A Study to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Satralizumab in Patients With Myelin Oligodendrocyte Glycoprotein Antibody-Associated Disease

Description

The main objective of the study is to evaluate the efficacy of satralizumab compared with placebo based on time from randomization to the first occurrence of an adjudicated MOGAD relapse in the double-blind (DB) treatment period

Conditions

Myelin Oligodendrocyte Glycoprotein Antibody-Associated Disease (MOGAD)

Study Overview

Study Details

Study overview

The main objective of the study is to evaluate the efficacy of satralizumab compared with placebo based on time from randomization to the first occurrence of an adjudicated MOGAD relapse in the double-blind (DB) treatment period

A Phase III, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study To Evaluate The Efficacy, Safety, Pharmacokinetics, And Pharmacodynamics Of Satralizumab As Monotherapy Or In Addition To Baseline Therapy In Patients With Myelin Oligodendrocyte Glycoprotein Antibody-Associated Disease (MOGAD)

A Study to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Satralizumab in Patients With Myelin Oligodendrocyte Glycoprotein Antibody-Associated Disease

Condition
Myelin Oligodendrocyte Glycoprotein Antibody-Associated Disease (MOGAD)
Intervention / Treatment

-

Contacts and Locations

Birmingham

University of Alabama at Birmingham, Birmingham, Alabama, United States, 35249

Scottsdale

Mayo Clinic- Scottsdale, Scottsdale, Arizona, United States, 85259

Orange

University of California Irvine - Manchester Pavilion, Orange, California, United States, 92868

Aurora

University of Colorado - Anschutz Medical Campus (University of Colorado Health Sciences Center), Aurora, Colorado, United States, 80045

Washington

Medstar Georgetown University Hospital, Washington, District of Columbia, United States, 20007

Gainesville

University of Florida College of Medicine Gainesville; Neurology, Gainesville, Florida, United States, 32608

Jacksonville

Nemours Children's Clinic - of the Nemours Foundation, Jacksonville, Florida, United States, 32207

Savannah

Meridian Clinical Research, LLC, Savannah, Georgia, United States, 31406

Chicago

Northwestern University, Chicago, Illinois, United States, 60611

Northbrook

Consultants in Neurology Ltd, Northbrook, Illinois, United States, 60062

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

    Ages Eligible for Study

    12 Years to

    Sexes Eligible for Study

    ALL

    Accepts Healthy Volunteers

    No

    Collaborators and Investigators

    Hoffmann-La Roche,

    Clinical Trials, STUDY_DIRECTOR, Hoffmann-La Roche

    Study Record Dates

    2028-12-31