Ongoing Clinical Trials for Autoimmune Demyelinating Disease
Currently, there is one ongoing clinical trial investigating treatment options for autoimmune demyelinating disease, specifically focusing on Myelin Oligodendrocyte Glycoprotein Antibody-Associated Disease (MOGAD). This trial is being conducted across multiple European countries and is testing a medication called satralizumab to evaluate its effectiveness in preventing disease relapses.
Clinical trial locations
- France
- Germany
- Italy
- Poland
Study on the Effects of Satralizumab for Patients with Myelin Oligodendrocyte Glycoprotein Antibody-Associated Disease (MOGAD)
This clinical trial focuses on Myelin Oligodendrocyte Glycoprotein Antibody-Associated Disease, also known as MOGAD. This is a rare autoimmune disorder where the body’s immune system mistakenly attacks the protective covering of nerve fibers in the central nervous system. The condition can affect the brain, spinal cord, and optic nerves, leading to vision problems, muscle weakness, and sensory disturbances.
Main inclusion criteria:
- Participants must be at least 12 years old
- Must have a confirmed diagnosis of MOGAD with at least one relapse in the past 12 months or two attacks in the past 24 months
- Disability level measured by the Expanded Disability Status Scale (EDSS) must be between 0 and 6.5, indicating mild to moderate disability
- Vision must be better than 20/800 in each eye
- Participants may be either not receiving any ongoing immunosuppressant treatment or currently taking specific medications such as azathioprine, mycophenolate mofetil, or oral corticosteroids
- Women of childbearing age must agree to use adequate contraception during the study and for at least 3 months after the last dose
Main exclusion criteria:
- History of severe allergic reactions to the study medication or its ingredients
- Currently participating in another clinical trial
- Pregnancy or breastfeeding
- Recent treatment with certain medications that could interfere with study results
- History of substance abuse or addiction
- Unable to comply with study procedures or follow-up visits
- History of certain infections or compromised immune system
- Recent vaccination with a live vaccine
Study focus and goals:
The trial is testing a medication called satralizumab, which is administered as an injection under the skin. Satralizumab is a monoclonal antibody that works by targeting and blocking the interleukin-6 receptor, which plays a role in the inflammatory process associated with MOGAD. The main goal is to determine whether satralizumab can help prevent disease relapses and improve quality of life for people with this condition.
The study uses a double-blind design, meaning neither participants nor researchers know who is receiving the actual medication versus a placebo. Participants receive injections of either 120 mg of satralizumab or placebo according to a specific schedule. Throughout the study, participants undergo regular monitoring including MRI scans to check for active lesions, cognitive tests, and various health assessments. The primary focus is on measuring the time it takes for the first relapse to occur after starting treatment.
Investigational drug:
Satralizumab is the medication being tested in this trial. It is given as a subcutaneous injection, typically in the upper arm, thigh, or abdomen. This medication is designed to modulate the immune system’s response by inhibiting the interleukin-6 receptor. The study aims to evaluate how well satralizumab works when used alone or in combination with other treatments that participants may already be taking, as well as to assess its safety profile.
The trial is expected to continue until December 2027, allowing researchers to gather comprehensive data on the treatment’s long-term effectiveness and safety.
Summary
Currently, there is one active clinical trial focused on autoimmune demyelinating disease, specifically MOGAD. This trial is being conducted across four European countries: Poland, Germany, France, and Italy, providing opportunities for patients in these regions to participate. The study is investigating satralizumab, a monoclonal antibody that targets the inflammatory process associated with the condition. The trial’s design allows for evaluation of the medication both as a standalone treatment and in combination with existing immunosuppressant therapies, which may provide valuable information about different treatment approaches for this rare condition.