An Open Label Study of the Effects and Safety of Zanubrutinib in NMOSDs Adult Patients (NCT05356858) | Clinical Trial Compass
TerminatedPhase 2
An Open Label Study of the Effects and Safety of Zanubrutinib in NMOSDs Adult Patients
Stopped: Difficult in participant recruiting
China6 participantsStarted 2022-05-07
Plain-language summary
This is an open-label study, to evaluate the efficacy and safety of a BTK inhibitor zanubrutinib in participants with NMOSDs.
Who can participate
Age range18 Years – 75 Years
SexALL
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Inclusion Criteria:
* Patients must meet the NMOSD diagnostic criteria set by the international NMO Diagnostic Group (IPND) in 2015.
* Serum AQP4-IgG positive.
* Clinical evidence of at least 2 documented relapse (including first attack) in the last 2 years, with at least 1 relapse within 12 months prior to screening.
* Extended Disability Status Scale (EDSS) score ≤7.5 at screening.
* Age 18 to 75 years inclusive, weight at least 35 kg at the time of informed consent.
* If the patients were using the following baseline treatment for relapse prevention, they must be treated at a steady dose for at least 4 weeks prior to enrollment:
* Azathioprine, metecophenol ester and other immunosuppressive agents
* Oral corticosteroid (≦30mg/ day prednisone tablet or equivalent dose of other hormones)
* (patients or their legal representatives) can provide written informed consent indicating that they understand and agree to comply with the requirements of the study protocol.
Exclusion Criteria:
* Continuous treatment with strong or moderate CYP3A inhibitors or inducers is required during the study period. Patients were excluded if they had taken a potent or moderate CYP3A inhibitor or inducer within 7 days prior to administration of the study drug (or had stopped taking these drugs for less than 5 half-lives).
* Previously treated with BTK inhibitors (e.g., ibrutinib).
* Allergic to the study drug or any of the ingredient.
* Desease relaps (including first episode) within the pre…