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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
113
Dose A KER-012 (Q4W);
Dose B KER-012 (Q4W);
Dose C KER-012 (Q4W);
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
Time frame: Baseline and Week 24
Change From Baseline in the 6MWD
Evaluate the effect of KER-012 on exercise capacity compared to Placebo in participants on background PAH therapy
Time frame: Through week 24 (primary treatment period)
Evaluate Improvement in Functional Assessment of KER-012 Compared to Placebo in Participants on Background PAH Therapy
Proportion of participants who achieved improvement from Baseline in NYHA FC/WHO at week 24. Improvement in WHO/NYHA FC (World Heath Association/New York Heart Association functional class) was defined as a decreased in functional class from baseline or maintenance of WHO/NYHA = 2 from baseline.
Time frame: Up to week 24 (primary treatment period)
Evaluate the Changes From Baseline in the Concentration of the PAH Biomarker, NT-proBNP in Blood Samples
Change from Baseline in NT-proBNP at week 24
Time frame: Up to week 24 (primary treatment period)
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Treatment Period (24 weeks): Placebo SC (Q4W) Extension Period (72 weeks after Placebo treatment): KER-012 (Dose B) SC (Q4W)
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
...and 45 more locations