A Study to Evaluate Del-brax (Also Referred to as AOC 1020) in Participants With FSHD

Change from Baseline to Week 78 in 10MWRT

Assessment of the time required to walk or run 10 meters as quickly and safely as possible

Time frame: Baseline through Week 78

Change from Baseline to Week 78 in Timed Up-and-Go (TUG)

Assessment of functional mobility by measuring the time required to stand up from a chair, walk 3 meters, turn, return, and sit down

Time frame: Baseline through Week 78

Change from Baseline to Week 78 in Patient-Reported Outcomes Measurement Information System (PROMIS) Physical Function Item Bank v2.0-Physical Function-Short Form 20a Questionnaire

Assessment of patient-reported physical function using the PROMIS Physical Function Short Form 20a questionnaire

Time frame: Baseline through Week 78

Change from Baseline to Week 78 in PROMIS Fatigue

Assessment of patient-reported fatigue using the PROMIS Fatigue questionnaire

Time frame: Baseline through Week 78

Change from Baseline to Week 78 in Worst Pain Numeric Rating Scale (NRS)

Assessment of the severity and impact of fatigue over the previous 7 days using the self-reported PROMIS Fatigue Short Form 6a questionnaire

Time frame: Baseline through Week 78

Change from Baseline to Week 78 in Patient Global Impression of Severity/Change (PGI-S/PGI-C)

Assessment of participant-reported disease severity and change in disease status using the Patient Global Impression of Severity/Change (PGI-S/PGI-C) scales

Time frame: Baseline through Week 78

Change from Baseline to Week 78 in Quality of Life in Neurological Disorders (NeuroQoL) Upper Extremity Function

Assessment of health-related quality of life using the Quality of Life in Neurological Disorders (Neuro-QoL) questionnaire

Time frame: Baseline through Week 78

Change from Baseline to Week 78 in NeuroQoL Sleep Disturbance

Assessment of participant-reported sleep disturbance using the Neuro-QoL Sleep Disturbance questionnaire

Time frame: Baseline through Week 78

Change from Baseline to Week 78 in DUX4-regulated plasma KHDC1L

Assess of changes from baseline in circulating PD biomarkers relevant to FSHD

Time frame: Baseline through Week 78

Change from Baseline to Week 78 in Serum CK

Assess of changes from baseline in circulating PD biomarkers relevant to FSHD

Time frame: Baseline through Week 78