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

Description

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

Conditions

Relapsing Multiple Sclerosis

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Study Overview

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Study Details

Study overview

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

A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Obexelimab in Patients With Relapsing Multiple Sclerosis

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

Condition
Relapsing Multiple Sclerosis
Intervention / Treatment

-

Contacts and Locations

West Hollywood

Regina Berkovich MD PhD, Inc, West Hollywood, California, United States, 90048

Naples

Aqualine Clinical Research, Naples, Florida, United States, 35105

Ozark

Sharlin Health Neuroscience Research, Ozark, Missouri, United States, 65721

Saint Louis

MS Center for Innovations in Care, Saint Louis, Missouri, United States, 63131

Teaneck

Holy Name Medical Center, Teaneck, New Jersey, United States, 07666

Columbus

Boster Center for MS, Columbus, Ohio, United States, 43235

Plano

North Texas Institute of Neurology and Headache, Plano, Texas, United States, 75024

Vienna

MS Center of Greater Washington, Vienna, Virginia, United States, 22182

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • 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

Ages Eligible for Study

18 Years to 60 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Zenas BioPharma (USA), LLC,

Study Record Dates

2025-12