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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05432466 | Clinical Trial to Compare the Efficacy of Celiprolol to Placebo in Patients With Vascular Ehlers-Danlos Syndrome | PHASE3 | RECRUITING | 150 | — | — | Nov 7, 2022 | Apr 1, 2029 | Aug 24, 2025 | 1 | United States |
| Arm | Type | Description |
|---|---|---|
| ACER-002 (celiprolol) 200 mg BID | EXPERIMENTAL | ACER-002 200 mg twice daily (BID) (after titration): 200 mg morning and 200 mg evening: 400 mg total daily dose Titration: Day 1 to Month 1 - 100 mg once daily (QD) evening: 100 mg total daily dose Month 2 to Month 3 - 100 mg morning and 100 mg evening: 200 mg total daily dose Month 3 to Month 4 - 100 mg morning and 200 mg evening: 300 mg total daily dose Month 4 to End of Treatment Period (BID) - 200 mg morning and 200 mg evening: 400 mg total daily dose |
| Placebo BID | EXPERIMENTAL | Placebo twice daily (BID) Placebo given orally to mimic ACER-002 (celiprolol) administration |
| Name | Type | Description |
|---|---|---|
| ACER-002 (celiprolol) 200 mg BID | DRUG | ACER-002 (celiprolol) 200 mg BID |
| Placebo BID | DRUG | placebo for ACER-002 |
Inclusion Criteria: 1. Willingness to obtain magnetic resonance angiogram (MRA) image at local imaging facility. 2. A genetic test confirming the presence of a pathogenic COL3A1 variant (classified as likely pathogenic or pathogenic according to ACMG/AMP Guidelines. 3. Patients must be ≥ 15 years o...