A Study of Obexelimab in Patients With Relapsing Multiple Sclerosis (MoonStone)
- Registration Number
- NCT06564311
- Lead Sponsor
- Zenas BioPharma (USA), LLC
- 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), and an expected 12-week Follow-up Period. Patients with Relapsing Multiple Sclerosis will be randomized in 2:1 ratio to obexelimab or placebo. Randomization will be stratified by Gd lesion status at screening (≥ 1 vs 0).
Part A is the 12-week Randomized Placebo-Controlled Period (RCP), during which obexelimab or placebo will be administered as weekly subcutaneous (SC) injections. Following Part A, all patients will enter the Part B, Open-Label Period (OLP), during which all patients will receive obexelimab administered as weekly SC injections. Patients will return for an in-clinic Safety Follow-Up Visit 12 weeks after the completion of Part B (i.e. Week 36). If at this time, B cells have not returned to baseline or above the lower limit of normal (LLN), patients will be asked to return every 12 weeks until B cells return to baseline or above the LLN (at minimum). The maximum expected duration of the study is 40 weeks (Screening Period = 4 weeks, Parts A and B = 24 weeks, Follow-up Period = 12 weeks).
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 93
-
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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Obexelimab Obexelimab Obexelimab will be administered as a subcutaneous injection for 24 weeks Placebo Placebo Placebo will be administered as a subcutaneous injection for 12 weeks
- Primary Outcome Measures
Name Time Method Cumulative number of new GdE T1 hyperintense lesions Week 8 and Week 12 Cumulative number of new GdE T1 hyperintense lesions as measured by brain MRI
- Secondary Outcome Measures
Name Time Method Volume of T2 lesions Week 12 change from baseline in volume of T2 lesions
Number of T2 Lesions Week 8 and Week 12 cumulative number of new and/or enlarging T2 weighted hyperintense lesions
Number of GdE T1 lesions Week 4, Week 8, and Week 12 number of new GdE T1 hyperintense lesions
Serum NfL Week 12 serum NfL
Incidence of Adverse Events, injection site reactions and hypersensitivity reactions 24 weeks Incidence of Adverse Events, injection site reactions and hypersensitivity reactions, serious adverse events, and adverse events of special interest, as defined by the CTCAE v5.0
Trial Locations
- Locations (30)
University of Massachusetts Medical School
🇺🇸Worcester, Massachusetts, United States
Fakultni nemocnice u sv. Anny v Brne
🇨🇿Brno, Czechia
Regina Berkovich MD PhD, Inc
🇺🇸West Hollywood, California, United States
Aqualine Clinical Research
🇺🇸Naples, Florida, United States
Sharlin Health Neuroscience Research
🇺🇸Ozark, Missouri, United States
MS Center for Innovations in Care
🇺🇸Saint Louis, Missouri, United States
Holy Name Medical Center
🇺🇸Teaneck, New Jersey, United States
Boster Center for MS
🇺🇸Columbus, Ohio, United States
North Texas Institute of Neurology and Headache
🇺🇸Plano, Texas, United States
MS Center of Greater Washington
🇺🇸Vienna, Virginia, United States
Center for Neurological Disorders
🇺🇸Greenfield, Wisconsin, United States
AZ Delta-Deltalaan 1
🇧🇪Roeselare, Belgium
Klinicki bolnicki centar Zagreb
🇭🇷Zagreb, Croatia
Nemocnice Jihlava
🇨🇿Jihlava, Czechia
Aalborg Universitetshospital
🇩🇰Aalborg, Denmark
Attikon University General Hospital
🇬🇷Chaïdári, Greece
University General Hospital of Larissa
🇬🇷Larissa, Greece
Fondazione Isituto G. Giglio di Cefalu
🇮🇹Cefalù, Italy
University of Florence
🇮🇹Florence, Italy
Istituto Neurologico Mediterraneo Neuromed
🇮🇹Pozzilli, Italy
Fondazione PTV Policlinico Tor Vergata
🇮🇹Roma, Italy
Neurocentrum Bydgoszcz sp.z o.o.
🇵🇱Bydgoszcz, Poland
M.A. LEK A.M. Maciejowsy Spolka Cywilna
🇵🇱Katowice, Poland
Zanamed Medical Clinic Sp z o.o.
🇵🇱Lublin, Poland
Wielospecjalistyczne Centrum Medyczne Ibismed
🇵🇱Zabrze, Poland
Hospital Clinico San Carlos
🇪🇸Madrid, Spain
Hospital General Universitario Gregorio Marañon
🇪🇸Madrid, Spain
Hospital Regional Universitario de Malaga - Hospital General
🇪🇸Málaga, Spain
Hospital Regional Universitario de Malaga
🇪🇸Málaga, Spain
Hospipal La Fe Valencia
🇪🇸Valencia, Spain