Back to resultsEfficacy and Safety of Ruxolitinib in Neuromyelitis Optica Spectrum Disorders
Primary Purpose
Neuromyelitis Optica Spectrum Disorder Relapse
Status
Withdrawn
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
Ruxolitinib
Sponsored by
About this trial
This is an interventional basic science trial for Neuromyelitis Optica Spectrum Disorder Relapse
Eligibility Criteria
Inclusion Criteria: Male or female patients ≥ 18 years old; Diagnosis of NMO or NMO spectrum disorder according to the 2015 International diagnostic criteria for neuromyelitis optic; Clinical evidence of at least 2 relapses in last 12 months or 3 relapses in the last 24 months; EDSS <= 6.0; Rituximab should be used for at least 3 months if the condition is stable; Able and willing to give written informed consent and comply with the requirements of the study protocol. Exclusion Criteria: Current evidence or known history of clinically significant infection (Herpes simplex virus, varicella-zoster virus, cytomegalovirus, Epstein-Barr virus, human immunodeficiency virus, Hepatitis viruses, Syphilis, etc); Participation in another interventional trial within the last 3 months; Patients taking oral immunosuppressants such as azathioprine; Tumor disease currently or within last 5 years; Pregnant, breastfeeding, or child-bearing potential during the course of the study; Clinically relevant anemia, thrombocytopenia and dysfunction of the heart, liver, kidney or bone marrow.
Sites / Locations
- Tianjin Medical University General Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Ruxolitinib
Arm Description
Treatment with ruxolitinib will be initiated in an initial dose regimen of 5-10 mg twice daily. Two months later, the dose of ruxolitinib will be increased to 10-15 mg twice daily.
Outcomes
Primary Outcome Measures
time to the first protocol-defined relapse
An acute attack was defined as a new neurological worsening lasting for at least 24 hours and occurring more than 30 days after the previous attack.
Secondary Outcome Measures
Worsening in EDSS
The Expanded Disability Status Scale (EDSS) is a rating system that is frequently used for classifying and standardizing the severity and progression. EDSS ranges from 0 to 10.
Incidence of treatment-emergent adverse events [safety and tolerability]
Adverse events related to ruxolitinib are recorded
Full Information
NCT ID
NCT05909943
First Posted
March 8, 2023
Last Updated
June 10, 2023
Sponsor
Tianjin Medical University General Hospital
1. Study Identification
Unique Protocol Identification Number
NCT05909943
Brief Title
Efficacy and Safety of Ruxolitinib in Neuromyelitis Optica Spectrum Disorders
Official Title
Efficacy and Safety of Ruxolitinib in Neuromyelitis Optica Spectrum Disorders
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Withdrawn
Why Stopped
We are doing a clinical study of Baritinib in Neuromyelitis Optica Spectrum Disorders, similar to this one, so the study was withdrawn.
Study Start Date
June 1, 2024 (Anticipated)
Primary Completion Date
February 1, 2026 (Anticipated)
Study Completion Date
August 1, 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Tianjin Medical University General Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
Neuromyelitis Optica Spectrum Disorders (NMOSD) is associated with a pathological humoral immune response against the aquaporin-4(AQP-4) water channel. Rucotinib is an oral inhibitor of JAK1 and JAK2 tyrosine kinases. It may benefit some patients with NMOSD due to the important role of JAK/STAT signaling pathway in the pathogenesis of NMOSD. Clincial trials may be needed to observe its efficacy and safety.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neuromyelitis Optica Spectrum Disorder Relapse
7. Study Design
Primary Purpose
Basic Science
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Ruxolitinib
Arm Type
Experimental
Arm Description
Treatment with ruxolitinib will be initiated in an initial dose regimen of 5-10 mg twice daily. Two months later, the dose of ruxolitinib will be increased to 10-15 mg twice daily.
Intervention Type
Drug
Intervention Name(s)
Ruxolitinib
Intervention Description
Treatment with ruxolitinib will be initiated in an initial dose regimen of 5-10 mg twice daily. Two months later, the dose of ruxolitinib will be increased to 10-15 mg twice daily.
Primary Outcome Measure Information:
Title
time to the first protocol-defined relapse
Description
An acute attack was defined as a new neurological worsening lasting for at least 24 hours and occurring more than 30 days after the previous attack.
Time Frame
From baseline to one year after.
Secondary Outcome Measure Information:
Title
Worsening in EDSS
Description
The Expanded Disability Status Scale (EDSS) is a rating system that is frequently used for classifying and standardizing the severity and progression. EDSS ranges from 0 to 10.
Time Frame
Worsening from baseline in EDSS to 52 weeks
Title
Incidence of treatment-emergent adverse events [safety and tolerability]
Description
Adverse events related to ruxolitinib are recorded
Time Frame
From baseline to 52 weeks
Other Pre-specified Outcome Measures:
Title
Counts of peripheral blood B cell subsets
Description
Compare peripheral blood plasma cells before and one year after initial intervention.
Time Frame
From baseline to 52 weeks
Title
Number of New, and/or Enlarging T2 Hyperintense Lesions as Detected by Optic nerve,brain and spinal cord Magnetic Resonance Imaging (MRI)
Description
The total number of new and/or enlarging T2 lesions for all participants was calculated as the sum of the individual number of lesions at Weeks 12, 24, and 52.
Time Frame
From baseline to 52 weeks
Title
Determination of serum AQP4 antibodies
Description
Compare serum AQP4-ab titers before and one year after initial intervention.
Time Frame
From baseline to 52 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Male or female patients ≥ 18 years old; Diagnosis of NMO or NMO spectrum disorder according to the 2015 International diagnostic criteria for neuromyelitis optic; Clinical evidence of at least 2 relapses in last 12 months or 3 relapses in the last 24 months; EDSS <= 6.0; Rituximab should be used for at least 3 months if the condition is stable; Able and willing to give written informed consent and comply with the requirements of the study protocol.
Exclusion Criteria:
Current evidence or known history of clinically significant infection (Herpes simplex virus, varicella-zoster virus, cytomegalovirus, Epstein-Barr virus, human immunodeficiency virus, Hepatitis viruses, Syphilis, etc); Participation in another interventional trial within the last 3 months; Patients taking oral immunosuppressants such as azathioprine; Tumor disease currently or within last 5 years; Pregnant, breastfeeding, or child-bearing potential during the course of the study; Clinically relevant anemia, thrombocytopenia and dysfunction of the heart, liver, kidney or bone marrow.
Facility Information:
Facility Name
Tianjin Medical University General Hospital
City
Tianjin
State/Province
Tianjin
ZIP/Postal Code
300052
Country
China
12. IPD Sharing Statement
Learn more about this trial
Efficacy and Safety of Ruxolitinib in Neuromyelitis Optica Spectrum Disorders
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