Overview

Ofatumumab in AQP4-IgG Seropositive NMOSD

Status:
Recruiting
Trial end date:
2024-12-01
Target enrollment:
0
Participant gender:
All
Summary
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.
Phase:
Phase 1/Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Tang-Du Hospital
Collaborator:
Henan Provincial People's Hospital
Treatments:
Ofatumumab
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.