Back to resultsA Study of MIL62 in Patients With Neuromyelitis Optica Spectrum Disorder (NMOSD)
Primary Purpose
Neuromyelitis Optica Spectrum Disorder
Status
Recruiting
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
MIL62
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Neuromyelitis Optica Spectrum Disorder
Eligibility Criteria
Inclusion Criteria:
- Patient with NMOSD as defined by 2015 NMOSD diagnostic criteria by IPND (International Panel for NMO Diagnosis) with anti-AQP4-IgG seropositive status.
- Male or female aged 18～60 years.
- Expanded Disability Status Scale(EDSS) score ≤6.5.
- A documented history of at least one attack requiring rescue therapy in the last year or two attacks requiring rescue therapy in the last 2 years prior to screening.
- Subjects who have had a relapse immediately prior to screening must have at least 12 weeks in which their relapse symptoms are stable prior to the first administration.
Exclusion Criteria:
- CD20+ B cell counts below the lower limit of normal (LLN). Receipt of rituximab or any B-cell depleting agent within the 6 months prior to screening, unless the subject has B-cell counts above the LLN. CD4 T lymphocyte count <300 cells/μL(CD4：CD8≤1.4).
- Receipt of tocilizumab, eculizumab within 3 months prior to the first administration.
- Receipt of any of the following prior to the first administration: Azathioprine,Mycophenolate mofetil,Tacrolimus,Cyclosporin, Methotrexate,Cyclophosphamide,and Patients discontinued more than 5 times the half-life of the drug before they could get into the group .
- Receipt of IVIG, plasmapheresis or blood transfusion within 28 days prior to the first administration.
- Any live or attenuated vaccine within 28 days prior to the first administration.
Sites / Locations
- Ethics Committee of Chinese PLA General HosptialRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
MIL62
Placebo
Arm Description
Outcomes
Primary Outcome Measures
Phase 1b: CD19+ B and CD20+ B lymphocyte ratio
Pharmacodynamics endpoint
Time to Neuromyelitis Optica Spectrum Disorder (NMOSD) Attack During RCP
The NMOSD attack is defined as the presence of new or worsening symptom(s) related to NMOSD
Secondary Outcome Measures
Full Information
NCT ID
NCT05314010
First Posted
March 29, 2022
Last Updated
August 9, 2023
Sponsor
Beijing Mabworks Biotech Co., Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT05314010
Brief Title
A Study of MIL62 in Patients With Neuromyelitis Optica Spectrum Disorder (NMOSD)
Official Title
A Multicenter, Phase Ib/III Study to Evaluate the Safety and Efficacy of MIL62 in Patients With Neuromyelitis Optica Spectrum Disorder (NMOSD)
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 18, 2022 (Actual)
Primary Completion Date
March 2025 (Anticipated)
Study Completion Date
March 2027 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Beijing Mabworks Biotech Co., Ltd.
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
This study will evaluate the safety and efficacy of MIL62 in patients with Neuromyelitis Optica Spectrum Disorder.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neuromyelitis Optica Spectrum Disorder
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
140 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
MIL62
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
MIL62
Intervention Description
Phase 1b:participants will receive IV MIL62 500 mg or 1000 mg on Day 1 and Day 15.
Phase 3:Participants will receive IV MIL62 on Day 1, Day 15 and Day 183 of the RCP at the dose confirmed in the phase Ib. The participants who enter the OLP will receive IV MIL62 on Day 1 and matching placebo on Day 15, followed by a single IV dose of MIL62 every 6 months until maximum of 6 months after the last participant enters the OLP.
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Phase 3:Participants will receive IV placebo matched to MIL62 on Day 1, Day 15 and Day 183 of the RCP. The participants who enter the OLP will receive IV MIL62 on both Day 1 and Day 15, followed by a single IV dose of MIL62 every 6 months until maximum of 6 months after the last participant enters the OLP.
Primary Outcome Measure Information:
Title
Phase 1b: CD19+ B and CD20+ B lymphocyte ratio
Description
Pharmacodynamics endpoint
Time Frame
Up to 52 weeks
Title
Time to Neuromyelitis Optica Spectrum Disorder (NMOSD) Attack During RCP
Description
The NMOSD attack is defined as the presence of new or worsening symptom(s) related to NMOSD
Time Frame
Up to 52 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patient with NMOSD as defined by 2015 NMOSD diagnostic criteria by IPND (International Panel for NMO Diagnosis) with anti-AQP4-IgG seropositive status.
Male or female aged 18～60 years.
Expanded Disability Status Scale(EDSS) score ≤6.5.
A documented history of at least one attack requiring rescue therapy in the last year or two attacks requiring rescue therapy in the last 2 years prior to screening.
Subjects who have had a relapse immediately prior to screening must have at least 12 weeks in which their relapse symptoms are stable prior to the first administration.
Exclusion Criteria:
CD20+ B cell counts below the lower limit of normal (LLN). Receipt of rituximab or any B-cell depleting agent within the 6 months prior to screening, unless the subject has B-cell counts above the LLN. CD4 T lymphocyte count <300 cells/μL(CD4：CD8≤1.4).
Receipt of tocilizumab, eculizumab within 3 months prior to the first administration.
Receipt of any of the following prior to the first administration: Azathioprine,Mycophenolate mofetil,Tacrolimus,Cyclosporin, Methotrexate,Cyclophosphamide,and Patients discontinued more than 5 times the half-life of the drug before they could get into the group .
Receipt of IVIG, plasmapheresis or blood transfusion within 28 days prior to the first administration.
Any live or attenuated vaccine within 28 days prior to the first administration.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Dehui Huang, doctor
Phone
8610-55499036
Email
huangdehui@gmail.com
Facility Information:
Facility Name
Ethics Committee of Chinese PLA General Hosptial
City
Beijing
State/Province
Beijing
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dehui Huang, doctor
Phone
8610-55499036
12. IPD Sharing Statement
Learn more about this trial
A Study of MIL62 in Patients With Neuromyelitis Optica Spectrum Disorder (NMOSD)
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