Protein A immuNoaDsorption for the Treatment of Acute Episodes of Neuromyelitis Optica Spectrum Disorder

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

144 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-04-25

Study Completion Date

2026-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

To clarify the efficacy and safety of protein A immunoadsorption therapy for acute exacerbations of neuromyelitis optica spectrum disorders(NMOSD), we designed a multicenter, open-label, superiority randomized controlled clinical trial, planning to enroll 144 patients with NMOSD. We plan to treat patients with acute NMOSD using protein A immunoadsorption combined with high-dose intravenous methylprednisolone, and compare this with treatment using high-dose intravenous methylprednisolone alone. The aim is to observe the impact and safety of protein A immunoadsorption on the treatment efficacy for these patients experiencing acute exacerbations of NMOSD, ultimately providing more comprehensive clinical evidence to support treatment protocols for the acute phase of NMOSD.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Comparison of the Efficacy and Safety of Immunoadsorption and Plasma Exchange for Acute Attack of Refractory Neuromyelitis Optica Spectrum Disorders

NCT04064944

Neuromyelitis Optica Spectrum Disorder

UNKNOWN PHASE2

Efficacy, Safety, PK, PD, and ADA of Eculizumab in Chinese Adults With NMOSD

NCT06724809

NMOSD Neuromyelitis Optica Spectrum Disorders

ACTIVE_NOT_RECRUITING PHASE3

Tocilizumab vs Azathioprine in Neuromyelitis Optica Spectrum Disorders

NCT03350633

Neuromyelitis Optica Spectrum Disorders Neuromyelitis Optica

COMPLETED PHASE2/PHASE3

Inectolizumab With Steroid Optimization in Newly Treated NMOSD

NCT07159893

Neuromyelitis Optica Autoimmune Diseases Demyelinating Autoimmune Diseases, CNS

NOT_YET_RECRUITING NA

Eculizumab For the Acute Attack of Neuromyelitis Optica Spectrum Disorder

NCT07184840

Neuromyelitis Optica Spectrum Disorder Attack

RECRUITING PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Neuromyelitis Optica Spectrum Disorders

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

experimental group

The experimental group was treated with a combination of protein A immunoadsorption and intravenous methylprednisolone. The methylprednisolone was administered following a regimen of 1g for 5 days, 0.5g for 3 days, 0.25g for 2 days, and 0.12g for 1 day. Protein A immunoadsorption was conducted every other day, unless a physician determined that the patient's condition was unsuitable for treatment, in which case treatment was administered according to medical advice. A total of 5 treatments were given, with each session involving the regeneration of plasma at 1 to 3 times the plasma volume. Sequentially, the patients in this group were uniformly administered oral immunosuppressants, specifically azathioprine or mycophenolate mofetil (MMF).

Group Type EXPERIMENTAL

Protein A immunoadsorption

Intervention Type DEVICE

The experimental group was treated with a combination of protein A immunoadsorption and intravenous methylprednisolone. The methylprednisolone was administered following a regimen of 1g for 5 days, 0.5g for 3 days, 0.25g for 2 days, and 0.12g for 1 day. Protein A immunoadsorption was conducted every other day, unless a physician determined that the patient's condition was unsuitable for treatment, in which case treatment was administered according to medical advice. A total of 5 treatments were given, with each session involving the regeneration of plasma at 1 to 3 times the plasma volume.

control group

The control group was treated with intravenous methylprednisolone, following a regimen of 1g for 5 days, 0.5g for 3 days, 0.25g for 2 days, and 0.12g for 1 day.Sequentially, the patients in this group were uniformly administered oral immunosuppressants, specifically azathioprine or mycophenolate mofetil (MMF).

Group Type ACTIVE_COMPARATOR

intravenous methylprednisolone

Intervention Type DRUG

The control group was treated with intravenous methylprednisolone, following a regimen of 1g for 5 days, 0.5g for 3 days, 0.25g for 2 days, and 0.12g for 1 day.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Protein A immunoadsorption

The experimental group was treated with a combination of protein A immunoadsorption and intravenous methylprednisolone. The methylprednisolone was administered following a regimen of 1g for 5 days, 0.5g for 3 days, 0.25g for 2 days, and 0.12g for 1 day. Protein A immunoadsorption was conducted every other day, unless a physician determined that the patient's condition was unsuitable for treatment, in which case treatment was administered according to medical advice. A total of 5 treatments were given, with each session involving the regeneration of plasma at 1 to 3 times the plasma volume.

Intervention Type DEVICE

intravenous methylprednisolone

The control group was treated with intravenous methylprednisolone, following a regimen of 1g for 5 days, 0.5g for 3 days, 0.25g for 2 days, and 0.12g for 1 day.

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

1. clinical diagnosis of acute Neuromyelitis Optica Spectrum Disorders (NMOSD)
2. Age and Gender: Participants must be between 18 and 65 years old, inclusive, with no gender restrictions.
3. Serological Marker: Participants must test positive for AQP4-IgG using the cell-based assay (CBA) method.
4. Understanding and Consent: Participants or their legal representatives must be able to understand the study's purpose, demonstrate sufficient compliance with the study protocol, and sign the informed consent form.

Exclusion Criteria

1. Women who are pregnant or breastfeeding.
2. Participants who cannot establish peripheral or central venous access, or have a history of allergic reactions to plasmapheresis.
3. Participants with contraindications to intravenous methylprednisolone treatment.
4. Participants who have used monoclonal antibodies in the last 6 months, or FcRn antagonists in the last 3 months.
5. Participants who must use ACE inhibitors (ACEI) within 1 week before the start of treatment or during the study, and cannot discontinue their use.
6. Severe Bleeding or Bleeding Disorders
7. Severe Heart Failure
8. Severe Infections

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No