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).

NCT05975905 ↗

Phase 2 Terminated 113 enrolled Keros Therapeutics, Inc.
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

EvaluationDrugModalityDoseRoute
Subject KER-012 Protein / enzyme biologic — Subcutaneous