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

NCT04670770 | Completed Phase 2 DMC

• 1 other identifier: RSB20621
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 8

Brief Summary

This is an open-label study, to evaluate the efficacy and safety of SHR1459 in participants with NMOSDs.

Conditions

Neuromyelitis Optica Spectrum Disorders

Outcome Measures

Primary Outcomes (1)

• 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.

  52 weeks

Secondary Outcomes (10)

• Comparison of the annualized relapse rate at 52 weeks of treatment with the year before screening.

  52 weeks

• Proportion of subjects who are relapse-free at week 24 and 52.

  52 weeks

• Changes in the expanded disability status scale (EDSS) at week 4, 12, 24, 36, and 52 compared to baseline.

  52 weeks

• Changes in low-contrast visual acuity (LCVA) score at week 4, 12, 24, 36 and 52 compared to baseline

  52 weeks

• Changes in cumulative active MRI lesion count at week 24 and 52 compared to baseline.

  52 weeks

Study Arms (1)

SHR1459

EXPERIMENTAL

SHR1459

Drug: Drug - SHR1459

Interventions

Drug - SHR1459 DRUG

Oral Tablets taken once daily for 52 weeks

SHR1459

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years of age.
• Diagnosis of AQP4-IgG positive NMOSD according to IPND diagnostic criteria 2015 at screening.
• Having a documented history of 2 or more NMOSD relapse required rescue therapy(ies) within the last 12 months.
• 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
• Written informed consent obtained before any study procedure.
• Subjects are willing and able to comply with the visit schedule and treatment plan, laboratory tests and other study procedures.

You may not qualify if:

• Allergic to the investigative product or any ingredient in the investigative product.
• Past or current malignancy, except for cutaneous non-metastatic basal cell carcinoma or squamous cell carcinoma that has been adequately treated or removed
• The subject currently has a central nervous system (CNS) disease that may affect the assessment of NMOSD;
• 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;
• The investigator judges that the subject has a disease that affects the absorption, distribution, metabolism and excretion of the drug;
• 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;
• 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.
• Or chest imaging examinations suggest the presence of active tuberculosis infection within 3 months before screening / during the screening period;
• Positive laboratory tests related to human immunodeficiency virus (HIV) or hepatitis B virus or hepatitis C virus;
• Have received BTK inhibitors (e.g. ibrutinib) at any time in the past.
• Received B-cell targeted therapy (such as rituximab) within 12 weeks before the first administration.
• Received biological agents such as eculizumab, tocilizumab, Satralizumab, Alemtuzumab, Natalizumab within 12 weeks before the first administration;

Sponsors & Collaborators

• Reistone Biopharma Company Limited: lead

Study Sites (8)

Xiangya Hospital Of Central South University

Changsha, China

Location

West China Hospital Sichuan University

Chengdu, China

Location

Lanzhou University Second Hospital

Lanzhou, China

Location

People's Hospital of Rizhao

Rizhao, China

Location

Huashan Hospital Affiliated To Fudan University

Shanghai, China

Location

First Hospital Of Shanxi Medical University

Taiyuan, China

Location

Tangdu Hosiptal

Xi'an, China

Location

The First Affiliated Hospital Of Zhengzhou University

Zhengzhou, China

Location

MeSH Terms

Conditions

Neuromyelitis Optica

Condition Hierarchy (Ancestors)

Myelitis, Transverse; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Optic Neuritis; Optic Nerve Diseases; Cranial Nerve Diseases; Demyelinating Diseases; Eye Diseases; Autoimmune Diseases; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 10, 2020
• First Posted: December 17, 2020
• Study Start: January 20, 2021
• Primary Completion: August 15, 2022
• Study Completion: August 15, 2022
• Last Updated: March 23, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (8)