Ongoing Clinical Trials for Demyelination
Currently, there is 1 ongoing clinical trial investigating treatments for demyelination, specifically focused on Myelin Oligodendrocyte Glycoprotein Antibody-Associated Disease (MOG-AD). This trial is testing rozanolixizumab, a medication designed to reduce the activity of antibodies that attack the nervous system, and is taking place across multiple European countries including Greece, Germany, Czechia, Poland, Belgium, France, Sweden, Italy, Portugal, and Spain.
Clinical trial locations
- Belgium
- Czechia
- France
- Germany
- Greece
- Italy
- Poland
- Portugal
- Spain
- Sweden
Study on the Effectiveness and Safety of Rozanolixizumab for Adults with Myelin Oligodendrocyte Glycoprotein Antibody-Associated Disease (MOG-AD)
This clinical trial is investigating rozanolixizumab, also known as UCB7665, as a potential treatment for adults living with Myelin Oligodendrocyte Glycoprotein Antibody-Associated Disease (MOG-AD). This is a rare neurological condition where the immune system mistakenly attacks a protein called myelin oligodendrocyte glycoprotein in the central nervous system, causing inflammation and damage. The disease can affect the optic nerves and spinal cord, leading to vision problems, muscle weakness, and sensory disturbances.
Who can participate: The study is open to adults between 18 and 89 years old who have a confirmed diagnosis of MOG-AD with a history of relapsing disease. Participants must have experienced at least one relapse in the last 12 months and have a positive test for MOG antibodies using a cell-based assay within 6 months before joining the trial. Additionally, participants need to be clinically stable at the time of screening, meaning their condition is not actively changing.
Who cannot participate: Individuals without a confirmed diagnosis of MOG-AD are not eligible for this study. The trial also excludes people outside the specified age range and those who are considered part of a vulnerable population requiring special protection or care.
Study focus and design: The main goal of the study is to evaluate how effective and safe rozanolixizumab is in preventing relapses in adults with MOG-AD. The trial uses a double-blind design, meaning neither participants nor researchers know who is receiving the actual medication or a placebo during the initial treatment period. This approach helps ensure unbiased results. Rozanolixizumab is given as an injection under the skin at a dose of 140 mg/ml.
The study measures several important outcomes, including the time it takes for participants to experience their first relapse after starting treatment, changes in visual acuity and disability levels, and the number of hospitalizations related to MOG-AD. Following the double-blind phase, participants have the opportunity to enter an open-label extension period where everyone receives rozanolixizumab. During this phase, researchers continue to monitor adverse events and the annual relapse rate.
Investigational drug: Rozanolixizumab is a monoclonal antibody currently in Phase 3 clinical trials. It works by targeting and reducing the activity of specific antibodies believed to contribute to the symptoms of MOG-AD. This medication is administered through subcutaneous injection and aims to help manage the immune system’s attack on the nervous system.
Summary
This single ongoing trial represents an important step in developing treatment options for MOG-AD, a rare form of demyelinating disease. The study is notably international in scope, taking place across ten European countries, which may help ensure diverse patient representation and faster enrollment. The trial focuses specifically on rozanolixizumab, a monoclonal antibody designed to reduce harmful antibody activity, and follows a rigorous double-blind design with an open-label extension period to assess both short-term and long-term safety and effectiveness. For patients living with MOG-AD who experience recurring relapses, this trial offers access to a potentially beneficial treatment while contributing to scientific understanding of this rare condition.