KER-012 (TROPOS study)
Research type
Research Study
Full 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)
IRAS ID
1007494
Contact name
Jay Russak
Contact email
Sponsor organisation
Keros Therapeutics, Inc.
Eudract number
2022-502378-17
Clinicaltrials.gov Identifier
Research summary
Pulmonary arterial hypertension (PAH) results from the blood vessels in the lungs becoming thickened, narrowed, or blocked which make it harder for the blood to flow. This can cause the blood pressure in the lungs to increase making the heart to work harder to pump the blood to the lungs which eventually can lead to a heart failure.
The study drug (called KER-012) binds to proteins involved in unusual thickening of the blood vessels in the lungs. It is hoped that the study drug may restore the normal function of these proteins and thus delay or reverse disease progression.
About 90 participants in approximately 60 study sites worldwide will take part in this study.
Patients will be randomly assigned to 1 of 4 groups. In each group, a different dose of the study drug or placebo will be looked at.
Participant will receive KER-012 or Placebo as an injection under the skin every 4 weeks and will continue to take their other current PAH treatments.
The study treatment will take 24 weeks and the study participants may be able to take part in the extension period of 72 weeks which allows them to continue to receive the study drug or gives the opportunity to take the study drug if they received placebo in the study treatment period.
Study assessments include physical examinations, vital signs, blood/urine samples, right heart catheterisation, lung scan, lung functions tests, ECGs, breathing tests and health questionnaires.REC name
London - Hampstead Research Ethics Committee
REC reference
23/LO/0879
Date of REC Opinion
10 Nov 2023
REC opinion
Further Information Favourable Opinion