NCT lookup

Pull any trial record directly from ClinicalTrials.gov.

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

NCT06564311

Active Not RecruitingPhase 2

Sponsor: Zenas BioPharma (USA), LLC

Conditions: Relapsing Multiple Sclerosis

Interventions: Obexelimab, Placebo

Countries: United States, Austria, Belgium, China, Croatia, Czechia, Denmark, Greece

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

Eligibility overview

Sex: ALL

Age: 18 Years to 60 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

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

Locations (47)

Cullman, Alabama, United States
Phoenix, Arizona, United States
Scottsdale, Arizona, United States
West Hollywood, California, United States
Naples, Florida, United States
Tampa, Florida, United States
Worcester, Massachusetts, United States
Plymouth, Minnesota, United States
St Louis, Missouri, United States
Teaneck, New Jersey, United States
Columbus, Ohio, United States
Plano, Texas, United States
Greenfield, Wisconsin, United States
Milwaukee, Wisconsin, United States
Vienna, Austria
Overpelt, Belgium
Roeselare, Belgium
Beijing, China
Suzhou, China
Tianjin, China
Ürümqi, China
Wuhan, China
Zagreb, Croatia
Brno, Czechia
Jihlava, Czechia
Prague, Czechia
Aalborg, Denmark
Chaïdári, Greece
Larissa, Greece
Cefalù, Italy
+ 17 more on CT.gov