About the trial drug
The OPTIMA Clinical Trial is testing an investigational drug (trial drug) as a potential treatment in people with FOP. The drug being tested is called “investigational” because it hasn’t been approved for use outside of this clinical trial.
The investigational drug is a type of drug called a monoclonal antibody. Antibodies are proteins naturally found in your blood that help fight infections. Monoclonal antibodies are modified antibodies developed to target specific proteins in your body. The investigational drug is believed to block a protein called Activin A that is known to trigger abnormal bone growth in people with FOP.
What trial treatment will I receive?
You will receive either the investigational drug or a placebo.
A placebo is a substance that looks like the trial drug but does not contain any real medicine. Placebos are essential to clinical trials as they help us test how effective an investigational drug may be.
The trial drug or placebo will be given to you through an 1-hour intravenous (IV) infusion into the vein in your arm.
You will have a 2 in 3 (66%) chance of receiving the trial drug. Participants will be randomly assigned to 1 of 3 treatment groups:
Group B:
Group C:
Placebo
This trial is “double-blind” – meaning neither you nor your trial doctor or trial team will know which treatment you are receiving. However, if necessary for a significant medical event or medical emergency, the trial doctor or trial team can find out which group you are in.
What are potential risks to participation?
As with all medications, there are possible risks when taking investigational drugs. It is also possible that you may experience other changes to your health. This includes allergic reactions, as well as risks to male fertility and pregnancy. You will receive an Informed Consent Form before you join the clinical trial
that provides additional information on known risks and benefits of taking part in OPTIMA.
Throughout the clinical trial, your trial doctor will be monitoring your health and safety. They are always available to answer your questions or address concerns.
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