Status:
UNKNOWN
A Study of Orelabrutinib in Patients With AQP4-IgG Positive Neuromyelitis Optica Spectrum Disorder
Lead Sponsor:
Peking Union Medical College Hospital
Collaborating Sponsors:
Beijing InnoCare Pharma Tech Co., Ltd.
GCP ClinPlus Co., Ltd.
Conditions:
Neuromyelitis Optica Spectrum Disorder
Eligibility:
All Genders
18-75 years
Phase:
NA
Brief 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-I...
Detailed Description
Approximately 23 subjects will be enrolled. Experimental drug treatment: Orelabrutinib, 50mg, orally, once a day. The subject will come to visit at week 0, 1, 2, 4, 8, 12, 16, 20, 24, 36, 48 and saf...
Eligibility Criteria
Inclusion
- 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
- 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: ① Received 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 study drug or other experimental treatment within 4 weeks before screening or 5 half-lives, or participating in any other intervention clinical trial.
- 5\) During screening or baseline examination, laboratory results meet the exclusion criteria:
- Human immunodeficiency virus (HIV) positive
- Hepatitis C virus (HCV) antibody positive. (If a subject has a history of HCV infection, has completed and recorded appropriate treatment at least 1 year before screening, and the HCV RNA measured by PCR at the time of screening is negative, the subject will not be excluded from this study.)
- Hepatitis B surface antigen (HBsAg) positive and / or hepatitis B core antibody (HBcAb) positive
- Estimated glomerular filtration rate (eGFR) \< 30 mL/min/1.73 m2
- ALT/AST \> 2 x ULN, Total Bilirubin \> 1.5 x ULN, or any other clinically significant laboratory abnormality
- Neutrophil \< 1500 / mm3, platelet \< 75000 / mm3, lymphocyte \< 1000 / mm3 or leukocyte \< 3500 / mm3.
- International standardized ratio (INR) ≥ 1.5 or activated partial thromboplastin time (APTT) ≥ 1.5x ULN.
- CD19 B cells lower than the lower limit of the normal range
- 6\) Used strong to medium CYP3A inducers within 3 weeks before treatment, or strong to medium CYP3A inhibitors within 1 week before treatment, or strong to medium CYP3A inducers or inhibitors may be used during treatment.
- 7\) There are situations that other researchers think are not suitable to participate in this study.
Key Trial Info
Start Date :
April 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2023
Estimated Enrollment :
23 Patients enrolled
Trial Details
Trial ID
NCT05284175
Start Date
April 1 2022
End Date
August 1 2023
Last Update
March 17 2022
Active Locations (1)
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1
Peking Union Medical College Hospital, Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, China, 100730