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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05975905 | A Study to Investigate the Safety and Efficacy of KER-012 in Combination With Background Therapy in Adult Participants With Pulmonary Arterial Hypertension (PAH) (TROPOS Study). | PHASE2 | COMPLETED | 113 | — | — | Oct 17, 2023 | Mar 11, 2025 | Sep 30, 2025 | 55 | United States, Australia +9 |
Evaluate the effect of KER-012 on pulmonary hemodynamics compared to Placebo in participants on background pulmonary arterial hypertension (PAH) therapy
| Arm | Type | Description |
|---|---|---|
| Arm 1 | EXPERIMENTAL | KER-012 (Dose A) subcutaneously (SC) (every 4 weeks \[Q4W\]) Treatment Period: Dose A for 24 weeks; Extension Period: Dose A for another 72 weeks |
| Arm 2 | EXPERIMENTAL | KER-012 (Dose B) SC (Q4W) Treatment Period: Dose B for 24 weeks; Extension Period: Dose B for another 72 weeks |
| Arm 3 | EXPERIMENTAL | KER-012 (Dose C) SC (Q4W) Treatment Period: Dose C for 24 weeks; Extension Period: Dose C for another 72 weeks |
| Arm 4 | PLACEBO_COMPARATOR | Treatment Period: Placebo for 24 weeks; Extension Period: Dose B for another 72 weeks |
| Name | Type | Description |
|---|---|---|
| Dose A KER-012 | BIOLOGICAL | Dose A KER-012 (Q4W); |
| Dose B KER-012 | BIOLOGICAL | Dose B KER-012 (Q4W); |
| Dose C KER-012 | BIOLOGICAL | Dose C KER-012 (Q4W); |
| Placebo for 24 Weeks followed by Dose B KER-012 for 72 weeks | BIOLOGICAL | Treatment Period (24 weeks): Placebo SC (Q4W) Extension Period (72 weeks after Placebo treatment): KER-012 (Dose B) SC (Q4W) |
Inclusion Criteria: * Adult participants ≥ 18 years of age * Symptomatic World Health Organization (WHO) Group 1 Pulmonary Hypertension (PH)(PAH) classified by one of the following subgroups: * Idiopathic pulmonary arterial hypertension (IPAH); * Heritable pulmonary arterial hypertension (HPAH...