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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).
Sponsor: Keros Therapeutics, Inc.
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.
Official title: 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)
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
113
Start Date
2023-10-17
Completion Date
2025-03-11
Last Updated
2026-07-02
Healthy Volunteers
No
Conditions
Interventions
Dose A KER-012
Dose A KER-012 (Q4W);
Dose B KER-012
Dose B KER-012 (Q4W);
Dose C KER-012
Dose C KER-012 (Q4W);
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)
Locations (55)
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