Ofatumumab in AQP4-IgG Seropositive NMOSD

NCT05504694 | Recruiting Phase 1

• 1 other identifier: K202206-13
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Neuromyelitis Optica Spectrum Disorder

Keywords

Neuromyelitis Optica Spectrum Disorder; Aquaporin 4; Ofatumumab

Outcome Measures

Primary Outcomes (1)

• Change from baseline in annual relapse rate (ARR) at last follow-up visit

  Pre-treatment ARR was determined at baseline by the total number of attacks divided by disease course from onset to baseline; post-treatment ARR is determined at 12 months after treatment by the number of relapses divided by 12 months.

  baseline, 12 months

Secondary Outcomes (8)

• Change from baseline in Expanded Disability Status Scale (EDSS) score

  baseline, 3 months, 6 months, 9 months, 12 months

• Change from baseline in lesion burden on MRI T2-weighted images

  baseline, 6 months, 12 months

• Change from baseline in optic coherence tomography (OCT) measures

  baseline, 6 months, 12 months

• Change from baseline in the frequencies of circulating B cell subsets

  baseline, 1 week, 2 weeks, 1 month, 3 months, 6 months, 9 months, 12 months

• Change from baseline in immune landscape

  baseline, 1 week, 2 weeks, 1 month, 3 months, 6 months, 9 months, 12 months

Study Arms (1)

Ofatumumab

EXPERIMENTAL

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.

Drug: Ofatumumab

Interventions

Ofatumumab DRUG

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.

Also known as: Arzerra

Ofatumumab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tang-Du Hospital: lead
• Henan Provincial People's Hospital: collaborator

Study Sites (1)

Tangdu Hospital

Xi'an, Shaanxi, China

RECRUITING

MeSH Terms

Conditions

Neuromyelitis Optica

Interventions

ofatumumab

Condition Hierarchy (Ancestors)

Myelitis, Transverse; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Optic Neuritis; Optic Nerve Diseases; Cranial Nerve Diseases; Demyelinating Diseases; Eye Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Jun Guo, M.D.

  Tang-Du Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jun Guo, M.D.

CONTACT

86-29-8477 8844; guojun_81@163.com

Yan Jia, M.S.

CONTACT

86-29-8471 7483; neurologist_jiayan@163.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Department of Neurology

Study Record Dates

• First Submitted: August 16, 2022
• First Posted: August 17, 2022
• Study Start: June 28, 2022
• Primary Completion (Estimated): April 30, 2026
• Study Completion (Estimated): July 31, 2026
• Last Updated: January 30, 2026

Record last verified: 2026-01

Locations

CN (1)