A Study of TX000045 in Patients With Pulmonary Hypertension Secondary to Heart Failure With Preserved Ejection Fraction (the APEX Study)
PHASE2ACTIVE_NOT_RECRUITING
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).
Study details:
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.
Eligibility criteria
Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.
Inclusion criteria
- Is a male or female of non-childbearing potential between the ages of 18 and 83 years.
- Has a diagnosis of PH-HFpEF based on baseline echocardiogram and right heart catheterization (RHC).
- Has NYHA functional class II- III heart failure.
- Has 6MWT distance from 100 to 450m.
- Chronic medication for heart failure or cardiovascular disease is at a stable dose prior to screening.
- Is able to understand and provide documented consent for participation.
Exclusion criteria
- Diagnosis of PH in World Health Organization (WHO) Group 1, WHO Group 3, WHO Group 4, or WHO Group 5.
- Current or recent hospitalization prior to screening.
- Recently received vasoactive drugs, pulmonary arterial hypertension-specific therapies, or a relaxin receptor agonist.
- Initiated a new exercise program for cardiopulmonary rehabilitation or plans to initiate such a program during the study.
- Has a body mass index <18 kg/meter square or >45 kg/ meter square.
- Was previously administered TX000045, relaxin, or a relaxin fusion protein.
- Historical or current evidence of a clinically significant disease or disorder such as significant lung disease, cardiovascular comorbitiies, liver disease, infectious disease, or malignancy.
- Has any of the following clinical laboratory values during screening: Serum alanine aminotransferase or aspartate aminotransferase levels > 3 x the upper limit of normal (ULN) or total bilirubin > 3 x ULN; eGFR <30 mL/min/1.73 m2; HbA1c (glycosylated hemoglobin) >9%; Platelet count <50,000/millimeter cube; Hemoglobin <10.0g/dL;
- History of hypersensitivity or reactions to drugs with a similar chemical structure or class to TX000045.
- Is pregnant or breastfeeding.
- Has a history of cancer within 5 years of screening other than basal cell carcinoma, cervical carcinoma, or squamous cell carcinomas of the skin.
- Has a history of drug or alcohol abuse.
- Was recently dosed in any clinical research study.
Eligibility
Age eligible for study : NA
Healthy volunteers accepted : No
Gender eligible for study: ALL
Things to know
Study dates
Study start:
Primary completion:
Study completion finish:
Study type
TREATMENT
Phase
- PHASE2
Study ID
NCT06616974
Intervention or treatment
DRUG: TX000045- Dose A
DRUG: TX000045- Dose B
DRUG: Placebo
Conditions
- Pulmonary Hypertension
- Heart Failure With Preserved Ejection Fraction
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Research sites nearby
Closest Location:
Malvern
Select from list below to view details:
Malvern
Malvern, Victoria, Australia
Macquarie
Macquarie, New South Wales, Australia
Sydney
Sydney, New South Wales, Australia
Wollongong
Wollongong, New South Wales, Australia
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Who is running the clinical trial?
TT
Tectonic Therapeutic
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
| Participant Group/Arm | Intervention/Treatment |
|---|---|
EXPERIMENTAL: TX000045 Dose A
| Drug: TX000045- Dose A |
EXPERIMENTAL: TX000045 Dose B
| Drug: TX000045- Dose B |
PLACEBO_COMPARATOR: Placebo
| Drug: Placebo |
What is the study measuring?
Primary Outcome
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | Not Specified | Baseline up to Week 30 post first dose |
| Number of participants with abnormal laboratory values and/or adverse events that are related to treatment. | Not Specified | Baseline up to Week 30 post first dose |
| Number of participants with treatment-related adverse events. | Not Specified | Baseline up to Week 30 post first dose |
| Number of participants with changes in the physical examination findings. | Not Specified | Baseline to Week 30 post first dose |
Secondary Outcome
| Measure | Description | Time Frame |
|---|---|---|
| Mean change from baseline in pulmonary capillary wedge pressure (PCWP). | Measured by RHC between those who received TX000045 and those with placebo. | 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. | Baseline to Week 24 post first dose |
| Mean change from baseline in cardiac output (CO) for all participants and in participants with CpcPH. | This is measured by RHC between those who received TX000045 and those with placebo. | 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. | 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. | 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. | 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. | Not Specified | 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 KCCQ scores. 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. | Baseline to Week 24 post first dose |
| Evaluate the serum concentrations of TX000045. | Not Specified | 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). | Not Specified | Day 1, Week 2, Week 4, Week 8, Week 16, Week 24 and Week 30 post first dose |
Are you running this trial?If you're a clinic or sponsor, you can claim this study.
References
Clinical Trials Gov: A Study of TX000045 in Patients With Pulmonary Hypertension Secondary to Heart Failure With Preserved Ejection Fraction (the APEX Study)Other trials to consider
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