A Study of Obexelimab in Patients With Relapsing Multiple Sclerosis (MoonStone)
- Conditions
- Relapsing Multiple Sclerosis
- Registration Number
- NCT06564311
- Lead Sponsor
- Zenas BioPharma (USA), LLC
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 93
Inclusion Criteria:<br><br> 1. Diagnosis of RMS (relapsing-remitting or secondary progressive with relapses)<br> according to the 2017 revision of the McDonald diagnostic criteria<br><br> 2. An EDSS of = 5.5 at the Screening Visit<br><br> 3. Must have documentation of:<br><br> 1. . at least 1 relapse within the previous year OR<br><br> 2. . = 2 relapses within the past 2 years OR<br><br> 3. . = 1 active Gd-enhancing brain lesion on an MRI scan within the past 6 months<br> prior to screening<br><br> 4. Not of childbearing potential or willing to follow contraceptive guidance<br><br>Exclusion Criteria:<br><br> 1. Primary progressive MS or secondary progressive MS without relapses<br><br> 2. Meet criteria for neuromyelitis optica spectrum disorder<br><br> 3. Relapse in the 30 days prior to randomization<br><br> 4. = 10 years disease duration from onset with patient's EDSS = 2.0 (patient reported<br> is adequate in absence of written medical record)<br><br> 5. Has > 20 Gd+ lesions on brain MRI at screening
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Cumulative number of new GdE T1 hyperintense lesions
- Secondary Outcome Measures
Name Time Method Number of T2 Lesions;Number of GdE T1 lesions;Volume of T2 lesions;Serum NfL;Incidence of Adverse Events, injection site reactions and hypersensitivity reactions