Researchers seek participants to test drug safety

October 14, 2022
Researchers seek participants for a clinical trial to test the safety of a new drug at different dose levels in people living with multiple sclerosis; determine how well it is tolerated by participants; measure how the body absorbs, distributes, and gets rid of it; and find out what effects, good or bad, the drug has on participants.

The study drug is being developed by Genentech for the possible treatment of MS. The study drug combines an antibody with a “brain shuttle” module, which delivers it to the brain. The study drug attaches to B cells and reduces their number to stop your immune system from attacking the myelin around the nerve cells. Because B cells are also found in the brain, attaching the antibody to the “brain shuttle” will allow researchers to decrease this B-cell population.

This clinical trial is a phase 1 study recruiting people who have MS, but have not experienced a relapse or new MRI activity for 12 months. People with relapsing and progressive are eligible.

If you are eligible, participants will be given one dose of the study drug. After doing some tests to confirm suitability for the trial, participants will come into the clinical trial unit for the study drug administration and stay for two nights so their health can be monitored. After leaving the clinical unit on the third day, there will be at least 10 outpatient hospital visits. These hospital visits will include checks to see how participants respond to the treatment and any side effects they may have. In total, the time commitment is approximately 24 weeks. Participants are free to leave the clinical trial at any time.

The main clinical trial endpoints are:
  • Side effects: how often, how bad they are, and why they might have occurred
  • Blood and urine results: reviewing trends in certain tests to see if the study drug is causing changes in your body
  • Vital signs and electrocardiogram: reviewing trends in changes after the Study Drug has been taken.
  • Changes in suicide risk

The other clinical trial endpoints are measuring how the body absorbs, distributes, and gets rid of the study drug in blood and spinal fluid; and finding out what effects, good or bad, the study drug has on trial participants.

You can participate in this trial if you:
  • Are 18 to 65 years old.
  • Have not experienced a relapse or new MRI activity for 12 months.
  • Are still able to walk five meters or more with or without aid.
  • Are not on any therapy for controlling MS symptoms or are not planning on starting any MS therapy for the whole trial duration.

In this trial, six different dose levels, or “cohorts,” of the study drug are planned to be tested, one per cohort. Everyone who joins this clinical trial will be given a single dose of the study drug, as an intravenous infusion. After each cohort is complete, the test results will be reviewed. The next cohort will start at a higher dose level after the previous dose level has been shown to be safe and well tolerated in previous participants. In each cohort, only one participant will receive the study drug at first. If this is assessed to be safe, and at least 36 hours have gone by since the first participant in this dose group has received the study drug, the remaining participants of the same dose group will receive the study drug.

The safety or effectiveness of the study drug is not known at the time of the trial. Most trials involve some risks to the participant, although it is not known how these risks compare to the risks related to routine medical care or the natural progression of the health condition. You will be told about any risks and benefits of taking part in the clinical trial, as well as any additional procedures, tests, or assessments you will be asked to undergo. These will be described in an informed consent document that provides people with the information they need to make a decision to volunteer for a clinical trial. Potential participants should also discuss these with members of the research team, with their usual healthcare provider and their support group. Anyone interested in taking part in a clinical trial should know as much as possible about the trial and feel comfortable asking the research team any questions about the trial.

The study drug has not yet been tested in humans. For this reason, the side effects of this drug are not known at this time. Side effects can be mild to severe and life threatening, and can vary from person to person. You will be told about the potential side effects, based on laboratory studies or knowledge of similar drugs.

There is no guarantee you will receive any benefits from this study and taking part in this study may or may not cause your health to improve. Investigational therapies are treatments that have not yet been proven to be beneficial but are being investigated as part of a research study. Because this is an investigational therapy being used in a dose-ranging first-in-human trial, you will receive a dose that is not expected to have much, if any, effectiveness on treating or preventing progression of your disease. Information from this study may help doctors learn more about the Study Drug and the treatment of MS. This information may benefit other patients with MS or a similar condition in the future.

To learn more, visit our website.

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