Clinical trials: Neuromyelitis Optica Spectrum Disorders
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, 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
NMOSD, Neuromyelitis Optica Spectrum Disorder
Efficacy, Safety, Pharmacokinetics, Pharmacodynamics, and Immunogenicity Study of Ravulizumab in Chinese Adults With Neuromyelitis Optica Spectrum Disorder (NMOSD)
The primary objective of this study is to confirm the efficacy, safety, pharmacokinetics (PK), pharmacodynamics (PD), and immunogenicity of ravulizumab in the treatment of Chinese adults with anti-aquaporin-4 (AQP4) antibody (Ab)…
- Trial name
- NCT07557420
- Testing
- Ravulizumab
- Where
- 10 sites in China
- Volunteers
- 19 people
- Sponsor
- Alexion Pharmaceuticals, Inc.
Neuromyelitis Optica Spectrum Disorder, Pregnancy Related
Observational Safety Study in Women With Neuromyelitis Optica Spectrum Disorder (NMOSD) Exposed to UPLIZNA® During Pregnancy
This is an observational study to monitor female participants exposed to UPLIZNA during pregnancy. This study requires voluntary reporting of pregnancies in female participants with NMOSD exposed to UPLIZNA during pregnancy or…
- Trial name
- NCT05909761
- Testing
- UPLIZNA
- Where
- United States
- Volunteers
- 60 people
- Sponsor
- Amgen
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 Disorder
Acceptability and Safety of MR-C-014 in Persons With Neuromyelitis Optica Spectrum Disorder
The purpose of this proof of concept study is to assess the acceptability and safety of MR-C-014 in persons with Neuromyelitis optica spectrum disorder (NMOSD) who have a gait deficit.
- Trial name
- aNiMatO (NCT06374264)
- Testing
- MR-C-014
- Where
- 2 sites in United States
- Volunteers
- 30 people
- Sponsor
- MedRhythms, Inc.
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.
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.
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 Spectrum Disorders
A Clinical Study of B001 Injection in the Treatment of Neuromyelitis Optica Spectrum Disorders(NMOSD)
To evaluate the efficacy and safety of B001 injection in aquaporin-4 antibody positive patients with neuromyelitis optica spectrum disorder.
- Trial name
- NCT06413654
- Testing
- B001
- Where
- 51 sites in China
- Volunteers
- 132 people
- Sponsor
- Shanghai Jiaolian Drug Research and Development Co., Ltd
Ultomiris-exposed Pregnant/ Postpartum, Pregnancy
Study of Ultomiris® (Ravulizumab) Safety in Pregnancy
The primary objective of this study is to describe the frequency and characteristics of pregnancy outcomes and maternal complications among participants exposed to Ultomiris and to describe the frequency and characteristics of…
- Conditions
- Ultomiris-exposed Pregnant/ Postpartum, Pregnancy, Paroxysmal Nocturnal Hemoglobinuria (PNH), Atypical Hemolytic Uremic Syndrome (aHUS)
- Trial name
- NCT06312644
- Testing
- Ultomiris
- Where
- 7 sites in United States, Australia and 5 more
- Volunteers
- 75 people
- Sponsor
- Alexion Pharmaceuticals, Inc.
Neuromyelitis Optica Spectrum Disorders
A Phase III Study of TACI-antibody Fusion Protein Injection (RC18) in Subjects With Neuromyelitis Optica Spectrum Disorders
The purpose of this study is to initially observe the safety and effectivity of RC18 in Participants with Neuromyelitis Optica Spectrum Disorders.
- Trial name
- NCT03330418
- Testing
- RC18 160 mg
- Where
- China
- Volunteers
- 178 people
- Sponsor
- RemeGen Co., Ltd.
SLE, Sclerosis
A Study of RD06-04 in Patients With Active Autoimmune Diseases
This is an open-label, Phase I, investigator-initiated trial (IIT) aimed at evaluating the safety, tolerability, pharmacokinetics, pharmacodynamics, and efficacy of RD06-04 in patients with autoimmune diseases mediated by…
- Conditions
- SLE, Sclerosis, ANCA Associated Vasculitis, IIM
- Trial name
- NCT06548620
- Testing
- RD06-04 cell infusion
- Where
- China
- Sponsor
- Nanjing Bioheng Biotech Co., Ltd.
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.
Multiple Sclerosis, NMO Spectrum Disorder
Clinical Impact Through AI-assisted MS Care - A Retrospective Multi-center Observational Study.
The RECLAIM study aims to gather a centralized and harmonized dataset, enabling the secondary use of data for building AI-based models that will support diagnosis and prognosis of individual Multiple Sclerosis patient's disease…
- Conditions
- Multiple Sclerosis, NMO Spectrum Disorder, Myelin Oligodendrocyte Glycoprotein Antibody-associated Disease, Radiologically Isolated Syndrome
- Trial name
- RECLAIM (NCT06280755)
- Where
- 3 sites in Czechia, Germany
- Volunteers
- 7,000 people, healthy volunteers welcome
- Sponsor
- icometrix
Neuromyelitis Optica Spectrum Disorder
Study of Inebilizumab in Pediatric Subjects With Neuromyelitis Optica Spectrum Disorder
A Phase 2, open-label, multicenter study to evaluate the pharmacokinetics (PK), pharmacodynamics (PD), and safety of inebilizumab in eligible pediatric participants 2 to < 18 years of age with recently active neuromyelitis optica…
- Trial name
- NCT05549258
- Testing
- Inebilizumab
- Where
- 19 sites in United States, Argentina and 9 more
- Volunteers
- 15 people
- Sponsor
- Amgen
Neuromyelitis Optica Spectrum Disorder
Long-term, Open-label, Safety Study of Inebilizumab in Neuromyelitis Optica Spectrum Disorder (NMOSD)
The purpose of this study is to understand the effects of long-term treatment with inebilizumab on circulating levels of immunoglobulins, B-cell counts, and other safety measures, and to further monitor repletion of immunoglobins…
- Trial name
- N-MOmentum LT (NCT06180278)
- Testing
- Blood tests, Inebilizumab
- Where
- 11 sites in United States, China and 5 more
- Volunteers
- 32 people
- Sponsor
- Amgen
Neuromyelitis Optica, Neuromyelitis Optica Spectrum Disorder
An Efficacy and Safety Study of Ravulizumab in Adult Participants With NMOSD
The primary purpose of this study is to evaluate the efficacy and safety of ravulizumab for the treatment of adult participants with NMOSD.
- Trial name
- NCT04201262
- Testing
- Ravulizumab
- Where
- 41 sites in United States, Australia and 11 more
- Volunteers
- 58 people
- Sponsor
- Alexion Pharmaceuticals, Inc.
Neuromyelitis Optica Spectrum Disorder
A Study of MIL62 in Patients With Neuromyelitis Optica Spectrum Disorder (NMOSD)
This study will evaluate the safety and efficacy of MIL62 in patients with Neuromyelitis Optica Spectrum Disorder.
- Trial name
- NCT05314010
- Testing
- MIL62
- Where
- China
- Volunteers
- 102 people
- Sponsor
- Beijing Mabworks Biotech Co., Ltd.
Neuromyelitis Optica Spectrum Disorders
A Phase I Clinical Trial of BAT4406F Injection in Patients With Neuromyelitis Optica Spectrum Disorders
This study is a phase I clinical study of the safety, tolerability, and pharmacokinetics of BAT4406F injection in patients with neuromyelitis optica spectrum disorders.
- Trial name
- NCT04146285
- Testing
- BAT4406F
- Where
- China
- Volunteers
- 15 people
- Sponsor
- Bio-Thera Solutions