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 | Completed Phase 2 DMC FDA Drug

• 1 other identifier: KER-012-A201
• Study Type: interventional
• Target: 113
• Locations: 11 countries
• Sites: 55

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.

Conditions

Pulmonary Arterial Hypertension

Keywords

Pulmonary arterial hypertension [PAH]

Outcome Measures

Primary Outcomes (1)

• Change from Baseline in PVR (Pulmonary Vascular Resistance)

  Evaluate the effect of KER-012 on pulmonary hemodynamics compared to Placebo in participants on background pulmonary arterial hypertension (PAH) therapy

  Baseline and Week 24

Secondary Outcomes (16)

• Change from Baseline in the 6MWD

  Through week 24 (primary treatment period) and Through week 96 (extension period)

• Incidence of treatment-emergent adverse events (TEAEs)

  Through week 24 (primary treatment period) and Through week 96 (extension period)

• Number of treatment-related TEAEs

  Through week 24 (primary treatment period) and Through week 96 (extension period)

• Number of discontinuations due to TEAEs

  Through week 24 (primary treatment period) and Through week 96 (extension period)

• Change from baseline in Systolic and Diastolic Blood Pressure

  Through week 24 (primary treatment period) and Through week 96 (extension period)

Study Arms (4)

Arm 1

EXPERIMENTAL

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

Biological: Dose A KER-012

Arm 2

EXPERIMENTAL

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

Biological: Dose B KER-012

Arm 3

EXPERIMENTAL

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

Biological: Dose C KER-012

Arm 4

PLACEBO COMPARATOR

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

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

Interventions

Dose A KER-012 BIOLOGICAL

Dose A KER-012 (Q4W);

Arm 1

Dose B KER-012 BIOLOGICAL

Dose B KER-012 (Q4W);

Arm 2; Arm 4

Dose C KER-012 BIOLOGICAL

Dose C KER-012 (Q4W);

Arm 3

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

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

Arm 4

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)
• MWD ≥ 150 and ≤ 500 meters at screening

You may not qualify if:

• 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

Sponsors & Collaborators

• Keros Therapeutics, Inc.: lead

Study Sites (55)

TROPOS Study Site 111

Scottsdale, Arizona, 85258, United States

Location

TROPOS Study Site 107

Tucson, Arizona, 85719, United States

Location

Site PI TROPOS Study Site 104

Stanford, California, 94305, United States

Location

TROPOS Study Site 105

Torrance, California, 90502, United States

Location

TROPOS Study Site 108

Jacksonville, Florida, 32224, United States

Location

TROPOS Study Site 100

Kansas City, Kansas, 66160, United States

Location

TROPOS Study Site 110

Louisville, Kentucky, 40202, United States

Location

TROPOS Study Site 103

Boston, Massachusetts, 02111, United States

Location

TROPOS Study Site 109

Boston, Massachusetts, 02115, United States

Location

TROPOS Study Site 101

Ann Arbor, Michigan, 481091, United States

Location

TROPOS Study Site 115

St Louis, Missouri, 63110, United States

Location

TROPOS Study Site 114

Albuquerque, New Mexico, 87106, United States

Location

TROPOS Study Site 113

Cincinnati, Ohio, 45221, United States

Location

TROPOS Study Site 106

Charleston, South Carolina, 29425, United States

Location

TROPOS Study Site 112

Dallas, Texas, 75390, United States

Location

TROPOS Study Site 102

Houston, Texas, 77030, United States

Location

TROPOS Study Site 805

Melbourne, Victoria, 3004, Australia

Location

TROPOS Study Site 807

Auchenflower, 4066, Australia

Location

TROPOS Study Site 804

Camperdown, 2050, Australia

Location

TROPOS Study Site 800

Darlinghurst, 2010, Australia

Location

TROPOS Study Site 803

New Lambton Heights, 2305, Australia

Location

TROPOS Study Site 801

Sydney, 2095, Australia

Location

TROPOS Study Site 200

Blumenau, 89030, Brazil

Location

TROPOS Study Site 202

Porto Alegre, 90020, Brazil

Location

TROPOS Study Site 201

São Paulo, 05403, Brazil

Location

TROPOS Study Site 320

Le Kremlin-Bicêtre, 94270, France

Location

TROPOS Study Site 341

Giesen, 35392, Germany

Location

TROPOS Study Site 340

Hanover, 30625, Germany

Location

TROPOS Study Site 343

Heidelberg, 69120, Germany

Location

TROPOS Study Site 344

Homburg, 66424, Germany

Location

TROPOS Study Site 342

Leipzig, 04103, Germany

Location

TROPOS Study Site 345

Regensburg, 93053, Germany

Location

TROPOS Study Site 704

Gdansk, 80-214, Poland

Location

TROPOS Study Site 701

Krakow, 31-202, Poland

Location

TROPOS Study Site 705

Lodz, 91-347, Poland

Location

TROPOS Study Site 702

Otwock, 05-400, Poland

Location

TROPOS Study Site 703

Poznan, 60-355, Poland

Location

TROPOS Study Site 706

Poznan, 61-848, Poland

Location

TROPOS Study Site 403

Almada, 2805-267, Portugal

Location

TROPOS Study Site 402

Coimbra, 3000-075, Portugal

Location

TROPOS Study Site 400

Lisbon, 1769-001, Portugal

Location

TROPOS Study Site 401

Porto, 4099-001, Portugal

Location

TROPOS Study Site 881

Incheon, 21565, South Korea

Location

TROPOS Study Site 883

Seoul, 03080, South Korea

Location

TROPOS Study Site 882

Seoul, 03722, South Korea

Location

TROPOS Study Site 880

Seoul, 06351, South Korea

Location

TROPOS Study Site 412

Barcelona, 39008, Spain

Location

TROPOS Study Site 413

Barcelona, 8035, Spain

Location

TROPOS Study Site 410

Madrid, 28041, Spain

Location

TROPOS Study Site 411

Santander, 39008, Spain

Location

TROPOS Study Site 891

Kaohsiung City, 81362, Taiwan

Location

TROPOS Study Site 890

Taipei, 11217, Taiwan

Location

TROPOS Study Site 441

Glasgow, G81 4DY, United Kingdom

Location

TROPOS Study Site 442

London, SW3 6NP, United Kingdom

Location

TROPOS Study Site 440

London, W12 0HS, United Kingdom

Location

MeSH Terms

Conditions

Pulmonary Arterial Hypertension

Condition Hierarchy (Ancestors)

Hypertension, Pulmonary; Lung Diseases; Respiratory Tract Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: This is a double-blind study in which treatment assignment will be blinded for the Investigators and any personnel (other than the unblinded pharmacist or designee) involved with the study conduct or evaluation at the investigational sites, the CRO, and the Sponsor.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Participants will be randomly assigned in a 2:2:2:3 ratio to 1 of 4 treatment arms.

Study Record Dates

• First Submitted: July 13, 2023
• First Posted: August 4, 2023
• Study Start: October 17, 2023
• Primary Completion: March 5, 2025
• Study Completion: March 11, 2025
• Last Updated: September 30, 2025

Record last verified: 2025-09

Locations

FR (1); DE (6); TW (2); KR (4); BR (3); ES (4); GB (3); PL (6); AU (6); US (16); PT (4)