Clinical trials: NMO Spectrum Disorder (NMOSD)
Neuromyelitis Optica (NMO), NMO Spectrum Disorder (NMOSD)
Efficacy and Safety Study of Satralizumab (SA237) as Add-on Therapy to Treat Participants With Neuromyelitis Optica (NMO) and NMO Spectrum Disorder (NMOSD)
The objective of this study is to evaluate the efficacy, safety, pharmacodynamic, pharmacokinetic, and immunogenic profiles of satralizumab, compared with placebo, in addition to baseline immunosuppressive treatment in…
- Trial name
- NCT02028884
- Testing
- Satralizumab, Baseline Treatment
- Where
- 40 sites in United States, France and 9 more
- Volunteers
- 85 people
- Sponsor
- Hoffmann-La Roche
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
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
Myasthenia Gravis Generalised, Vaccination
Meningococcal Vaccination in Patients on Complement Inhibitors
Myasthenia gravis is an autoimmune neurological disorder caused by autoantibodies directed predominantly against components of the postsynaptic membrane of the neuromuscular junction.
- Conditions
- Myasthenia Gravis Generalised, Vaccination, Complement System, Neuromyelitis Optica Spectrum Disease (NMOSD)
- Trial name
- Vax_MenACWY (NCT06906692)
- Testing
- Serum Bactericidal Assay
- Where
- Italy
- Volunteers
- 35 people
- Sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Neuromyelitis Optica Spectrum Disorder Attack
Eculizumab For the Acute Attack of Neuromyelitis Optica Spectrum Disorder
Neuromyelitis optica spectrum disorder (NMOSD) is a relapsing, inflammatory autoimmune disorder of the central nervous system characterized by the pathogenic anti-aquaporin 4 antibody (AQP4-IgG).
- Trial name
- EASE-NMO (NCT07184840)
- Testing
- Intravenous Methylprednisolone (IVMP), Complement protein C5 inhibitor
- Where
- China
- Volunteers
- 110 people
- Sponsor
- Tianjin Medical University General Hospital
Neuromyelitis Optica Spectrum Disorder Attack
Safety and Efficacy Study of Sivelestat in Neuromyelitis Optica Spectrum Disorder
The primary objective of this study is to evaluate the safety and tolerability of sivelestat sodium hydrate administered in combination with standard steroid pulse therapy in patients experiencing an acute NMOSD attack.
- Trial name
- SIVAR-NMOSD (NCT07738952)
- Testing
- Sivelestat sodium hydrate
- Where
- Japan
- Volunteers
- 7 people
- Sponsor
- Kyushu University
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.
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 Disorder
A Study to Evaluate the Safety and Efficacy of Satralizumab in Participants With Neuromyelitis Optica Spectrum Disorder (NMOSD)
This multicenter, single-arm, open-label study will evaluate the long-term safety and efficacy of satralizumab in participants with neuromyelitis optica spectrum disorder (NMOSD) who completed open-label extension (OLE) period of…
- Trial name
- NCT04660539
- Testing
- satralizumab, azathioprine (AZA), mycophenolate mofetil (MMF)
- Where
- 53 sites in United States, Bulgaria and 16 more
- Volunteers
- 119 people
- Sponsor
- Hoffmann-La Roche
Neuromyelitis Optica Spectrum Disorder (NMOSD)
A Study to Evaluate IMC-002 in Neuromyelitis Optica Spectrum Disorder (NMOSD) Patients
The purpose of this study is to evaluate the efficacy and safety of IMC-002 in the treatment of NMOSD.
- Trial name
- NCT06557174
- Testing
- IMC-002, mycophenolate mofetil， MMF
- Volunteers
- 116 people
- Sponsor
- ImmuneCare Biopharmaceuticals (Shanghai) Co., Ltd.
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
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 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 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
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 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
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 Disease (NMOSD), Ripertamab
Study on Efficacy Evaluation of Ripertamab in the Treatment of Neuromyelitis Optica Spectrum Disorders
This clinical trial aims to evaluate the safety and efficacy of ripertamab in patients with neuromyelitis optica spectrum disorders (NMOSD). The key research objectives are as follows: 1.
- Trial name
- RIPERT-NMOSD (NCT07685678)
- Testing
- Ripertamab
- Volunteers
- 20 people
- Sponsor
- Zhongming Qiu
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.