The PATH-MS Clinical Study

Contents

What is the PATH-MS study?

PATH-MS is a global clinical study recruiting participants to test a potential new treatment for people living with multiple sclerosis, also known as MS.

MS is a long-term condition that affects the central nervous system, including the brain, spinal cord, and optic nerves. Symptoms can vary from person to person and may include problems with walking, balance, hand or arm function, vision, fatigue, thinking, and daily activities.

PATH-MS is studying an investigational medicine designed to target certain immune cells that may play a role in MS-related inflammation and nerve damage.

The goal of the PATH-MS study is to find out whether the investigational medicine can help slow disability progression and support everyday function in people living with MS. The study will also help researchers learn more about the safety of the investigational medicine and how it affects the body over time.

What could participation involve?

Participation in the study will last around 3 years from start to finish.

There are three main parts to the PATH-MS study:

Screening period

Tests and checks to see if you are able to take part in the study. These may include a review of your medical history, physical and neurological examinations, blood and urine tests, and MRI scans.

Treatment period

If you are eligible and decide to take part, you will receive the investigational medicine or placebo by intravenous infusion, also called an IV infusion. An IV infusion means the medicine is given slowly through a needle placed into a vein.

Your first dose may be given as two separate infusions about 2 weeks apart. After that, study infusions may take place about once every 6 months.

Safety follow-up

After your treatment period ends, you will have follow-up visits or checks so the study team can continue to monitor your health and safety.

If you are eligible to take part in the study, you will be randomly placed into one of the following groups:

  1. One group will receive placebo
  2. One group will receive the investigational medicine

A placebo is a “dummy” infusion that looks the same as the study drug but has no active medicine.

This study is double-blind, meaning neither you nor your study doctor will know which group you have been placed in during the main part of the study.

During treatment, you may:

  • Visit the clinic regularly for study assessments and safety checks
  • Have MRI scans to look for changes in the brain and spinal cord
  • Have neurological examinations to check MS symptoms and function
  • Complete walking, hand function, and coordination assessments
  • Complete thinking and processing-speed assessments
  • Answer questionnaires about fatigue, daily activities, quality of life, and how MS affects you
  • Have blood and urine tests to monitor your health
  • Be asked about any new or worsening symptoms, medications, or changes in your health

Some visits may take longer than others, especially infusion visits. On infusion days, you may need to stay at the clinic for several hours so the study team can give the infusion and monitor you afterward.

Is there a cost to participate?

There is no cost to take part in the study. Study-related care and procedures are provided at no charge.

Depending on the study and location, reimbursement for travel or other expenses may be available. The study team can explain this in more detail.

Find out if you are eligible to take part and get connected to a site near you

Thank you for your interest in the PATH-MS study.

Answer a few questions to see whether this study may be suitable for you.

Your answers will only be used to help assess whether this study may be appropriate for you and to support next steps, where applicable.

Talk to AXON team members at our booth to find out more about our approach to pre-screening.