This clinical trial is focused on studying a condition known as nonrelapsing secondary progressive multiple sclerosis, a type of multiple sclerosis where the disease progresses without relapses. The study will evaluate the effectiveness and safety of a treatment called Frexalimab, which is administered as a solution for injection. Participants in the study will receive either Frexalimab or a placebo, which is a substance with no active medication.
The purpose of the study is to determine if Frexalimab can help delay the progression of disability in individuals with this type of multiple sclerosis. Participants will be randomly assigned to receive either Frexalimab or a placebo, and neither the participants nor the researchers will know who is receiving which treatment. This is known as a double-blind study. The treatment will be given through an intravenous infusion, which means it will be delivered directly into a vein.
Throughout the study, participants will be monitored for changes in their condition, including any new or enlarging lesions in the brain as detected by MRI scans, changes in brain volume, and cognitive function. The study will also track any side effects or adverse events that may occur. The trial aims to provide valuable information on whether Frexalimab can be a beneficial treatment option for those with nonrelapsing secondary progressive multiple sclerosis.
1joining the study
Upon joining the study, the participant will be randomly assigned to receive either frexalimab or a placebo. This process is double-blind, meaning neither the participant nor the researchers will know which treatment is being administered.
The study is designed to assess the effectiveness and safety of frexalimab in adults with nonrelapsing secondary progressive multiple sclerosis.
2treatment administration
The treatment involves receiving frexalimab or a placebo through an intravenous infusion. This is a method where the solution is injected directly into a vein.
The frequency and dosage of the infusion will be determined by the study protocol and will be administered by healthcare professionals.
3monitoring and assessments
Participants will undergo regular monitoring to assess the progression of disability and any changes in their condition. This includes measuring the time to onset of confirmed disability progression over 3 and 6 months.
Additional assessments will include MRI scans to detect new or enlarging lesions, changes in brain volume, and cognitive function tests.
4evaluation of treatment effects
The study will evaluate the impact of the treatment on various health indicators, such as the annualized relapse rate, changes in fatigue levels, and patient-reported outcomes.
Blood tests will be conducted to monitor antidrug antibodies, serum immunoglobulin levels, and plasma neurofilament light chain levels.
5safety monitoring
Throughout the study, participants will be monitored for any adverse events, serious adverse events, and any other significant changes in health status.
Regular checks will be performed on laboratory tests, electrocardiograms (ECG), and vital signs to ensure participant safety.
6study duration
The estimated end date for the study is March 24, 2028. Participants will be involved in the study for the duration specified in the study protocol, which includes the double-blind treatment period and follow-up assessments.
Who Can Join the Study?
The participant must have been previously diagnosed with RRMS (Relapsing-Remitting Multiple Sclerosis) according to specific guidelines from 2017.
The participant must currently have SPMS (Secondary Progressive Multiple Sclerosis) as per criteria updated in 2013.
The participant must show documented evidence of worsening disability over the past 12 months before joining the study. This will be reviewed by a special committee.
The participant must not have had any new attacks or relapses of their condition for at least 24 months.
The participant must have an EDSS (Expanded Disability Status Scale) score between 3.0 and 6.5 points when screened for the study. This score measures the level of disability.
Men and women must use birth control methods that follow local rules for those taking part in clinical studies.
If the participant is eligible for treatment with siponimod (a medication for multiple sclerosis), they must either not tolerate it due to side effects or safety concerns, have found it ineffective, or have chosen not to use it.
Who Cannot Join the Study?
Patients who have other serious health conditions that could interfere with the study.
Patients who are pregnant or breastfeeding.
Patients who have had a recent infection or illness that could affect the study results.
Patients who are currently participating in another clinical trial.
Patients who have a history of allergic reactions to similar medications.
Patients who are unable to follow the study procedures or attend study visits.
Patients who have used certain medications recently that could interfere with the study.
Patients with a history of substance abuse or alcohol dependency.
Patients who have had a recent vaccination that could affect the study.
Patients with certain mental health conditions that could interfere with the study.
Frexalimab is a medication being studied for its potential to help people with nonrelapsing secondary progressive multiple sclerosis (nrSPMS). The goal of this medication is to slow down the progression of disability in patients with this condition.
Multiple Sclerosis – Multiple sclerosis is a chronic disease that affects the central nervous system, particularly the brain and spinal cord. It occurs when the immune system mistakenly attacks the protective sheath (myelin) that covers nerve fibers, leading to communication problems between the brain and the rest of the body. Over time, the disease can cause permanent damage or deterioration of the nerves themselves. Symptoms vary widely and can include fatigue, difficulty walking, numbness or tingling, muscle weakness, and problems with coordination and balance. The progression of the disease can be unpredictable, with periods of remission and relapse. The severity and specific symptoms can differ greatly from person to person.
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