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

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

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

Study Overview

• Status: Recruiting
• Conditions: Neuromyelitis Optica Spectrum Disorder
• Intervention / Treatment: Drug: MIL62; Other: Placebo

• Study Type: Interventional
• Enrollment (Estimated): 140
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Dehui Huang, doctor; Phone Number: 8610-55499036; Email: huangdehui@gmail.com

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China
      • Recruiting
      • Ethics Committee of Chinese PLA General Hosptial
      • Contact: Dehui Huang, doctor; Phone Number: 8610-55499036

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	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.
Experimental: MIL62	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Phase 1b: CD19+ B and CD20+ B lymphocyte ratio	Pharmacodynamics endpoint	Up to 52 weeks
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

Collaborators and Investigators

• Sponsor: Beijing Mabworks Biotech Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): August 18, 2022
• Primary Completion (Estimated): March 1, 2025
• Study Completion (Estimated): March 1, 2027

Study Registration Dates

• First Submitted: March 29, 2022
• First Submitted That Met QC Criteria: March 29, 2022
• First Posted (Actual): April 6, 2022

Study Record Updates

• Last Update Posted (Actual): August 14, 2023
• Last Update Submitted That Met QC Criteria: August 9, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Immune System Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Autoimmune Diseases; Eye Diseases; Optic Nerve Diseases; Cranial Nerve Diseases; Myelitis, Transverse; Optic Neuritis; Neuromyelitis Optica
• Other Study ID Numbers: MIL62-CT303

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No