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A Study of TX000045 in Patients With Pulmonary Hypertension Secondary to Heart Failure With Preserved Ejection Fraction (the APEX Study)

PHASE2RECRUITING

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).

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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.

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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 comorbidities, liver disease, infectious disease, or malignancy.

Has any of the following clinical laboratory values during screening: 1. Serum alanine aminotransferase or aspartate aminotransferase levels > 3 x the upper limit of normal (ULN) or total bilirubin > 3 x ULN; 2. eGFR <30 mL/min/1.73 m2; 3. HbA1c (glycosylated hemoglobin) >9%; 4. Platelet count <50,000/millimeter cube; 5. 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.

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Eligibility

Age eligible for study : 18 and older

Healthy volunteers accepted : No

Gender eligible for study: All

Things to know

Study dates

Study start: 2024-10-08

Primary completion: 2026-10-09

Study completion finish: 2026-11-20

Study type

TREATMENT

Phase

PHASE2

Trial ID

NCT06616974

Intervention or treatment

DRUG: TX000045- Dose A

DRUG: TX000045- Dose B

DRUG: Placebo

Conditions

• Pulmonary Hypertension
• Heart Failure With Preserved Ejection Fraction

Condition: Pulmonary Hypertension, Heart Failure With Preserved Ejection Fraction
DRUG: TX000045- Dose A and other drugs
Macquarie, New South Wales, Australia and more
Sponsor: Tectonic Therapeutic

You may be eligible to participate in this trial based on your search. Check eligibility by answering some questions.

Are you running this trial? If you're a clinic or sponsor, you can claim this study. Claim or learn more.

Find a site

Closest Location:

Westmead Hospital

Research sites nearby

Select from list below to view details:

Westmead Hospital
Macquarie, New South Wales, Australia
Wollongong
Wollongong, New South Wales, Australia
Auchenflower
Auchenflower, Queensland, Australia
Chermside
Chermside, Queensland, Australia

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 Participants will receive a single dose of TX000045 Dose A subcutaneously every 2 weeks for 24 weeks from Day 1 to Day 155.	DRUG: TX000045- Dose A The participants will receive a subcutaneous injection of Dose A of TX000045 every 2 weeks for 24 weeks.
EXPERIMENTAL: TX000045 Dose B Participants will receive alternating single doses of TX000045 Dose B and placebo subcutaneously every 2 weeks for 24 weeks from Day 1 to Day 155.	DRUG: TX000045- Dose B 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.
PLACEBO_COMPARATOR: Placebo Participants will receive a single placebo dose SC for 24 weeks from Day 1 to Day 155	DRUG: Placebo The participants will receive a subcutaneous injection of placebo every 2 weeks for 24 weeks.

What is the study measuring?

Primary outcome

Primary Outcome Measure	Primary Outcome Description	Primary Outcome Time Frame
Change from baseline on mean Pulmonary Vascular Resistance (PVR) in participants with pulmonary hypertension secondary to heart failure with preserved ejection fraction (PH-HFpEF)	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 24 post first dose
Number of participants with changes in the physical examination findings	Not Specified	Baseline to Week 30 post first dose

Secondary outcome

Secondary Outcome Measure	Secondary Outcome Description	Secondary Outcome Time Frame
Effect of TX000045 on mean PVR in participants with PVR greater than or equal to 3 wood units.	This is measured by RHC in participants with PVR greater than or equal to 3 wood units.	Baseline to Week 24 post first dose
Mean change from baseline in 6-minute walk test (6MWT) distance.	To evaluate the effect of TX000045 on exercise capacity in participants with PH-HFpEF those who have received TX000045 and placebo.	Baseline to Week 24 post first dose
Mean change from baseline in 6-minute walk test (6MWT) distance in participants with PVR greater than or equal to 3 wood units.	To evaluate the effect of TX000045 on exercise capacity in participants with PVR greater than or equal to 3 wood units those who have received TX000045 and placebo.	Baseline to Week 30 post first dose
Change from baseline in Pulmonary capillary wedge pressure (PCWP) in patients who received TX000045 vs Placebo.	To evaluate the effect on TX000045 vs Placebo on pulmonary capillary wedge pressure (PCWP) in participants with PH-HFpEF.	Baseline to Week 24 post first dose
Change from baseline in mean pulmonary arterial pressure (mPAP) in participants who received TX000045 vs Placebo.	To evaluate the effect of TX000045 vs Placebo on mPAP in participants with PH-HFpEF.	Baseline to Week 24 post first dose
Change from baseline in N-terminal pro-brain natriuretic peptide (NT-proBNP) in participants with PH-HFpEF.	To evaluate the effect of TX000045 vs. Placebo on NT-proBNP levels.	Baseline to Week 30 post first dose
Change from baseline responses on the Kansas City Cardiomyopathy Questionnaire (KCCQ) in participants with PH-HFpEF.	To evaluate the effect of TX000045 vs. Placebo on KCCQ scores	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
Evaluate immunogenicity of TX000045 by antibody titers	Not Specified	Day 1, Week 2, Week 4, Week 8, Week 16, Week 24 and Week 30 post first dose

Frequently Asked Questions

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References

Clinical Trials Gov: A Study of TX000045 in Patients With Pulmonary Hypertension Secondary to Heart Failure With Preserved Ejection Fraction (the APEX Study)