Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
REGN13335 · 2 trials · 2 indications
| Arm | Type | Description |
|---|---|---|
| DBTP-Arm1 | EXPERIMENTAL | - |
| DBTP-Arm2 | EXPERIMENTAL | - |
| DBTP-Arm3 | PLACEBO_COMPARATOR | - |
| OLE-Arm1 | EXPERIMENTAL | - |
| OLE-Arm2 | EXPERIMENTAL | - |
| IV Cohort 1 Low Dose | EXPERIMENTAL | Randomized as described in the protocol |
| IV Cohort 2 Mid Dose | EXPERIMENTAL | Randomized as described in the protocol |
| IV Cohort 3 High Dose | EXPERIMENTAL | Randomized as described in the protocol |
| IV Cohort 4 Higher Dose | EXPERIMENTAL | Randomized as described in the protocol |
| IV Cohort 5 Highest Dose | EXPERIMENTAL | Randomized as described in the protocol |
| SC Cohort 1 Low Dose | EXPERIMENTAL | Randomized as described in the protocol |
| SC Cohort 2 High Dose | EXPERIMENTAL | Randomized as described in the protocol |
| IV or SC Optional Cohort | EXPERIMENTAL | ≤ Highest IV or SC Dose as described in the protocol Randomized as described in the protocol |
| Name | Type | Description |
|---|---|---|
| REGN13335 | DRUG | Administered per the protocol |
| Placebo | DRUG | Administered per the protocol |
| Matching Placebo | DRUG | Administered IV or SC, sequential ascending single dose |
Key Inclusion Criteria: 1. Documented clinical diagnosis of PAH (Group 1 PH according to the 7th World Symposium on Pulmonary Hypertension (WSPH)) 2. WHO functional class II or III (slight to marked limitation of functional status due to PAH) 3. Receiving background Standard Of Care (SOC) therapy f...