Welcome to the OPTIMA Clinical Trial

For people with fibrodysplasia ossificans progressiva

Welcome!

This website provides information about a clinical trial, the OPTIMA Clinical Trial, for people with fibrodysplasia ossificans progressiva, or FOP.

Clinical trials are essential to developing treatments – we wouldn’t be able to develop treatments without volunteers like you. Everyone involved in this clinical trial plays an important role in increasing our understanding of FOP, which may help other patients in the future with this condition.

Why are we doing this clinical trial?

FOP is an extremely rare genetic disease characterised by abnormal bone growth in areas of the body where bone is normally not present (called heterotopic ossification), such as the ligaments, tendons, and skeletal muscles. People with FOP may also experience “flare-ups” that are unpredictable episodes of soft tissue swelling, pain, stiffness, and reduced movement. Flare-ups may sometimes lead to additional bone formation.

The OPTIMA Clinical Trial is testing an investigational 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.

In this clinical trial, researchers want to find out if the investigational drug can help reduce signs and symptoms of FOP, such as the number of flare-ups and amount of abnormal bone growth.

How is the investigational drug believed to work?

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.

Who can take part in the OPTIMA Clinical Trial?

You may be eligible to take part if you are:

18 years old or older

Diagnosed with FOP

Experiencing signs and symptoms associated with FOP flare-ups (such as pain, swelling, or stiffness) in the last year

There are other requirements to participate.

If you are interested in participating in the OPTIMA Clinical Trial, please fill in this questionnaire to see if you may be eligible.

What else should I know?

Participating in a clinical trial is always voluntary, meaning that you can stop at any time without consequences to your usual medical care. There is no guarantee that you will receive a medical benefit from taking part in this clinical trial. Your condition may get better, stay the same, or may get worse. The trial drug may also cause side effects or affect your health in an unknown way. However, your safety is our top priority and your health will be closely monitored throughout the OPTIMA Clinical Trial.

Participants in clinical trials are essential to developing treatments and increasing our medical understanding of rare diseases, such as FOP. The information we gather from this clinical trial may benefit other patients in the future like you.

If you think you may be interested in taking part, or would like more information, please contact your local OPTIMA Clinical Trial team – they will be more than happy to help.

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