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Clinical Trials in Italy / NCT06564311
Active, not recruiting Phase 2

A Study of Obexelimab in Patients With Relapsing Multiple Sclerosis (MoonStone)

NCT06564311 · tracked via the Priya Life Science Italy tracker
Phase
Phase 2
Started
2024-08-26
Last updated
2025-11-17

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

Sex
ALL
Min age
18 Years
Max age
60 Years
Healthy volunteers
No
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)

Trial sites (47)

FacilityCityRegionStatus
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 Italy

Other trials for the same condition

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 Italy