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

Running, not enrolling · Phase 2 · Has a placebo group

Conditions studied: Relapsing Multiple Sclerosis

In brief

This study aims to examine the efficacy and safety of obexelimab in participants with relapsing multiple sclerosis

Key facts

Study ID

NCT06564311

Run by

Zenas BioPharma (USA), LLC

People needed

93

Starts

2024-08-26

Expected to finish

2026-02-01

Last updated by the study team

2025-11-17

Who can join

Age: 18 and older, up to 60. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• 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

Full record on ClinicalTrials.gov

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