Are you interested in possibly taking part in the OPTIMA Clinical Trial?

See if you may be eligible

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.

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.

What drugs are being investigated?

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.

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 A:

Dose A of the trial drug

Group B:

Dose B of the trial drug

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.

How long is this trial?

The total duration of the trial is about 2 years and will involve about 18 visits, including an end of trial visit/phone call.

What will the trial involve?

If you join the OPTIMA Clinical Trial, you will need to have frequent trial visits. During the clinical trial, in addition to receiving the treatment, your health will be regularly checked during visits. Which assessments and procedures that occur will vary

between visits but will include for example, blood tests, physical examinations, CT scans, and quality of life questionnaires. If you take part in this trial, you will be given a detailed Visit Guide that explains exactly what will happen at each visit.

What if I no longer want to participate in this clinical trial?

Taking part in the OPTIMA Clinical Trial is entirely voluntary. You do not need to give any reason to leave this clinical trial or withdraw your consent at any time.

How can I take part in this Trial?

If you wish to take part in the OPTIMA Clinical Trial, you can fill in the pre-screener questionnaire to see if you may be eligible to participate:

Find a clinical trial site near you

To find out more about OPTIMA, and whether it may be right for you, please contact the OPTIMA Clinical Trial team at a clinical trial site near you – they will be more than happy to help.

Find your nearest clinical trial site.