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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 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 113

Last updated 2025-09-30

No results posted yet for this study

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.

Conditions

Interventions

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)

Sponsors & Collaborators

  • Keros Therapeutics, Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-10-17
Primary Completion
2025-03-05
Completion
2025-03-11
FDA Drug
Yes

Countries

  • United States
  • Australia
  • Brazil
  • France
  • Germany
  • Poland
  • Portugal
  • South Korea
  • Spain
  • Taiwan
  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05975905 on ClinicalTrials.gov