A Study to Evaluate RO7204239 in Participants With Facioscapulohumeral Muscular Dystrophy

To join this study, you must be an adult between 18 and 65 years old and have a confirmed diagnosis of FSHD (either type 1 or type 2), with symptoms that match the condition. You need to be able to walk without help and your FSHD should be within a certain range of severity. It's also important that you agree to keep your physiotherapy, occupational therapy, and other exercise routines the same throughout the study.

There are some reasons why you might not be able to join. For example, if you are pregnant, breastfeeding, or planning to become pregnant within 17 months after the study ends. You also can't have been treated with similar myostatin-targeting medications before, or with any other experimental medications in the last 90 days (or longer, depending on the medication). If you have certain medical conditions like serious heart problems, allergies to the study drug, or some types of cancer, you won't be able to take part.

Additionally, if you have any conditions that would make MRI scans unsafe, or issues with your skin where injections might be given, you wouldn't be eligible. Recent injuries or surgeries that could affect how your movement is assessed would also prevent you from joining, as would any planned surgery that might impact your motor function during the study.

If you decide to take part in this study, you will either receive the new medication RO7204239 or a placebo (a treatment that looks like the medication but has no active ingredients). This is decided randomly, meaning you won't know which one you're getting, and neither will the study team. You will have regular visits to the study clinic for check-ups, assessments, and to receive your medication.

During these visits, the study team will perform various tests. These include physical examinations, blood tests, assessments of your muscle strength and movement, and potentially MRI scans. They will also ask you about any side effects you might be experiencing. The medication will likely be given as an injection under the skin. You'll need to continue your usual physiotherapy and exercise routines, but it's important not to change the frequency or intensity while you're in the study.

The total duration of your participation in the study, including follow-up appointments after your last dose of medication, will be explained by the study team. It's a commitment to regular visits and assessments over an extended period.