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

Phases

Phase 2

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2022-502378-17-00

Acronym

KER-012-A201

Enrollment

Registered

2024-02-08

Start date

2024-03-20

Completion date

2025-01-14

Last updated

2025-06-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pulmonary Arterial Hypertension

Brief summary

Change from Baseline in pulmonary vascular resistance (PVR) at Week 24.

Detailed description

Change from Baseline in the 6-minute walk distance (6MWD) at Week 24., Incidence of treatment-emergent adverse events (TEAEs), treatment-related TEAEs and discontinuations due to TEAEs; change from baseline in clinical laboratory values, vital signs, and electrocardiogram (ECG); incidence of anti-drug antibodies (ADA).

Interventions

DRUGPlacebo for KER-012

DRUGcibotercept

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Change from Baseline in pulmonary vascular resistance (PVR) at Week 24.	—

Secondary

Measure	Time frame
Change from Baseline in the 6-minute walk distance (6MWD) at Week 24., Incidence of treatment-emergent adverse events (TEAEs), treatment-related TEAEs and discontinuations due to TEAEs; change from baseline in clinical laboratory values, vital signs, and electrocardiogram (ECG); incidence of anti-drug antibodies (ADA).	—

Countries

France, Germany, Poland, Portugal, Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026