Clinical Trials in Spain / NCT06564311
Active, not recruiting
Phase 2
A Study of Obexelimab in Patients With Relapsing Multiple Sclerosis (MoonStone)
NCT06564311 · tracked via the Priya Life Science Spain tracker
Condition(s) studied
Relapsing Multiple Sclerosis
Investigational drug(s) / intervention(s)
Obexelimab →Placebo
Obexelimab: Obexelimab is a monoclonal antibody that simultaneously binds CD19 and FcyRIIb, resulting in down regulation of B cell activity
Placebo: Placebo
Study summary
This study aims to examine the efficacy and safety of obexelimab in participants with relapsing multiple sclerosis
Eligibility
Inclusion Criteria:
1. Diagnosis of RMS (relapsing-remitting or secondary progressive with relapses) according to the 2017 revision of the McDonald diagnostic 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:
1. Primary progressive MS or secondary progressive MS without relapses
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
Primary outcome measure(s)
- 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
Trial sites (47)
| Facility | City | Region | Status |
|---|---|---|---|
| North Central Neurology | Cullman | Alabama | |
| Center for Neurology and Spine | Phoenix | Arizona | |
| Perseverance Research Center | Scottsdale | Arizona | |
| Regina Berkovich MD PhD, Inc | West Hollywood | California | |
| Aqualine Clinical Research | Naples | Florida | |
| University of South Florida | Tampa | Florida | |
| University of Massachusetts Medical School | Worcester | Massachusetts | |
| Infusion Associates Plymouth | Plymouth | Minnesota | |
| MS Center for Innovations in Care | St Louis | Missouri | |
| Holy Name Medical Center | Teaneck | New Jersey | |
| Boster Center for MS | Columbus | Ohio | |
| North Texas Institute of Neurology and Headache | Plano | Texas | |
| Center for Neurological Disorders | Greenfield | Wisconsin | |
| Medical College of Wisconsin | Milwaukee | Wisconsin | |
| 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 |
+ 7 more sites — see the full list on the official registry below.
More Zenas BioPharma (USA), LLC trials in Spain
A Study of Obexelimab in Patients With Systemic Lupus Erythematosus
Active, not recruiting
A Study of Obexelimab in Patients With Warm Autoimmune Hemolytic Anemia (SApHiAre)
Active, not recruiting
A Phase 3 Study of Obexelimab in Patients With IgG4-Related Disease
Active, not recruiting
Other trials for the same condition
Efficacy and Safety of Remibrutinib Compared to Teriflunomide in Participants With Relapsing Multiple Sclerosis (RMS) (REMODEL-2)
Active, not recruiting
A Study to Evaluate the Efficacy and Safety of Fenebrutinib Compared With Teriflunomide in Relapsing Multiple Sclerosis (RMS)
Active, not recruiting
Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT06564311 on ClinicalTrials.gov ↗ ← All trials in Spain