Status:
ACTIVE_NOT_RECRUITING
A Study of Obexelimab in Patients With Relapsing Multiple Sclerosis (MoonStone)
Lead Sponsor:
Zenas BioPharma (USA), LLC
Conditions:
Relapsing Multiple Sclerosis
Eligibility:
All Genders
18-60 years
Phase:
PHASE2
Brief Summary
This study aims to examine the efficacy and safety of obexelimab in participants with relapsing multiple sclerosis
Detailed Description
The study consists of a Screening Period (Day -28 to Day -1), a 24-week treatment period (Part A and Part B), a 52 week open label extension and an expected 12-week Follow-up Period. Patients with Rel...
Eligibility Criteria
Inclusion
- Diagnosis of RMS (relapsing-remitting or secondary progressive with relapses) according to the 2017 revision of the McDonald diagnostic criteria
- An EDSS of ≤ 5.5 at the Screening Visit
- Must have documentation of:
- . at least 1 relapse within the previous year OR
- . ≥ 2 relapses within the past 2 years OR
- . ≥ 1 active Gd-enhancing brain lesion on an MRI scan within the past 6 months prior to screening
- Not of childbearing potential or willing to follow contraceptive guidance
Exclusion
- Primary progressive MS or secondary progressive MS without relapses
- Meet criteria for neuromyelitis optica spectrum disorder
- Relapse in the 30 days prior to randomization
- ≥ 10 years disease duration from onset with patient's EDSS ≤ 2.0 (patient reported is adequate in absence of written medical record)
- Has \> 20 Gd+ lesions on brain MRI at screening
Key Trial Info
Start Date :
August 26 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 1 2026
Estimated Enrollment :
93 Patients enrolled
Trial Details
Trial ID
NCT06564311
Start Date
August 26 2024
End Date
February 1 2026
Last Update
November 17 2025
Active Locations (47)
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1
North Central Neurology
Cullman, Alabama, United States, 35058
2
Center for Neurology and Spine
Phoenix, Arizona, United States, 85032
3
Perseverance Research Center
Scottsdale, Arizona, United States, 85253
4
Regina Berkovich MD PhD, Inc
West Hollywood, California, United States, 90048