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).

NCT ID: NCT05975905

Last Updated: 2025-09-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 113 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-10-17
• Study Completion Date: 2025-03-11

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Arm 1

KER-012 (Dose A) subcutaneously (SC) (every 4 weeks \[Q4W\]) Treatment Period: Dose A for 24 weeks; Extension Period: Dose A for another 72 weeks

Group Type: EXPERIMENTAL

Dose A KER-012

Intervention Type: BIOLOGICAL

Dose A KER-012 (Q4W);

Arm 2

KER-012 (Dose B) SC (Q4W) Treatment Period: Dose B for 24 weeks; Extension Period: Dose B for another 72 weeks

Group Type: EXPERIMENTAL

Dose B KER-012

Intervention Type: BIOLOGICAL

Dose B KER-012 (Q4W);

Arm 3

KER-012 (Dose C) SC (Q4W) Treatment Period: Dose C for 24 weeks; Extension Period: Dose C for another 72 weeks

Group Type: EXPERIMENTAL

Dose C KER-012

Intervention Type: BIOLOGICAL

Dose C KER-012 (Q4W);

Arm 4

Treatment Period: Placebo for 24 weeks; Extension Period: Dose B for another 72 weeks

Group Type: PLACEBO_COMPARATOR

Dose B KER-012

Intervention Type: BIOLOGICAL

Dose B KER-012 (Q4W);

Placebo for 24 Weeks followed by Dose B KER-012 for 72 weeks

Intervention Type: BIOLOGICAL

Treatment Period (24 weeks): Placebo SC (Q4W) Extension Period (72 weeks after Placebo treatment): KER-012 (Dose B) SC (Q4W)

Interventions

Dose A KER-012

Dose A KER-012 (Q4W);

Intervention Type: BIOLOGICAL

Dose B KER-012

Dose B KER-012 (Q4W);

Intervention Type: BIOLOGICAL

Dose C KER-012

Dose C KER-012 (Q4W);

Intervention Type: 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)

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

• Adult participants ≥ 18 years of age
• Symptomatic World Health Organization (WHO) Group 1 Pulmonary Hypertension (PH)(PAH) classified by one of the following subgroups:

• Idiopathic pulmonary arterial hypertension (IPAH);
• Heritable pulmonary arterial hypertension (HPAH);
• Associated with drugs and toxins;
• PAH associated with:

• Connective tissue disease
• Congenital systemic-pulmonary intracardiac shunt
• Has the following hemodynamic parameters that are consistent with the diagnosis of PAH:

• Mean pulmonary arterial pressure (mPAP) > 20 mmHg at rest, AND
• Pulmonary artery wedge pressure (PAWP) ≤ 15 mmHg, AND
• PVR ≥ 5 Wood Units (400 dyn·sec·cm-5)
• Has WHO/New York Heart Association (NYHA) Functional Class (FC) II or III symptoms as assessed by the Investigator
• Must be on a stable PAH background therapy with either an endothelin-receptor antagonist (ERA) and/or a phosphodiesterase-5 inhibitor (PDE5-I) or soluble guanylate cyclase (sGC) stimulator and/or prostacyclin analogue or receptor agonist (oral/inhaled/SC/intravenous)
• 6MWD ≥ 150 and ≤ 500 meters at screening
• Provide written (signed and dated) informed consent form before the initiation of any Screening tests or procedures

Exclusion Criteria

• Evidence or history of left ventricular dysfunction and/or clinically significant cardiac disease
• Has pulmonary function tests (PFTs) with evidence of significant obstructive or parenchymal lung disease
• Evidence of thromboembolic disease assessed by ventilation perfusion (V/Q) lung scan or other local standard of care diagnostic evaluation at the time of PAH diagnosis or after
• Has uncontrolled systemic hypertension
• Hemoglobin < 9 g/dL at Screening
• Prior heart or heart-lung transplants, active on the lung transplant list, or life expectancy of < 12 months per Investigator assessment
• Diagnosis of pulmonary veno-occlusive disease or pulmonary capillary hemangiomatosis
• Initiation or discontinuation of an exercise program for cardiopulmonary rehabilitation within 90 days prior to Baseline or planned initiation during the study
• Prior participation in a KER-012 study or prior treatment with a therapy targeting TGF-β superfamily (e.g. sotatercept)
• Prior participation in another interventional clinical study with medicinal products within 30 days or 5 half-lives prior to Screening, whichever is longer

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Keros Therapeutics, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

TROPOS Study Site 111

Scottsdale, Arizona, United States

TROPOS Study Site 107

Tucson, Arizona, United States

Site PI TROPOS Study Site 104

Stanford, California, United States

TROPOS Study Site 105

Torrance, California, United States

TROPOS Study Site 108

Jacksonville, Florida, United States

TROPOS Study Site 100

Kansas City, Kansas, United States

TROPOS Study Site 110

Louisville, Kentucky, United States

TROPOS Study Site 103

Boston, Massachusetts, United States

TROPOS Study Site 109

Boston, Massachusetts, United States

TROPOS Study Site 101

Ann Arbor, Michigan, United States

TROPOS Study Site 115

St Louis, Missouri, United States

TROPOS Study Site 114

Albuquerque, New Mexico, United States

TROPOS Study Site 113

Cincinnati, Ohio, United States

TROPOS Study Site 106

Charleston, South Carolina, United States

TROPOS Study Site 112

Dallas, Texas, United States

TROPOS Study Site 102

Houston, Texas, United States

TROPOS Study Site 805

Melbourne, Victoria, Australia

TROPOS Study Site 807

Auchenflower, , Australia

TROPOS Study Site 804

Camperdown, , Australia

TROPOS Study Site 800

Darlinghurst, , Australia

TROPOS Study Site 803

New Lambton Heights, , Australia

TROPOS Study Site 801

Sydney, , Australia

TROPOS Study Site 200

Blumenau, , Brazil

TROPOS Study Site 202

Porto Alegre, , Brazil

TROPOS Study Site 201

São Paulo, , Brazil

TROPOS Study Site 320

Le Kremlin-Bicêtre, , France

TROPOS Study Site 341

Giesen, , Germany

TROPOS Study Site 340

Hanover, , Germany

TROPOS Study Site 343

Heidelberg, , Germany

TROPOS Study Site 344

Homburg, , Germany

TROPOS Study Site 342

Leipzig, , Germany

TROPOS Study Site 345

Regensburg, , Germany

TROPOS Study Site 704

Gdansk, , Poland

TROPOS Study Site 701

Krakow, , Poland

TROPOS Study Site 705

Lodz, , Poland

TROPOS Study Site 702

Otwock, , Poland

TROPOS Study Site 703

Poznan, , Poland

TROPOS Study Site 706

Poznan, , Poland

TROPOS Study Site 403

Almada, , Portugal

TROPOS Study Site 402

Coimbra, , Portugal

TROPOS Study Site 400

Lisbon, , Portugal

TROPOS Study Site 401

Porto, , Portugal

TROPOS Study Site 881

Incheon, , South Korea

TROPOS Study Site 883

Seoul, , South Korea

TROPOS Study Site 882

Seoul, , South Korea

TROPOS Study Site 880

Seoul, , South Korea

TROPOS Study Site 412

Barcelona, , Spain

TROPOS Study Site 413

Barcelona, , Spain

TROPOS Study Site 410

Madrid, , Spain

TROPOS Study Site 411

Santander, , Spain

TROPOS Study Site 891

Kaohsiung City, , Taiwan

TROPOS Study Site 890

Taipei, , Taiwan

TROPOS Study Site 441

Glasgow, , United Kingdom

TROPOS Study Site 442

London, , United Kingdom

TROPOS Study Site 440

London, , United Kingdom

Countries

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

Other Identifiers

KER-012-A201

Identifier Type: -

Identifier Source: org_study_id