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

Phase 3

Recruiting

• Conditions: Neuromyelitis Optica Spectrum Disorder
• Interventions: Other: Placebo; Drug: MIL62

• Registration Number: NCT05314010
• Lead Sponsor: Beijing Mabworks Biotech Co., Ltd.

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-03-29
• Study First Submitted QC: 2022-03-29
• Study First Posted: 2022-04-06
• Study Start: 2022-08-18
• Status Verified: 2024-10
• Primary Completion: 2025-02-21
• Last Update Submitted: 2025-05-14
• Last Update Posted: 2025-05-18
• Study Completion: 2027-03

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 140

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	-
MIL62	MIL62	-

Primary Outcome Measures

Name	Time	Method
Time to Neuromyelitis Optica Spectrum Disorder (NMOSD) Attack During RCP	Up to 52 weeks	The NMOSD attack is defined as the presence of new or worsening symptom(s) related to NMOSD
Phase 1b: CD19+ B and CD20+ B lymphocyte ratio	Up to 52 weeks	Pharmacodynamics endpoint

Trial Locations

Locations (1)

Ethics Committee of Chinese PLA General Hosptial; 🇨🇳 Beijing, Beijing, China