NCT05356858

An Open Label Study of the Effects and Safety of Zanubrutinib in NMOSDs Adult Patients

An Open Label Trial Evaluating the Efficacy and Safety of Bruton's Tyrosine Kinase (BTK) Inhibitor Zanubrutinib in Adult Patients With Neuromyelitis Optical Spectrum Disorders (NMOSDs)

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Xuanwu Hospital, Beijing · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This is an open-label study, to evaluate the efficacy and safety of a BTK inhibitor zanubrutinib in participants with NMOSDs.

Detailed description

This is an open, single-center clinical study to evaluate the efficacy and safety of Zanubrutinib in the treatment of recurrent neuromyelitis optica spectrum disease. Patients were required to be diagnosed with neuromyelitis optic spectrum disease according to the NMOSD diagnostic criteria established by the international NMO Diagnostic Group (IPND) in 2015, and to have had at least two relapses (including first episode) within two years while at least one relapse occurring within the 12 months prior to screening. The AQP4 antibody must be positive during screening.

Conditions

• Neuromyelitis Optica

Interventions

Type	Name	Description
DRUG	zanubrutinib	zanubrutinib orally, 80mg bid for 1 year

Timeline

• Start date: 2022-05-07
• Primary completion: 2024-10-01
• Completion: 2024-10-01
• First posted: 2022-05-02
• Last updated: 2022-05-20

Locations

1 site across 1 country: China