Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT07038200 | A Study to Evaluate Del-brax (Also Referred to as AOC 1020) in Participants With FSHD | PHASE3 | RECRUITING | 200 | — | — | Jun 10, 2025 | Jul 1, 2028 | May 29, 2026 | 46 | United States, Canada +8 |
| Arm | Type | Description |
|---|---|---|
| del-brax | EXPERIMENTAL | Del-brax (AOC 1020) will be administered 13 times |
| placebo | PLACEBO_COMPARATOR | Saline will be administered 13 times |
| Name | Type | Description |
|---|---|---|
| AOC-1020 | DRUG | Placebo |
| Placebo | DRUG | Placebo will be administered by intravenous (IV) infusion. |
Inclusion Criteria: * Clinical and genetic diagnosis of FSHD1 or FSHD2 * Ability to walk independently at pre-specified walking speed (orthoses and ankle braces allowed) for at least 10 meters at screening * Adequate muscle strength based on QMT composite score Exclusion Criteria: * Breastfeeding...