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Ofatumumab in AQP4-IgG Seropositive NMOSD

T

Tang-Du Hospital

Status and phase

Enrolling
Phase 2
Phase 1

Conditions

Neuromyelitis Optica Spectrum Disorder

Treatments

Drug: Ofatumumab

Study type

Interventional

Funder types

Other

Identifiers

NCT05504694
K202206-13

Details and patient eligibility

About

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.

Full 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.

Enrollment

5 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

5 participants in 1 patient group

Ofatumumab
Experimental group
Description:
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.
Treatment:
Drug: Ofatumumab

Trial contacts and locations

1

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Central trial contact

Yan Jia, M.S.; Jun Guo, M.D.

Data sourced from clinicaltrials.gov

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