deltatrials
Terminated INTERVENTIONAL 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)

Sponsor: Xuanwu Hospital, Beijing

Interventions zanubrutinib
Updated 5 times since 2022 Last updated: Apr 21, 2026 Started: May 7, 2022 Primary completion: Feb 24, 2024 Completion: Feb 24, 2024
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

Terminated

Difficult in participant recruiting

A observational or N/A phase clinical study on Neuromyelitis Optica, this trial is terminated or withdrawn. The trial is conducted by Xuanwu Hospital, Beijing and has accumulated 5 data snapshots since 2022. Longitudinal tracking of this trial contributes to a broader understanding of treatment development timelines.

Study Description(click to expand)

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.

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.

Status Flow

~Jun 2022 – ~Jul 2024 · 25 months · monthly snapshotRecruiting~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshot~Sep 2024 – ~Nov 2024 · 2 months · monthly snapshot~Nov 2024 – ~Apr 2026 · 18 months · monthly snapshotUnknownApr 28, 2026 – present · 2 months · daily API

Change History

5 versions recorded
  1. Apr 28, 2026 — Present [daily]

    Terminated

    Status: UnknownTerminated · Phase: PHASE2None

  2. Nov 2024 — Apr 2026 [monthly]

    Unknown PHASE2

    Status: RecruitingUnknown

  3. Sep 2024 — Nov 2024 [monthly]

    Recruiting PHASE2

  4. Jul 2024 — Sep 2024 [monthly]

    Recruiting PHASE2

  5. Jun 2022 — Jul 2024 [monthly]

    Recruiting PHASE2

    First recorded

May 2022

Trial started

Per CT.gov start date — pre-dates our first snapshot

Eligibility Summary

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

Contact Information

Sponsor contact:
  • Xuanwu Hospital, Beijing
Data source: ClinicalTrials.gov

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations