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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT06066580 | Open-Label Extension of EDG-5506 in Participants With Becker Muscular Dystrophy | PHASE2 | ENROLLING BY_INVITATION | 260 | — | — | Nov 2, 2023 | Feb 1, 2031 | May 6, 2026 | 46 | United States, Belgium +8 |
| NCT05291091 | Phase 2 Study of EDG-5506 in Becker Muscular Dystrophy (GRAND CANYON) | PHASE2 | ACTIVE NOT_RECRUITING | 244 | — | — | Nov 10, 2022 | Sep 1, 2026 | May 20, 2026 | 51 | United States, Australia +10 |
| NCT05160415 | A Study of EDG-5506 in Adult Males With Becker Muscular Dystrophy | PHASE1 | COMPLETED | 12 | — | — | Dec 28, 2021 | Mar 1, 2024 | Jun 24, 2025 | 1 | United States |
All participants
All participants
Adult participants
Adult participants
An AE is any untoward medical occurrence in a patient administered a medicinal product. The AE does not necessarily have to have a causal relationship with the study drug. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. The numerator of the percentage is the number of participants experiencing at least one AE after first dose of study drug up to 25 months.
An AE is any untoward medical occurrence in a patient administered a medicinal product. The AE does not necessarily have to have a causal relationship with the study drug. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. The endpoint is the cumulative total number of AEs occurring after first dose of study drug up to 25 months among participants who received at least one dose of study drug.
An AE is any untoward medical occurrence in a patient administered a medicinal product. The AE does not necessarily have to have a causal relationship with the study drug. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. The severity of an AE is graded, according to the study protocol definitions of AE severity/intensity, as "mild", "moderate" or "severe". Participants who reported multiple AEs are counted only once at the highest severity reported.
| Arm | Type | Description |
|---|---|---|
| Treatment | EXPERIMENTAL | Drug: Sevasemten |
| Adult Cohort 1 | EXPERIMENTAL | Drug: Sevasemten Drug: Placebo |
| Adult Cohort 2 | EXPERIMENTAL | Drug: Sevasemten Drug: Placebo |
| Adult Cohort 6 | EXPERIMENTAL | Drug: Sevasemten Drug: Placebo |
| Adolescent Cohort 4 | EXPERIMENTAL | Drug: Sevasemten Drug: Placebo |
| Adolescent Cohort 5 | EXPERIMENTAL | Drug: Sevasemten Drug: Placebo |
| Name | Type | Description |
|---|---|---|
| Sevasemten | DRUG | Sevasemten is administered orally once per day |
| Sevasemten 10 mg | DRUG | Sevasemten is administered orally once per day |
| Sevasemten 5 mg | DRUG | Sevasemten is administered orally once per day |
| Sevasemten 12.5 mg | DRUG | Sevasemten is administered orally once per day |
| Placebo | DRUG | Placebo is administered orally once per day |
Key Inclusion Criteria: 1\. Males with a diagnosis of BMD and participation in EDG-5506-002 ARCH, EDG-5506-201 CANYON and GRAND CANYON, or EDG-5506-202 DUNE. Participants are eligible if they complete the respective prior study visits as follows: * EDG-5506-002 ARCH: Complete the final study Visit...