A Study of Orelabrutinib in Patients With AQP4-IgG Positive Neuromyelitis Optica Spectrum Disorder (NCT05284175) | Clinical Trial Compass
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A Study of Orelabrutinib in Patients With AQP4-IgG Positive Neuromyelitis Optica Spectrum Disorder
China23 participantsStarted 2022-04
Plain-language summary
Neuromyelitis optica spectrum disorder (NMOSD) is a chronic inflammatory demyelinating autoimmune disease of the central nervous system. NMOSD is a highly relapsing, severely disabling disease. AQP4-IgG positive NMOSD is related to a specific aquaporin 4 antibody (AQP4 IgG) produced by mature B cells. BTK is a key kinase in B cell receptor signal transduction pathway. Abnormal activation of BTK related signaling pathway can lead to autoantibody production and autoimmune diseases. Therefore, BTK can be developed as a new target for autoimmune diseases.
Who can participate
Age range18 Years – 75 Years
SexALL
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Inclusion Criteria:
* 1\) 18-75 years old (inclusive) at the time of signing the informed consent form
* 2)Diagnosed with AQP4-IgG positive NMOSD in accordance with 2015 IPND diagnostic criteria.
* 3)Relapse ≥ 2 within 1 year before screening, and at least 1 relapse within 6 months before screening
* 4)If the subject has stable steroids treatment (≤ 7.5mg prednisone, or equivalent dose of steroids), the treatment needs to be stable more than 1 month before starting the study drug treatment.
* 5)EDSS ≤7.5 at screening
* 6)Negative pregnancy test for female of childbearing potential at screening
* 7)Understood the study procedure and voluntarily signed written informed consent
Exclusion Criteria:
* 1\) History of serious heart, lung, liver, kidney, blood disease, etc.
* 2\) Any major infection judged by the investigator requiring hospitalization and parenteral antimicrobial treatment within 1 month before screening
* 3\) History of episodes of herpes zoster ≥ 2 or disseminated herpes zoster ≥ 1
* 4\) History of or having any of the following medication / treatment: ①Received BTK inhibitor at any time in the past; ② B-cell targeted therapy within 12 weeks before the first dose; ③ Received biological agents within 12 weeks before the first dose; ④ Received live virus vaccine or live attenuated vaccine within 8 weeks before the first dose; ⑤ Received steroids treatment for other diseases within 6 months before screening, the dosage \> 20mg / day for more than 21 days; ⑥ Used a…
What they're measuring
1
Annualized relapse rate at week 48 compared with that before baseline.