Clinical trials: Neuromyelitis Optica Spectrum Disorders
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
NMO Spectrum Disorder, MRI
Clinical and Imaging Cohort of Neuroinflammation Diseases in China (CLUE)
CLUE is a prospective study to assess structural and functional changes of the brain, spinal cord, and optic nerve, as well as the inflammatory environment in patients with neuroinflammatory and demyelinating diseases.
- Conditions
- NMO Spectrum Disorder, MRI, Multiple Sclerosis, MOGAD
- Trial name
- NCT04106830
- Testing
- Intravenous steroid
- Where
- China
- Volunteers
- 1,000 people, healthy volunteers welcome
- Sponsor
- Beijing Tiantan Hospital
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 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 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
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.
Neuromyelitis Optica Spectrum Disorders
Anticipating Irreversible Disability in Neuromyelitis Optica Spectrum Disorder: a Study to Assess Disease Activity in Apparently Stable Patients
The present research is an observational clinical study. The project aims to investigate astrocytic damage, assessed through biological findings such as an increase in GFAP level and/or MRI water index, in patients with NMOSD and…
- Trial name
- NCT07526298
- Testing
- MRI, Immunological Factors
- Where
- Italy
- Volunteers
- 50 people
- Sponsor
- IRCCS San Raffaele
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 Disorders, Multiple Sclerosis
Universal Chimeric Antigen Receptor T-Cell （UCAR T-cell） Therapy Targeting CD19/ BCMA（QT-019C） in Patients With r/ r Neurological Autoimmune Diseases
This is an open label, single-site, dose-escalation study in up to 15 participants with relapsed or refractory Neurological Autoimmune Diseases.
- Conditions
- Neuromyelitis Optica Spectrum Disorders, Multiple Sclerosis, Myasthenia Gravis
- Trial name
- NCT07392528
- Testing
- QT-019C
- Where
- China
- Volunteers
- 15 people
- Sponsor
- Tianjin Huanhu Hospital
Neuromyelitis Optica Spectrum Disorder
CorEvitas SPHERES (Synergy of Prospective Health & Experimental Research for Emerging Solutions) Registry for Neuromyelitis Optica Spectrum Disorder (NMOSD)
This is a Prospective, observational research study for patients with NMOSD under the care of a licensed neurologist. Approximately 800 patients and 35 clinical sites in North America will be recruited to participate with no…
- Trial name
- NCT04886492
- Where
- United States
- Volunteers
- 800 people
- Sponsor
- CorEvitas
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.
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
NMO Spectrum Disorder
Efficacy and Safety of Transcranial Temporal Interference Stimulation (tTIS) for Neuropathic Pain in Neuromyelitis Optica Spectrum Disorder (NMOSD)
This is an open-label, single-arm, single-center prospective pilot study to assess the efficacy and safety of transcranial temperol interference stimulation in patients with neuromyelitis optica spectrum disorder (NMOSD)…
- Trial name
- NCT07377305
- Testing
- 10Hz tTIS (2-4mA) Intervention
- Where
- China
- Volunteers
- 12 people
- Sponsor
- Tang-Du Hospital
Multiple Sclerosis, NMO Spectrum Disorder
Tongji NADs Cohort
Neurological Autoimmune Diseases (NADs) are disorders caused by abnormal immune system attacks on neural tissues, affecting multiple systems including the central nervous system, peripheral nervous system, and neuromuscular…
- Conditions
- Multiple Sclerosis, NMO Spectrum Disorder, Autoimmune Encephalitis, Myelin Oligodendrocyte Glycoprotein Antibody-associated Disease
- Trial name
- NCT07333196
- Testing
- No active interventions
- Where
- China
- Volunteers
- 1,550 people
- Sponsor
- Tongji 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