ACTIVE_NOT_RECRUITING

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

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Conditions

Relapsing Multiple SclerosisRMSMSMultiple Sclerosis

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Official Title

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

Quick Facts

Study Start:2024-08-26
Study Completion:2026-02
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT06564311

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.

Ages Eligible for Study:18 Years to 60 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Diagnosis of RMS (relapsing-remitting or secondary progressive with relapses) according to the 2017 revision of the McDonald diagnostic criteria
  2. 2. An EDSS of ≤ 5.5 at the Screening Visit
  3. 3. Must have documentation of:
  4. 1. . at least 1 relapse within the previous year OR
  5. 2. . ≥ 2 relapses within the past 2 years OR
  6. 3. . ≥ 1 active Gd-enhancing brain lesion on an MRI scan within the past 6 months prior to screening
  7. 4. Not of childbearing potential or willing to follow contraceptive guidance
  1. 1. Primary progressive MS or secondary progressive MS without relapses
  2. 2. Meet criteria for neuromyelitis optica spectrum disorder
  3. 3. Relapse in the 30 days prior to randomization
  4. 4. ≥ 10 years disease duration from onset with patient's EDSS ≤ 2.0 (patient reported is adequate in absence of written medical record)
  5. 5. Has \> 20 Gd+ lesions on brain MRI at screening

Contacts and Locations

Study Locations (Sites)

North Central Neurology
Cullman, Alabama, 35058
United States
Center for Neurology and Spine
Phoenix, Arizona, 85032
United States
Perseverance Research Center
Scottsdale, Arizona, 85253
United States
Regina Berkovich MD PhD, Inc
West Hollywood, California, 90048
United States
Aqualine Clinical Research
Naples, Florida, 35105
United States
University of South Florida
Tampa, Florida, 33620
United States
University of Massachusetts Medical School
Worcester, Massachusetts, 01655
United States
Infusion Associates Plymouth
Plymouth, Minnesota, 55446
United States
MS Center for Innovations in Care
Saint Louis, Missouri, 63131
United States
Holy Name Medical Center
Teaneck, New Jersey, 07666
United States
Boster Center for MS
Columbus, Ohio, 43235
United States
North Texas Institute of Neurology and Headache
Plano, Texas, 75024
United States
Center for Neurological Disorders
Greenfield, Wisconsin, 53228
United States
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
United States

Collaborators and Investigators

Sponsor: Zenas BioPharma (USA), LLC

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-08-26
Study Completion Date2026-02

Study Record Updates

Study Start Date2024-08-26
Study Completion Date2026-02

Terms related to this study

Keywords Provided by Researchers

  • Relapsing Multiple Sclerosis
  • RMS
  • MS
  • Multiple Sclerosis

Additional Relevant MeSH Terms

  • Relapsing Multiple Sclerosis