Keros PAH Study

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)

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Pulmonary arterial hypertension (PAH)
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All genders
person-wave 18-100
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Overview
Principal Investigator: Ioana R. Preston, MD

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 details
Inclusion Criteria
  • 1. Has WHO/NYHA FC II or III symptoms
  • 2. Participant must be on a stable PAH background therapy
  • 3. 6MWD ≥ 150 and ≤ 500 meters repeated twice at Screening
Exclusion Criteria
  • 1. Body mass index (BMI) ≥ 35 kg/m2
  • 2. Ongoing, more than mild obstructive sleep apnea that is untreated.
  • 3. History of cerebrovascular accident within 3 months before Screening
Study Requirements

The Treatment Period is expected to be 24 weeks. Participants who complete the Treatment Period will be eligible to continue into a 72-week Extension Period, for a total of 96 weeks on treatment. Visits will include but not limited to, 6 minute walk test, right heart catheterization, pulmonary function test, ECG, blood draw, and wearing an actigraphy.