TX000045-003 is a double-blind, randomized, parallel group, placebo-controlled, proof- of-concept (POC) study, evaluating 2 dose regimens of TX000045 over the course of a 24-week treatment period (the APEX study).
This study will enroll approximately 180 participants and eligible patients will be randomized to one of 3 treatment arms: * Arm 1: Treatment Group 1: Placebo delivered subcutaneously (SC) every 2 weeks (Q2W) for 24 weeks * Arm 2: Treatment Group 2: TX000045 SC at Dose A Q2W for 24 weeks * Arm 3: Treatment Group 3: TX000045 SC at Dose B Q2W alternating with Placebo Q2W for 24 weeks
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
180
The participants will receive a subcutaneous injection of Dose A of TX000045 every 2 weeks for 24 weeks.
The participants will receive subcutaneous injection of Dose B of TX000045 every 4 weeks for 24 weeks where they will alternate between TX000045 and placebo every 2 weeks.
The participants will receive a subcutaneous injection of placebo every 2 weeks for 24 weeks.
Mean change from baseline in Pulmonary Vascular Resistance (PVR) in participants with a combined pre- and post-capillary pulmonary hypertension (CpcPH).
Measured by right heart catheterization (RHC) between those who received TX000045 and those with placebo.
Time frame: Baseline up to Week 24 post first dose
Assess safety of TX000045 by the incidence of adverse events, adverse events of special interest and SAEs.
Time frame: Baseline up to Week 30 post first dose
Number of participants with abnormal laboratory values and/or adverse events that are related to treatment.
Time frame: Baseline up to Week 30 post first dose
Number of participants with treatment-related adverse events.
Time frame: Baseline up to Week 30 post first dose
Number of participants with changes in the physical examination findings.
Time frame: Baseline to Week 30 post first dose
Mean change from baseline in pulmonary capillary wedge pressure (PCWP).
Measured by RHC between those who received TX000045 and those with placebo.
Time frame: Baseline to Week 24 post first dose
Mean change from baseline in PVR for all participants.
Measured by RHC between those who received TX000045 and those with placebo.
Time frame: Baseline to Week 24 post first dose
Mean change from baseline in cardiac output (CO) for all participants and in participants with CpcPH.
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This is measured by RHC between those who received TX000045 and those with placebo.
Time frame: Baseline to Week 24 post first dose
Mean change from baseline in exercise capacity in all participants and in participants with CpcPH.
This is measured by mean change from baseline in 6-minute walk test (6MWT) distance between those who received TX000045 and those with placebo.
Time frame: Baseline to Week 30 post first dose
Mean change from baseline in total pulmonary resistance (TPR) for all participants and in participants with CpcPH.
This is measured by RHC between those who received TX000045 and those with placebo.
Time frame: Baseline to Week 24 post first dose
Mean change from baseline in mean pulmonary arterial pressure (mPAP) for all participants and in participants with CpcPH.
This is measured by RHC between those who received TX000045 and those with placebo.
Time frame: Baseline to Week 24 post first dose
Mean change from baseline in N-terminal pro-brain natriuretic peptide (NT-proBNP) for all participants and in participants with CpcPH between those who received TX000045 and those with placebo.
Time frame: Baseline to Week 30 post first dose
Mean change from baseline responses on the Kansas City Cardiomyopathy Questionnaire (KCCQ) for all participants and in participants with CpcPH.
To evaluate the effect of TX000045 vs. Placebo on Kansas City Cardiomyopathy Questionnaire (KCCQ) scores. Kansas City Cardiomyopathy Questionnaire (KCCQ-12) is a validated tool to assess quality of life in patients with heart failure. It contains 4 subdomains: physical limitation, symptom frequency, QOL, and social limitations. Each subdomain provides an individual score from 0 to 100, with 0 denoting the worst and 100 the best possible health status.
Time frame: Baseline to Week 24 post first dose
Evaluate the incidence of immunogenicity of TX000045 by the number of participants with detectable anti-drug antibody titers.
Time frame: Day 1, Week 2, Week 4, Week 8, Week 16, Week 24 and Week 30 post first dose
Number of participants with change in antibody titers following treatment with TX000045 (Immunogenicity).
Time frame: Day 1, Week 2, Week 4, Week 8, Week 16, Week 24 and Week 30 post first dose