A Study of Obexelimab in Patients With Relapsing Multiple Sclerosis (MoonStone)
NCT ID: NCT06564311
Last Updated: 2025-11-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE2
93 participants
INTERVENTIONAL
2024-08-26
2026-02-28
Brief Summary
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Detailed Description
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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, a 12-week Open-Label Period (OLP), during which all patients will receive obexelimab administered as weekly SC injections. After Part B, patients will enter Part C, a 52-week Open-Label Extension (OLE), after which they will return for an in-clinic Safety Follow-Up Visit 12 weeks after the completion of Part C (i.e. Week 88). 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 92 weeks (Screening Period = 4 weeks, Parts A, B and C = 76 weeks, Follow-up Period = 12 weeks).
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Obexelimab
Obexelimab will be administered as a subcutaneous injection for 76 weeks
Obexelimab
Obexelimab is a monoclonal antibody that simultaneously binds CD19 and FcyRIIb, resulting in down regulation of B cell activity
Placebo
Placebo will be administered as a subcutaneous injection for 12 weeks
Placebo
Placebo
Interventions
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Obexelimab
Obexelimab is a monoclonal antibody that simultaneously binds CD19 and FcyRIIb, resulting in down regulation of B cell activity
Placebo
Placebo
Eligibility Criteria
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Inclusion Criteria
2. An EDSS of ≤ 5.5 at the Screening Visit
3. Must have documentation of:
1. . at least 1 relapse within the previous year OR
2. . ≥ 2 relapses within the past 2 years OR
3. . ≥ 1 active Gd-enhancing brain lesion on an MRI scan within the past 6 months prior to screening
4. Not of childbearing potential or willing to follow contraceptive guidance
Exclusion Criteria
2. Meet criteria for neuromyelitis optica spectrum disorder
3. Relapse in the 30 days prior to randomization
4. ≥ 10 years disease duration from onset with patient's EDSS ≤ 2.0 (patient reported is adequate in absence of written medical record)
5. Has \> 20 Gd+ lesions on brain MRI at screening
18 Years
60 Years
ALL
No
Sponsors
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Zenas BioPharma (USA), LLC
INDUSTRY
Responsible Party
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Locations
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North Central Neurology
Cullman, Alabama, United States
Center for Neurology and Spine
Phoenix, Arizona, United States
Perseverance Research Center
Scottsdale, Arizona, United States
Regina Berkovich MD PhD, Inc
West Hollywood, California, United States
Aqualine Clinical Research
Naples, Florida, United States
University of South Florida
Tampa, Florida, United States
University of Massachusetts Medical School
Worcester, Massachusetts, United States
Infusion Associates Plymouth
Plymouth, Minnesota, United States
MS Center for Innovations in Care
St 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
Center for Neurological Disorders
Greenfield, Wisconsin, United States
Medical College of Wisconsin
Milwaukee, Wisconsin, United States
Neuro-logisch Wien
Vienna, , Austria
Rehabilitation & MS Center, Noorderhart Hospital
Overpelt, , Belgium
AZ Delta-Deltalaan 1
Roeselare, , Belgium
Tiantan Hospital, Capital Medical University
Beijing, , China
The First Affiliation Hospital of Soochow University
Suzhou, , China
Tianjin Medical University General Hospital
Tianjin, , China
People's Hospital of Xinjiang Uyaur Autonomous Region
Ürümqi, , China
Tongji Hospital, Tongji Medical Center of HUST
Wuhan, , China
Klinicki bolnicki centar Zagreb
Zagreb, , Croatia
Fakultni nemocnice u sv. Anny v Brne
Brno, , Czechia
Nemocnice Jihlava
Jihlava, , Czechia
General University Hospital Praha
Prague, , 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
Hospital Universitario Virgen de La Arrixaca
Murcia, , Spain
Hospital Virgen Macarena
Seville, , Spain
Hospipal La Fe Valencia
Valencia, , Spain
Leicester General Hospital
Leicester, , United Kingdom
Barts Health NHS Trust
London, , United Kingdom
Morriston Hospital
Swansea, , United Kingdom
Countries
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Other Identifiers
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ZB012-02-002
Identifier Type: -
Identifier Source: org_study_id
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