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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)
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.
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.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
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
Start Date
October 17, 2023
Primary Completion Date
March 5, 2025
Completion Date
March 11, 2025
Last Updated
September 30, 2025
113
ACTUAL participants
Dose A KER-012
BIOLOGICAL
Dose B KER-012
BIOLOGICAL
Dose C KER-012
BIOLOGICAL
Placebo for 24 Weeks followed by Dose B KER-012 for 72 weeks
BIOLOGICAL
Lead Sponsor
Keros Therapeutics, Inc.
NCT07218029
NCT06649110
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT06481852