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A Study to Evaluate the Pharmacodynamics, Safety, Tolerability, Pharmacokinetics, and Efficacy of RO7204239 in Participants with Facioscapulohumeral Muscular Dystrophy
EU CTIS ID: 2022-503117-36-00
What this study is testing
To evaluate the pharmacodynamic (PD) effects of RO7204239 compared with placebo, using magnetic resonance imaging (MRI) and to evaluate the safety of RO7204239 compared with placebo
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 1. Age ≥ 18 and ≤ 65 years at the time of signing the Informed Consent Form
- 2. Genetic confirmation of FSHD1 or FSHD2
- 3. Clinical findings consistent with FSHD according to the investigator’s clinical judgment
- 4. Ability to walk unassisted 10 meters (Timed 10-Meter Walk Test [10MWT])
- 5. Ricci Clinical Severity Scale score ≥ 2.5 and ≤ 4
- 6. Agreement to maintain the same frequency and intensity of physiotherapy, occupational therapy, and other forms of exercise during the clinical study
You likely can't join if
- 1. Pregnancy or breastfeeding, or intention of becoming pregnant during the study or within 17 months after the final dose of RO7204239
- 2. Current or previous treatment (or receipt) of anti-myostatin therapies
- 3. Treatment with any investigational therapy within 90 days prior to screening, or 5 drug-elimination half-lives of the drug, whichever is longer
- 4. Contraindications to MRI scans, difficulties maintaining a prolonged supine position, or any other clinical history or examination finding that would pose a potential hazard in combination with MRI
- 5. Presence of clinically significant ECG abnormalities from average of triplicate measurement at screening indicating a safety risk for participants
- 6. Presence of clinically significant cardiovascular disease indicating a safety risk for participants. •Presence of clinically significant abnormal findings in echocardiography at screening, with the exception of mitral valve prolapse, which does not exclude participants from the study
The study team makes the final eligibility decision.
Where it's taking place
- United States
- United Kingdom
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include United States; United Kingdom. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.