RecruitingPhase 1Phase 2NCT05504694

Ofatumumab in AQP4-IgG Seropositive NMOSD

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


Sponsor

Tang-Du Hospital

Enrollment

5 participants

Start Date

Jun 28, 2022

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests a medication called ofatumumab for treating neuromyelitis optica spectrum disorder (NMOSD) — a rare autoimmune disease that attacks the optic nerves and spinal cord. NMOSD can cause episodes of vision loss and paralysis. This trial aims to see if ofatumumab can reduce these attacks. You may be eligible if: - You are 18 or older - You have been diagnosed with NMOSD with a positive AQP4-IgG antibody test - You have had at least 2 relapses in the past 24 months, with at least 1 in the past 12 months - Your disability score (EDSS) is between 0 and 7.5 - You are willing to use effective contraception if you have childbearing potential You may NOT be eligible if: - You are pregnant, breastfeeding, or planning to become pregnant - You have an active or recent serious infection (including hepatitis B or C, or tuberculosis) - You have had cancer in the past 5 years - You have had a recent live vaccine (within 6 weeks) - You are participating in another clinical trial - You have had your spleen removed Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGOfatumumab

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.


Locations(1)

Tangdu Hospital

Xi'an, Shaanxi, China

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NCT05504694


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