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 range
18 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.