica Spectrum Disorders →

Sponsor

RemeGen Co., Ltd. — full company profile →

Who can join

Adults 18 to 65, any sex, with Neuromyelitis Optica Spectrum Disorders. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. B cell depletion therapies in autoimmune disease: advances and mechanistic insights.
   Lee DSW, Rojas OL, Gommerman JL. · · 2021 · cited 496× · PMID 33324003 · DOI 10.1038/s41573-020-00092-2
2. Neuromyelitis optica spectrum disorders: from pathophysiology to therapeutic strategies.
   Carnero Contentti E, Correale J. · · 2021 · cited 202× · PMID 34530847 · DOI 10.1186/s12974-021-02249-1
3. B cell targeted therapies in inflammatory autoimmune disease of the central nervous system.
   Furman MJ, Meuth SG, Albrecht P, Dietrich M, et al · · 2023 · cited 24× · PMID 36969208 · DOI 10.3389/fimmu.2023.1129906
4. Treatment and Relapse Prevention of Typical and Atypical Optic Neuritis.
   Saitakis G, Chwalisz BK. · · 2022 · cited 9× · PMID 36077167 · DOI 10.3390/ijms23179769
5. B Cells and Antibodies as Targets of Therapeutic Intervention in Neuromyelitis Optica Spectrum Disorders.
   Traub J, Husseini L, Weber MS. · · 2021 · cited 9× · PMID 33419217 · DOI 10.3390/ph14010037
6. Targeting Neuromyelitis Optica Pathogenesis: Results from Randomized Controlled Trials of Biologics.
   Cacciaguerra L, Tortorella P, Rocca MA, Filippi M. · · 2021 · cited 6× · PMID 33909234 · DOI 10.1007/s13311-021-01055-0
7. Dual BLyS/APRIL targeted therapy with telitacicept in rituximab-refractory SLE-associated neuromyelitis optica spectrum disorder: a case report.
   Dai M, Huang C, Zhou M, Leong PY, et al · · 2025 · cited 4× · PMID 40491913 · DOI 10.3389/fimmu.2025.1602800
8. Monoclonal antibody therapies for aquaporin-4-immunoglobulin G-positive neuromyelitis optica spectrum disorder and myelin oligodendrocyte glycoprotein antibody-associated disease.
   Tisavipat N, Juan HY, Chen JJ. · · 2024 · cited 4× · PMID 38628414 · DOI 10.4103/sjopt.sjopt_102_23