Clinical trials: AQP4+ NMOSD
NMOSD, Neuromyelitis Optica Spectrum Disorders
Efficacy, Safety, PK, PD, and ADA of Eculizumab in Chinese Adults With NMOSD
The primary objective of this study is to evaluate the efficacy, safety, pharmacokinetics, pharmacodynamics, and immunogenicity of Eculizumab in Chinese Adults with Neuromyelitis Optica Spectrum Disorders (NMOSD).
- Trial name
- ECU-NMO-304 (NCT06724809)
- Testing
- eculizumab
- Where
- 7 sites in China
- Volunteers
- 21 people
- Sponsor
- Alexion Pharmaceuticals, Inc.
Neuromyelitis Optica Spectrum Disorder, NMOSD
A Study to Evaluate Pharmacokinetics, Efficacy, Safety, Tolerability, and Pharmacodynamics of Satralizumab in Pediatric Patients With Aquaporin-4 Antibody Positive Neuromyelitis Optica Spectrum Disorder (NMOSD)
This study will primarily evaluate the pharmacokinetics of satralizumab in pediatric patients aged 2-11 years with anti-aquaporin-4 (AQP4) antibody seropositive neuromyelitis optica spectrum disorder (NMOSD).
- Trial name
- SAkuraSun (NCT05199688)
- Testing
- Satralizumab
- Where
- 14 sites in United States, Argentina and 7 more
- Volunteers
- 8 people
- Sponsor
- Hoffmann-La Roche
NMO Spectrum Disorder
Monoclonal Antibody-Based Therapies for AQP4-Positive NMOSD
The primary objective of this registry study is to evaluate the therapeutic efficacy and safety profiles of distinct monoclonal antibody-based therapies for aquaporin-4 immunoglobulin G-seropositive neuromyelitis optica spectrum…
- Trial name
- NCT06885957
- Testing
- Mab Therapy
- Where
- China
- Volunteers
- 200 people
- Sponsor
- Tongji Hospital
NMOSD
Clinical Study to Evaluate the Effects of the Complement C5 Inhibitor Ravulizumab on Serum Neurofilament Light Chain (sNfL) and Glial Fibrillary Acidic Protein (sGFAP) Levels in Patients With Aquaporin-4-Positive (AQP4-Ab+) Neuromyelitis Optica Spectrum Disorder (NMOSD)
This is a nationwide observational study looking at how ravulizumab, a complement C5 inhibitor, affects blood biomarkers o sNfL and sGFAP in people with AQP4-antibody positive NMOSD.
- Trial name
- NCT06903130
- Testing
- Blood samples for sNfL and sGFAP levels
- Where
- Greece
- Volunteers
- 40 people
- Sponsor
- National and Kapodistrian University of Athens
AQP4+ NMOSD
A Safety and Tolerability Study of CC- 97540 (BMS-086353) in Anti-Aquaporin 4 Antibody Positive Neuromyelitis Optica Patients
The goal of this clinical trial is to find out if the investigational medicine BMS-986353 is safe and well tolerated in adults with anti-aquaporin-4 (AQP4) antibody-positive neuromyelitis optica spectrum disorder (NMOSD).
- Trial name
- NCT07573332
- Testing
- CC-97540 (BMS-986353), Fludarabine, Cyclophosphamide
- Where
- United States
- Volunteers
- 5 people
- Sponsor
- University of Texas Southwestern Medical Center
Neuromyelitis Optica Spectrum Disorder Attack
Therapy in the Acute Phase of NMOSD: A Multicenter Prospective Real-World Study
This project is a multi-center, prospective, real-world cohort study that collects clinical data of Chinese patients with AQP4-positive NMOSD in the acute stage.
- Trial name
- ETA/PETA-NMOSD (NCT07410039)
- Testing
- Eculizumab+IVMP, IVIG+IVMP, IVMP
- Where
- China
- Volunteers
- 200 people
- Sponsor
- Chinese PLA General Hospital
Neuromyelitis Optica Spectrum Disorder Relapse
Evaluate the Safety and Tolerability of CE211NS21 in Patients With AQP4-IgG-positive NMOSD Relapse
To evaluate the safety and tolerability of allogeneic bone marrow-derived mesenchymal stem cells (CE211NS21) in patients with severe anti-aquaporin-4-immunoglobulin G positive neuromyelitis optica spectrum disorder…
- Trial name
- NCT07595965
- Testing
- CE211NS21
- Volunteers
- 6 people
- Sponsor
- Corestemchemon, Inc.
Neuromyelitis Optica Spectrum Disease (NMOSD)
The Safety and Efficacy of KSVCBD Injection in Neuromyelitis Optica Spectrum Disorder.
KSVCBD injection is an in vivo Chimeric Antigen Receptor T-Cell (CAR-T cell) therapy product. This is a multi-center, single-arm, open-label, early exploratory clinical study.
- Trial name
- NCT07592754
- Testing
- KSVCBD injection
- Where
- China
- Volunteers
- 18 people
- Sponsor
- Chinese PLA General Hospital
Neuromyelitis Optica Spectrum Disorder, NMOSD
Registry of Patients With AQP4+ NMOSD Treated With Alexion C5 Inhibitor Therapies
Long-term, multicenter, multinational, observational, registry of patients with AQP4+ NMOSD that is designed to collect data on clinical outcomes and safety in patients prescribed Alexion C5 inhibitor therapies (C5IT).
- Conditions
- Neuromyelitis Optica Spectrum Disorder, NMOSD, AQP4+ NMOSD
- Trial name
- NCT05966467
- Where
- 33 sites in United States, Argentina and 6 more
- Volunteers
- 200 people
- Sponsor
- Alexion Pharmaceuticals, Inc.
Neuromyelitis Optica Spectrum Disorder
Treatment of Relapsed and/or Refractory AQP4-IgG Seropositive NMOSD by Tandem CAR T Cells Targeting CD19 and CD20
CAR-T therapy was proposed and has been recently used for cancer treatment. It has been hailed for its promising remission rates after early stage clinical trials for acute lymphoblastic leukemia.
- Trial name
- NCT03605238
- Testing
- Corticosteroids & tanCART19/20
- Where
- China
- Sponsor
- Chinese PLA General Hospital
Neuromyelitis Optica Spectrum Disorder
Ofatumumab in AQP4-IgG Seropositive NMOSD
This is an open-label, single-arm, multicentre prospective pilot study to assess the efficacy and safety of ofatumumab in patients with AQP4-IgG seropositive neuromyelitis optica spectrum disorder (NMOSD) in China.
- Trial name
- NCT05504694
- Testing
- Ofatumumab
- Where
- China
- Volunteers
- 5 people
- Sponsor
- Tang-Du Hospital
Neuromyelitis Optica Spectrum Disorder
Efficacy and Safety Study of Ravulizumab IV in Pediatric Participants With NMOSD
The primary purpose of this study is to evaluate the safety and efficacy of ravulizumab in pediatric participants with Neuromyelitis Optica Spectrum Disorder (NMOSD).
- Trial name
- NCT05346354
- Testing
- Ravulizumab
- Where
- 16 sites in United States, Canada and 5 more
- Volunteers
- 12 people
- Sponsor
- Alexion Pharmaceuticals, Inc.
Rare Diseases, Neuromyelitis Optica Spectrum Disorder (NMOSD)
Epidemiological Study of Treatment Approaches on AQP4-IgG Positive NMOSD in Russia
This is a multi-centre, retrospective-prospective, single-arm, non-interventional (observational) cohort study with secondary data collection within real-world settings of participants with AQP4-IgG positive NMOSD.
- Trial name
- NCT07247292
- Where
- Russia
- Volunteers
- 3 people
- Sponsor
- AstraZeneca
Neuromyelitis Optica Spectrum Disorders (NMOSD)
Modified Zipper Therapy for AQP4-IgG Positive Neuromyelitis Optica Spectrum Disorder
Study Title: A National, Multicenter, Randomized Controlled Trial of the Modified Zipper Therapy in AQP4 Antibody-Positive Neuromyelitis Optica Spectrum Disorder (ELITE Study) Brief Summary: The goal of this clinical trial is to…
- Trial name
- ELITE (NCT07420296)
- Testing
- Eculizumab administration, High-dose corticosteroid pulse therapy, Plasma exchange (PE)
- Where
- China
- Volunteers
- 198 people
- Sponsor
- Tianjin Medical University General Hospital
Neuromyelitis Optica, Neuromyelitis Optica Spectrum Disorder
Efficacy of Bevacizumab (Avastin) in Treatment of Acute NMO Exacerbations
This is a phase 1b interventional trial of bevacizumab (Avastin®) to evaluate the tolerability/safety and preliminary efficacy of bevacizumab (Avastin®) as add-on therapy for treatment of acute optic neuritis and/or transverse…
- Trial name
- NCT01777412
- Testing
- Bevacizumab
- Where
- United States
- Volunteers
- 10 people
- Sponsor
- Johns Hopkins University
Neuromyelitis Optica, Neuromyelitis Optica Spectrum Disorder
Safety and Efficacy of Daratumumab in Patients With Anti-Aquaporin 4 Antibody Positive Neuromyelitis Optica Spectrum Disorders
The objectives of this time-to-event study are to assess the efficacy and safety of Daratumumab as compared with placebo in participants with neuromyelitis optica spectrum disorder (NMOSD) who are anti-aquaporin-4 (AQP4)…
- Conditions
- Neuromyelitis Optica, Neuromyelitis Optica Spectrum Disorder, NMO Spectrum Disorder
- Trial name
- DAWN (NCT05403138)
- Testing
- Daratumumab
- Where
- China
- Volunteers
- 135 people
- Sponsor
- Tianjin Medical University General Hospital
Neuromyelitis Optica, NMO Spectrum Disorder
Pediatric NMOSD Observational Study
This study is being done to develop a database of pediatric patients in order to study the cause, early detection and best treatment for neuromyelitis optica spectrum disorder (NMOSD) in pediatric patients.
- Trial name
- NCT03766347
- Where
- United States
- Volunteers
- 100 people
- Sponsor
- Mayo Clinic
NMO Spectrum Disorder
Clinical Study of B001 Injection in Subjects With Neuromyelitis Optic Spectrum Disorder (NMOSD)
The objectives of this phase Ib study are to evaluate the efficacy, safety, pharmacokinetics, pharmacodynamics and immunogenic profiles of B001 in subjects with aquaporin-4 antibody (AQP4-IgG) positive NMOSD.
- Trial name
- NCT05145361
- Testing
- B001 injection
- Where
- 4 sites in China
- Volunteers
- 45 people
- Sponsor
- Shanghai Pharmaceuticals Holding Co., Ltd
Neuromyelitis Optica, Neuromyelitis Optica Spectrum Disorder
A Randomized Controlled Trial of Eculizumab in AQP4 Antibody-positive Participants With NMO (PREVENT Study)
The objectives of this time-to-event study were to assess the efficacy and safety of eculizumab as compared with placebo in participants with neuromyelitis optica spectrum disorder (NMOSD) who were anti-aquaporin-4 (AQP4)…
- Trial name
- NCT01892345
- Testing
- Eculizumab
- Where
- 70 sites in United States, Argentina and 16 more
- Volunteers
- 143 people
- Sponsor
- Alexion Pharmaceuticals, Inc.
Autoimmune Disease
The Safety and Efficacy of Universal CAR-T Cells Targeting BCMA in the Treatment of Refractory NMOSD
This is an open label, Multi-center，dose-escalation study in up to 18 participants with refractory NMOSD. This study aims to evaluate the safety and efficacy of universal CAR-T Cells targeting BCMA in the Treatment of refractory…
- Trial name
- NCT06633042
- Testing
- Universal BCMA-CD19 CART
- Volunteers
- 18 people
- Sponsor
- Bioray Laboratories