A Study of MIL62 in Patients With Neuromyelitis Optica Spectrum Disorder (NMOSD)

Neuromyelitis Optica Spectrum Disorder Clinical Trial

Official title:

A Multicenter, Phase Ib/III Study to Evaluate the Safety and Efficacy of MIL62 in Patients With Neuromyelitis Optica Spectrum Disorder (NMOSD)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05314010
• Other study ID #: MIL62-CT303
• Status: Recruiting
• Phase: Phase 3
• Start date: August 18, 2022
• Est. completion date: March 2027

Study information

• Verified date: August 2023
• Source: Beijing Mabworks Biotech Co., Ltd.
• Contact: Dehui Huang, doctor
• Phone: 8610-55499036
• Email: huangdehui[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study will evaluate the safety and efficacy of MIL62 in patients with Neuromyelitis Optica Spectrum Disorder.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 140
• Est. completion date: March 2027
• Est. primary completion date: March 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

1. Patient with NMOSD as defined by 2015 NMOSD diagnostic criteria by IPND (International Panel for NMO Diagnosis) with anti-AQP4-IgG seropositive status.

2. Male or female aged 18~60 years.

3. Expanded Disability Status Scale(EDSS) score =6.5.

4. 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.

5. 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:

1. 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).

2. Receipt of tocilizumab, eculizumab within 3 months prior to the first administration.

3. 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 .

4. Receipt of IVIG, plasmapheresis or blood transfusion within 28 days prior to the first administration.

5. Any live or attenuated vaccine within 28 days prior to the first administration.

Related Conditions & MeSH terms

• Neuromyelitis Optica
• Neuromyelitis Optica Spectrum Disorder

Intervention

Drug:
• MIL62
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.

Other:
• Placebo
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.

Locations

Country	Name	City	State
China	Ethics Committee of Chinese PLA General Hosptial	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Beijing Mabworks Biotech Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Phase 1b: CD19+ B and CD20+ B lymphocyte ratio	Pharmacodynamics endpoint	Up to 52 weeks
Primary	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	Up to 52 weeks