This is an open-label study, to evaluate the efficacy and safety of SHR1459 in participants with NMOSDs.
Therefore, the investigators of this study are investigating whether SHR1459 could prevent relapse of NMOSDs. The primary objective of this study is to evaluate the effectiveness of SHR1459 in NMOSDs patients. The secondary objectives are to determine: The safety profile of SHR 1459 in patients with NMOSDs. Whether SHR1459 reduce MRI lesions and APQ4-Abs level.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
10
Oral Tablets taken once daily for 52 weeks
Xiangya Hospital Of Central South University
Changsha, China
West China Hospital Sichuan University
Chengdu, China
Lanzhou University Second Hospital
Lanzhou, China
People's Hospital of Rizhao
Rizhao, China
Evaluate the efficacy of SHR1459 in patients with relapsing NMOSDs
Comparison of the annualized relapse rate at 52 weeks of treatment with the annualized recurrence rate before screening.
Time frame: 52 weeks
Comparison of the annualized relapse rate at 52 weeks of treatment with the year before screening.
Comparison of the annualized relapse rate at 52 weeks of treatment with the year before screening.
Time frame: 52 weeks
Proportion of subjects who are relapse-free at week 24 and 52.
Proportion of subjects who are relapse-free at week 24 and 52.
Time frame: 52 weeks
Changes in the expanded disability status scale (EDSS) at week 4, 12, 24, 36, and 52 compared to baseline.
Changes in the expanded disability status scale (EDSS) at week 4, 12, 24, 36, and 52 compared to baseline.
Time frame: 52 weeks
Changes in low-contrast visual acuity (LCVA) score at week 4, 12, 24, 36 and 52 compared to baseline
Changes in low-contrast visual acuity (LCVA) score at week 4, 12, 24, 36 and 52 compared to baseline.
Time frame: 52 weeks
Changes in cumulative active MRI lesion count at week 24 and 52 compared to baseline.
Changes in cumulative active MRI lesion count at week 24 and 52 compared to baseline.
Time frame: 52 weeks
Changes in health related quality of life (HRQoL) at week 12, 24, 36 and 52 compared to baseline.
Changes in health related quality of life (HRQoL) at week 12, 24, 36 and 52 compared to baseline.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Huashan Hospital Affiliated To Fudan University
Shanghai, China
First Hospital Of Shanxi Medical University
Taiyuan, China
Tangdu Hosiptal
Xi'an, China
The First Affiliated Hospital Of Zhengzhou University
Zhengzhou, China
Time frame: 52 weeks
Changes in pain severity score (NRS) at week 4, 12, 24, 36 and 52 compared to baseline.
Changes in pain severity score (NRS) at week 4, 12, 24, 36 and 52 compared to baseline.
Time frame: 52 weeks
Changes in serum AQP4-IgG titer from baseline at 4, 12, 24, 36, 52 weeks.
Changes in serum AQP4-IgG titer from baseline at 4, 12, 24, 36, 52 weeks.
Time frame: 52 weeks
Changes in the absolute value of B lymphocytes and total immunoglobulins (IgA, IgG and IgM) from baseline after 12, 24, and 52 weeks of treatment.
Changes in the absolute value of B lymphocytes and total immunoglobulins (IgA, IgG and IgM) from baseline after 12, 24, and 52 weeks of treatment
Time frame: 52 weeks
The plasma concentration of SHR1459 and its metabolite SHR1459-02 in NMOSD patients.
The plasma concentration of SHR1459 and its metabolite SHR1459-02 in NMOSD patients
Time frame: 52 weeks