Clinical trials: Neuromyelitis Optica Spectrum Disorder (NMOSD)
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
Neuromyelitis Optica Spectrum Disorders (NMOSD)
HANDLE-a Real World Study on Satralizumab in NMOSD
This study is a single-center, retrospective-prospective, non-interventional cohort study to assess the clinical outcomes of Chinese NMOSD patients treated with satralizumab in a real-world patient management model by collecting…
- Trial name
- NCT06829524
- Testing
- Satralizumab
- Where
- China
- Volunteers
- 100 people
- Sponsor
- Huashan Hospital
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 (NMOSD)
Efficacy and Safety of Low-Dose IL-2 in Neuromyelitis Optica Spectrum Disorder
Interleukin-2 (IL-2) is an essential cytokine for T-cell proliferation. Low-dose IL-2 has been shown to increase the proportion of regulatory T cells (Tregs), negatively regulate effector T cells such as Th17 and Tfh cells, and…
- Trial name
- NCT07809724
- Testing
- IL-2 (interleukin 2)
- Where
- China
- Volunteers
- 60 people
- Sponsor
- Peking University People's Hospital
Neuromyelitis Optica Spectrum Disorders (NMOSD)
A Multicenter Prospective Real-World Effectiveness and Safety of Satralizumab in the Early Treatment of Attacks in NMOSD
This study is a multicenter, prospective cohort study designed to enroll 50 NMOSD patients who receive Satralizumab treatment during the early phase of an NMOSD attack.
- Trial name
- SATURN (NCT07762872)
- Testing
- Satralizumab
- Where
- China
- Volunteers
- 50 people
- Sponsor
- Junwei Hao, MD
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), Neuropathic Pain
Crisugabalin in NMOSD Neuropathic Pain: A Randomized, Double-Blind, Placebo-Controlled Exploratory Trial
This study is a multicenter, prospective, randomized, double-blind, placebo-controlled exploratory investigation conducted in China.
- Trial name
- TERMINATOR (NCT07699770)
- Testing
- Crisugabalin
- Where
- 10 sites in China
- Volunteers
- 110 people
- Sponsor
- Tang-Du Hospital
Multiple Sclerosis (MS), Neuromyelitis Optica Spectrum Disease (NMOSD)
A Study of LCAR-AIO CAR-T Cells for Treating Relapsed/Refractory Neurological Autoimmune Diseases
This is a prospective, single-arm, open-label, dose-exploration and expansion clinical study of LCAR-AIO in adult subjects with relapsed/refractory neurological autoimmune diseases.
- Conditions
- Multiple Sclerosis (MS), Neuromyelitis Optica Spectrum Disease (NMOSD), Anti-Myelin Oligodendrocyte Glycoprotein-IgG Associated Disorders (MOGAD), Myasthenia Gravis
- Trial name
- NCT06869278
- Testing
- LCAR-AIO T cells
- Where
- 3 sites in China
- Sponsor
- Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Neuromyelitis Optica Spectrum Disorders (NMOSD), Multiple Sclerosis
Cohort Study on Neuroimmune Diseases in the Reproductive Age
Neuroimmune diseases are more prevalent among women of reproductive age. Studies have shown that neuroimmune diseases may impact fertility.
- Conditions
- Neuromyelitis Optica Spectrum Disorders (NMOSD), Multiple Sclerosis, Autoimmune Encephalitis, Myasthenia Gravis
- Trial name
- RANID (NCT07653984)
- Where
- China
- Volunteers
- 100 people, healthy volunteers welcome
- Sponsor
- Third Affiliated Hospital, Sun Yat-Sen University
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
Multiple Sclerosis (MS), Neuromyelitis Optica Spectrum Disorder (NMOSD)
Safety and Pharmacodynamics of QH103 Cell Injection in the Treatment of Patients With Relapsed/Refractory Antibody-Mediated Neurological Autoimmune Diseases.
This study is an open-label, exploratory, prospective clinical trial with dose escalation(according to "3+3" design), to evaluate the safety and tolerability of QH103(Universal CD19 CAR-γδT Cell Injection)in the treatment of…
- Conditions
- Multiple Sclerosis (MS), Neuromyelitis Optica Spectrum Disorder (NMOSD), Autoimmune Encephalitis (AE), Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)
- Trial name
- NCT07526493
- Testing
- Universal CD19 CAR-γδT Cell Injection, Cyclophosphamide, Fludarabine
- Where
- China
- Volunteers
- 6 people
- Sponsor
- Tongji Hospital
Systemic Sclerosis (SSc), Idiopathic Inflammatory Myopathy (IIM)
Phase 1 Study of HBI0101 CAR-T in Refractory B-Cell Autoimmune Diseases
A Phase 1 study of HBI0101 BCMA-CART in B-Cell Mediated Autoimmune Rheumatic Diseases. The goal of the study is evaluation of safety and identification of the maximum HBI0101 CART dose that may be administered safely to patients…
- Conditions
- Systemic Sclerosis (SSc), Idiopathic Inflammatory Myopathy (IIM), Rheumatoid Arthritis (RA), Systemic Lupus Erythematosus (SLE)
- Trial name
- NCT07085676
- Testing
- HBI0101 CART
- Where
- Israel
- Volunteers
- 120 people
- Sponsor
- Polina Stepensky
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.
Multiple Sclerosis (MS), Neuromyelitis Optica Spectrum Disorders (NMOSD)
A Study of C-CAR168 in the Treatment of Central Nervous System Autoimmune Diseases Refractory to Standard Therapy
This is an investigator-initiated, single-center, open-label study of C-CAR168, an autologous bi-specific CAR-T therapy targeting CD20 and BCMA, for the treatment of adult patients with central nervous system autoimmune diseases…
- Conditions
- Multiple Sclerosis (MS), Neuromyelitis Optica Spectrum Disorders (NMOSD), Autoimmune Encephalitis, Stiff Person Syndrome
- Trial name
- NCT07341828
- Testing
- CD20/BCMA-directed CAR-T cells
- Volunteers
- 15 people
- Sponsor
- Huashan Hospital
MS (Multiple Sclerosis), NMO Spectrum Disorder (NMOSD)
Multiple Sclerosis Versus Neuromyelitis Optica Spectrum Disorder
The aim of this work is to do a detailed comparison between multiple sclerosis and Neuromyelitis Optica Spectrum Disorder due to delicate similarities between both diseases and wide rang of management and follow up of the patients
- Trial name
- NCT07304960
- Volunteers
- 100 people
- Sponsor
- Assiut University
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 (NMO), Neuromyelitis Optica Spectrum Disorders (NMOSD)
Slow vs. Rapid Glucocorticoids Tapering With Inebilizumab in NMOSD
Neuromyelitis optica spectrum disorder (NMOSD) is a central nervous system autoimmune condition mainly involving the spinal cord, optic nerves, and area postrema.
- Trial name
- STARGlu-NMO (NCT07132398)
- Testing
- Slow-tapering glucocorticoids + Inebilizumab, Rapid-tapering glucocorticoids + Inebilizumab
- Volunteers
- 170 people
- Sponsor
- Tianjin Medical University General Hospital
Systemic Lupus Erythematosus (SLE), Immune-mediated Necrotizing Myopathy (IMNM)
A Study of C-CAR168 in the Treatment of Autoimmune Diseases Refractory to Standard Therapy
This is an investigator-initiated, multicenter, open-label study of C-CAR168, an autologous bi-specific CAR-T therapy targeting CD20 and BCMA, for the treatment of adult patients with autoimmune diseases refractory to standard…
- Conditions
- Systemic Lupus Erythematosus (SLE), Immune-mediated Necrotizing Myopathy (IMNM), Neuromyelitis Optica Spectrum Disorders (NMOSD), Multiple Sclerosis (MS)
- Trial name
- CAR-AID (NCT06249438)
- Testing
- CD20/BCMA-directed CAR-T cells
- Where
- China
- Volunteers
- 30 people
- Sponsor
- RenJi Hospital
Neuromyelitis Optica Spectrum Disorder (NMOSD)
Efficacy and Safety of Conventional Immunosuppressant Therapies in Elderly Patients With Neuromyelitis Optica Spectrum Disorder
Newly diagnosed NMOSD patients
- Trial name
- NCT07032337
- Volunteers
- 2,985 people
- Sponsor
- Samsung Medical Center