Menu
Recruiting NCT05504694

Ofatumumab in AQP4-IgG Seropositive NMOSD

Phase I / Phase II Interventional Neuromyelitis Optica Spectrum Disorder

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Ofatumumab.
Who it may be relevant to
Registry conditions: Neuromyelitis Optica Spectrum Disorder. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Efficacy and Safety of Ofatumumab in AQP4-IgG Seropositive NMOSD: an Open-label, Single-arm, Multicentre Prospective Pilot Study

Overview

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.

Detailed description

Neuromyelitis optica spectrum disorder (NMOSD) is a rare but severe demyelinating disorder that affects mainly adult patients. It is associated with a pathological B cell-mediated humoral immune response against the aquaporin-4 (AQP4) water channel. Monoclonal antibodies against CD20 have been shown to be effective for prevention of relapses in patients with NMOSD, and therefore been recommended as first-line therapy for this disorder. Ofatumumab (OFA), a fully humanized anti-CD20 monoclonal antibody, has been approved for multiple sclerosis treatment. However, prospective multicenter studies are needed to determine the efficacy and safety of ofatumumab in treating NMOSD.

Interventions

  • Drug Ofatumumab
    The enrolled patients will receive ofatumumab (20 mg/0.4 ml) subcutaneously administered at baseline, Day 7, Day 14 and monthly thereafter. Patients will receive ofatumumab therapy for a total of 48 weeks. The first 4 infusions will be administered at study center site; subsequent infusions will be given in the patient's home with a nurse online interview to administer the infusion.

Primary outcome measures

  • Change from baseline in annual relapse rate (ARR) at last follow-up visit [Time frame: baseline, 12 months]
Secondary outcome measures (8)
  • Change from baseline in Expanded Disability Status Scale (EDSS) score [Time frame: baseline, 3 months, 6 months, 9 months, 12 months]
  • Change from baseline in lesion burden on MRI T2-weighted images [Time frame: baseline, 6 months, 12 months]
  • Change from baseline in optic coherence tomography (OCT) measures [Time frame: baseline, 6 months, 12 months]
  • Change from baseline in the frequencies of circulating B cell subsets [Time frame: baseline, 1 week, 2 weeks, 1 month, 3 months, 6 months, 9 months, 12 months]
  • Change from baseline in immune landscape [Time frame: baseline, 1 week, 2 weeks, 1 month, 3 months, 6 months, 9 months, 12 months]
  • Biochemical indicators monitoring [Time frame: baseline, 1 month, 3 months, 6 months, 9 months, 12 months]
  • Assessment of functional questionnaire [Time frame: baseline, 1 month, 3 months, 6 months, 9 months, 12 months]
  • Adverse events [Time frame: 1 week, 2 weeks, 1 month, 3 months, 6 months, 9 months, 12 months]

Eligibility criteria

Inclusion criteria

  • Diagnosis of NMOSD according to the 2015 International Panel Diagnostic Criteria for NMOSD with AQP4-IgG.
  • Clinical evidence of at least 2 relapses (including first attack) in past 24 months with at least 1 relapse occurring in the preceding 12 months.
  • Adults aged ≥18 years old.
  • Expanded disability status scale (EDSS) score between 0 and 7.5 (inclusive).
  • Provision of written informed consent to participate in this study.
  • Only oral corticosteroids were permitted at screening (≤10mg equivalent per day), which should be terminated within one month.
  • Effective contraception was used for female patients with fertility during the treatment or at least 3 months after stopping medication.

Exclusion criteria

  • Progressive neurological deterioration unrelated to relapses of NMOSD, or presence of neurological findings suspected with PML.
  • Pregnant or breastfeeding patients and those with family planning during the study period.
  • Patients participating in any other clinical therapeutic study at the screening or within 30 days of screening.
  • Patients with splenectomy or history of no spleen, and those with planned surgery (excluding minor surgery) during the study period.
  • Presence of uncontrolled severe concurrent diseases; long-term glucocorticoids or immunosuppressants use due to other autoimmune diseases, or presence of other chronic diseases that cannot receiving immunosuppression.
  • Active infection at within 4 weeks before baseline.
  • Positive for HBV or HCV.
  • Evidence of latent or active tuberculosis (TB).
  • Have received any live or live-attenuated vaccine within 6 weeks before baseline.
  • History of malignancy in past 5 years, including solid tumor, malignant hematopathy and carcinoma in situ.
  • History of severe allergic reactions to biological agents.
  • Inability to provide written informed consent.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

China · 1 center
  • Tangdu Hospital — Xi'an

Identifiers

NCT: NCT05504694 · K202206-13

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗