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An Open Label Study of the Effects of SHR1459 in NMOSDs Patients | Clinical Trials | Clareo Health

COMPLETEDPHASE2

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)

NCT04670770•Reistone Biopharma Company Limited

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. 18-75 years of age.
•2. Diagnosis of AQP4-IgG positive NMOSD according to IPND diagnostic criteria 2015 at screening.
•3. Having a documented history of 2 or more NMOSD relapse required rescue therapy(ies) within the last 12 months.
•4. Subjects must be stable treatment (if any) for more than 1 month before starting the IP treatment, which is defined as follows:- Expanded disability status scale (EDSS) score≦7.5
•5. Written informed consent obtained before any study procedure.
•6. Subjects are willing and able to comply with the visit schedule and treatment plan, laboratory tests and other study procedures.

Exclusion Criteria

•1. Allergic to the investigative product or any ingredient in the investigative product.
•2. Past or current malignancy, except for cutaneous non-metastatic basal cell carcinoma or squamous cell carcinoma that has been adequately treated or removed
•3. The subject currently has a central nervous system (CNS) disease that may affect the assessment of NMOSD;
•4. Severe and uncontrolled conditions that the investigator determines may affect subjects' safety, trial compliance, evaluation of the end point, or the need to use medications not permitted in the protocol;
•5. The investigator judges that the subject has a disease that affects the absorption, distribution, metabolism and excretion of the drug;
•6. The subjects had any major clinical infection and was hospitalized or treated with parenteral antibiotics within 1 month before screening; Or other infections that investigator thought might aggravate as a result of participating in the study;
•7. The subject may have an active, latent or undertreated Mycobacterium tuberculosis (ie, tuberculosis \[TB\]) infection, defined as follows:
•* The result of QuantiFERON-TB Gold (QFT Gold test) was positive or the result of T-SPOT.TB was positive within 3 months before screening/screening period.
•* Or chest imaging examinations suggest the presence of active tuberculosis infection within 3 months before screening / during the screening period;
•* The result of QuantiFERON-TB Gold (QFT Gold test) was positive or the result of T-SPOT.TB was positive within 3 months before screening/screening period.
+20 more criteria

Locations (8)

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

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

Key Dates

Start Date

January 20, 2021

Primary Completion Date

August 15, 2022

Completion Date

August 15, 2022

Last Updated

March 23, 2023

Enrollment

ACTUAL participants

Conditions

Neuromyelitis Optica Spectrum Disorders

Interventions

Drug - SHR1459

DRUG

The Safety and Efficacy of NouvSoma001 in Neuromyelitis Optica Spectrum Disorders

NCT06620809

Neuromyelitis Optica Spectrum Disorders

View study

RECRUITING

Integrating Metabolism, Connectivity, and Mesoscale Imaging at Ultra-high Field to Decipher Mechanisms of Resilience and Neurodegeneration in Neurological Diseases and Healthy Aging

NCT07202494

Multiple SclerosisNeuromyelitis Optica Spectrum Disorders+8 more

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 23, 2023Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

An Open Label Study of the Effects of SHR1459 in NMOSDs Patients

Inclusion Criteria

Exclusion Criteria

The Safety and Efficacy of NouvSoma001 in Neuromyelitis Optica Spectrum Disorders

Integrating Metabolism, Connectivity, and Mesoscale Imaging at Ultra-high Field to Decipher Mechanisms of Resilience and Neurodegeneration in Neurological Diseases and Healthy Aging

A Clinical Study of B001 Injection in the Treatment of Neuromyelitis Optica Spectrum Disorders(NMOSD)

Efficacy and Safety of Divozilimab in Patients With Neuromyelitis Optica Spectrum Disorders (AQUARELLE)

Universal CAR-T Cells in Patients with Refractory Autoimmune Diseases of the Nervous System.

The French Cohort and Biobank of Devic's Neuromyelitis Optica and Related Neurological Disorders (NMOSD) (NOMADMUS)