Trials / Completed
CompletedNCT04670770
An Open Label Study of the Effects of SHR1459 in NMOSDs Patients
An Open Label Phase II Clinical Trial Evaluating the Efficacy and Safety of SHR1459 in Adult Patients With Neuromyelitis Optical Spectrum Disorders (NMOSDs)
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 10 (actual)
- Sponsor
- Reistone Biopharma Company Limited · Industry
- Sex
- All
- Age
- 18 Years – 75 Years
- Healthy volunteers
- Not accepted
Summary
This is an open-label study, to evaluate the efficacy and safety of SHR1459 in participants with NMOSDs.
Detailed description
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Drug - SHR1459 | Oral Tablets taken once daily for 52 weeks |
Timeline
- Start date
- 2021-01-20
- Primary completion
- 2022-08-15
- Completion
- 2022-08-15
- First posted
- 2020-12-17
- Last updated
- 2023-03-23
Locations
8 sites across 1 country: China
Source: ClinicalTrials.gov record NCT04670770. Inclusion in this directory is not an endorsement.