Phase
Condition
Stress
Circulation Disorders
Vascular Diseases
Treatment
Dose A KER-012
Dose B KER-012
Dose C KER-012
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
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 ofPAH:
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 symptomsas assessed by the Investigator
Must be on a stable PAH background therapy with either an endothelin-receptorantagonist (ERA) and/or a phosphodiesterase-5 inhibitor (PDE5-I) or solubleguanylate 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 ofany Screening tests or procedures
Exclusion
Exclusion Criteria:
Evidence or history of left ventricular dysfunction and/or clinically significantcardiac disease
Has pulmonary function tests (PFTs) with evidence of significant obstructive orparenchymal lung disease
Evidence of thromboembolic disease assessed by ventilation perfusion (V/Q) lung scanor other local standard of care diagnostic evaluation at the time of PAH diagnosisor after
Has uncontrolled systemic hypertension
Hemoglobin < 9 g/dL at Screening
Prior heart or heart-lung transplants, active on the lung transplant list, or lifeexpectancy of < 12 months per Investigator assessment
Diagnosis of pulmonary veno-occlusive disease or pulmonary capillary hemangiomatosis
Initiation or discontinuation of an exercise program for cardiopulmonaryrehabilitation within 90 days prior to Baseline or planned initiation during thestudy
Prior participation in a KER-012 study or prior treatment with a therapy targetingTGF-β superfamily (e.g. sotatercept)
Prior participation in another interventional clinical study with medicinal productswithin 30 days or 5 half-lives prior to Screening, whichever is longer
Study Design
Study Description
Connect with a study center
TROPOS Study Site 805
Melbourne, Victoria 3004
AustraliaSite Not Available
The Alfred Hospital
Melbourne, Victoria 3004
AustraliaSite Not Available
TROPOS Study Site 807
Auchenflower, 4066
AustraliaSite Not Available
Royal Prince Alfred Hospital
Camperdown, 2050
AustraliaActive - Recruiting
TROPOS Study Site 804
Camperdown, 2050
AustraliaSite Not Available
St. Vincent Hospital Sydney
Darlinghurst, 2010
AustraliaActive - Recruiting
TROPOS Study Site 800
Darlinghurst, 2010
AustraliaSite Not Available
John Hunter Hospital
New Lambton Heights, 2305
AustraliaActive - Recruiting
TROPOS Study Site 803
New Lambton Heights, 2305
AustraliaSite Not Available
Macquarie University
Sydney, 2095
AustraliaActive - Recruiting
TROPOS Study Site 801
Sydney, 2095
AustraliaSite Not Available
TROPOS Study Site 200
Blumenau, 89030
BrazilSite Not Available
TROPOS Study Site 202
Porto Alegre, 90020
BrazilSite Not Available
TROPOS Study Site 201
São Paulo, 05403
BrazilSite Not Available
TROPOS Study Site 320
Le Kremlin-Bicêtre, 94270
FranceSite Not Available
TROPOS Study Site 341
Giesen, 35392
GermanySite Not Available
TROPOS Study Site 340
Hannover, 30625
GermanySite Not Available
TROPOS Study Site 343
Heidelberg, 69120
GermanySite Not Available
TROPOS Study Site 344
Homburg, 66424
GermanySite Not Available
TROPOS Study Site 342
Leipzig, 04103
GermanySite Not Available
TROPOS Study Site 345
Regensburg, 93053
GermanySite Not Available
TROPOS Study Site 881
Incheon, 21565
Korea, Republic ofSite Not Available
TROPOS Study Site 880
Seoul, 06351
Korea, Republic ofSite Not Available
TROPOS Study Site 882
Seoul, 03722
Korea, Republic ofSite Not Available
TROPOS Study Site 883
Seoul, 03080
Korea, Republic ofSite Not Available
TROPOS Study Site 704
Gdańsk, 80-214
PolandSite Not Available
TROPOS Study Site 701
Kraków, 31-202
PolandSite Not Available
TROPOS Study Site 702
Otwock, 05-400
PolandSite Not Available
TROPOS Study Site 703
Poznań, 60-355
PolandSite Not Available
TROPOS Study Site 706
Poznań, 61-848
PolandSite Not Available
TROPOS Study Site 705
Łódź, 91-347
PolandSite Not Available
TROPOS Study Site 403
Almada, 2805-267
PortugalSite Not Available
TROPOS Study Site 402
Coimbra, 3000-075
PortugalSite Not Available
TROPOS Study Site 400
Lisboa, 1769-001
PortugalSite Not Available
TROPOS Study Site 401
Porto, 4099-001
PortugalSite Not Available
TROPOS Study Site 412
Barcelona, 39008
SpainSite Not Available
TROPOS Study Site 413
Barcelona, 8035
SpainSite Not Available
TROPOS Study Site 410
Madrid, 28041
SpainSite Not Available
TROPOS Study Site 411
Santander, 39008
SpainSite Not Available
TROPOS Study Site 891
Kaohsiung, 81362
TaiwanSite Not Available
TROPOS Study Site 890
Taipei, 11217
TaiwanSite Not Available
TROPOS Study Site 441
Glasgow, G81 4DY
United KingdomSite Not Available
TROPOS Study Site 440
London, W12 0HS
United KingdomSite Not Available
TROPOS Study Site 442
London, SW3 6NP
United KingdomSite Not Available
TROPOS Study Site 111
Scottsdale, Arizona 85258
United StatesSite Not Available
TROPOS Study Site 107
Tucson, Arizona 85719
United StatesSite Not Available
Site PI TROPOS Study Site 104
Stanford, California 94305
United StatesSite Not Available
Lundquist Institute for Biomedical Innovation at Harbor UCLA
Torrance, California 90502
United StatesSite Not Available
TROPOS Study Site 105
Torrance, California 90502
United StatesSite Not Available
TROPOS Study Site 108
Jacksonville, Florida 32224
United StatesSite Not Available
TROPOS Study Site 100
Kansas City, Kansas 66160
United StatesSite Not Available
University of Kansas Medical Center
Kansas City, Kansas 66160
United StatesActive - Recruiting
TROPOS Study Site 110
Louisville, Kentucky 40202
United StatesSite Not Available
TROPOS Study Site 103
Boston, Massachusetts 02111
United StatesSite Not Available
TROPOS Study Site 109
Boston, Massachusetts 02115
United StatesSite Not Available
Tufts Medical Center
Boston, Massachusetts 02111
United StatesSite Not Available
TROPOS Study Site 101
Ann Arbor, Michigan 481091
United StatesSite Not Available
TROPOS Study Site 115
Saint Louis, Missouri 63110
United StatesSite Not Available
TROPOS Study Site 114
Albuquerque, New Mexico 87106
United StatesSite Not Available
The University of New Mexico - UNM Hospitals
Albuquerque, New Mexico 87106
United StatesActive - Recruiting
TROPOS Study Site 113
Cincinnati, Ohio 45221
United StatesSite Not Available
TROPOS Study Site 106
Charleston, South Carolina 29425
United StatesSite Not Available
TROPOS Study Site 112
Dallas, Texas 75390
United StatesSite Not Available
TROPOS Study Site 102
Houston, Texas 77030
United StatesSite Not Available
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