drugset / Trial / 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).
RandomizedParallel-groupQuadruple-blindTreatment
Summary
Study KER-012-A201 is Phase 2, double-blind, randomized, placebo-controlled study to determine the efficacy and safety of KER-012 compared to Placebo in adults with PAH (WHO Group 1 PH) on stable background PAH therapy. The study is divided into the Screening Period, Treatment Period, Extension Period, and Follow-Up Period.
Timeline
- Start
- 2023-10-17
- Primary completion
- 2025-03-05
- Completion
- 2025-03-11
Outcome
Outcome not reported
Stopped: “The study was voluntarily terminated early, following a safety review and observation of pericardial effusions.”
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | KER-012 | Protein / enzyme biologic | — | Subcutaneous |