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).

A Randomized, Phase 2, Double-blind, Placebo-controlled Study to Investigate the Safety and Efficacy of KER-012 in Combination With Background Therapy in Adult Participants With Pulmonary Arterial Hypertension (TROPOS Study)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 113 (actual)
• Sponsor: Keros Therapeutics, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This is a randomized, phase 2, double-blind, placebo-controlled study of KER-012 in combination with background therapy in participants with PAH of World Health Organization (WHO) Group 1, functional class II-III. Participants will be randomly assigned in a 2:2:2:3 ratio to receive KER-012 (Dose A), KER-012 (Dose B), KER-012 (Dose C), or placebo by subcutaneous injection (SC) every 4 weeks for a period of 24 weeks in the placebo-controlled treatment period of the study while on background therapy. Evaluations will include changes in pulmonary vascular resistance (PVR), 6-minute walk distance (6MWD), and safety parameters. Participants who have not discontinued early from the placebo-controlled treatment period and have had their post-treatment period PVR assessment will be able to continue into the 72-week extension period in which KER-012 treated participants will continue to receive their same assigned dose level from the treatment period every 4 weeks and placebo treated participants will receive KER-012 (Dose B) every 4 weeks while on background therapy.

Conditions

• Pulmonary Arterial Hypertension

Interventions

Type	Name	Description
BIOLOGICAL	Dose A KER-012	Dose A KER-012 (Q4W);
BIOLOGICAL	Dose B KER-012	Dose B KER-012 (Q4W);
BIOLOGICAL	Dose C KER-012	Dose C KER-012 (Q4W);
BIOLOGICAL	Placebo for 24 Weeks followed by Dose B KER-012 for 72 weeks	Treatment Period (24 weeks): Placebo SC (Q4W) Extension Period (72 weeks after Placebo treatment): KER-012 (Dose B) SC (Q4W)

Timeline

• Start date: 2023-10-17
• Primary completion: 2025-03-05
• Completion: 2025-03-11
• First posted: 2023-08-04
• Last updated: 2025-09-30

Locations

55 sites across 11 countries: United States, Australia, Brazil, France, Germany, Poland, Portugal, South Korea, Spain, Taiwan, United Kingdom

Regulatory

• FDA-regulated drug study