Search / Trial NCT06616974

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

Launched by TECTONIC THERAPEUTIC · Sep 25, 2024

Trial Information

Current as of October 08, 2024

Recruiting

Keywords

Description

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

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • 1. Is a male or female of non-childbearing potential between the ages of 18 and 80 years.
  • 2. Has a diagnosis of PH-HFpEF based on baseline echocardiogram and right heart catheterization (RHC).
  • 3. Has NYHA functional class II- III heart failure.
  • 4. Has 6MWT distance from 100 to 450m.
  • 5. Chronic medication for heart failure or cardiovascular disease is at a stable dose prior to screening.
  • 6. Is able to understand and provide documented consent for participation.
  • Exclusion Criteria:
  • 1. Diagnosis of PH in World Health Organization (WHO) Group 1, WHO Group 3, WHO Group 4, or WHO Group 5.
  • 2. Current or recent hospitalization prior to screening.
  • 3. Recently received vasoactive drugs, pulmonary arterial hypertension-specific therapies, or relaxin receptor agonist.
  • 4. Initiated a new exercise program for cardiopulmonary rehabilitation or plans to initiate such a program during the study.
  • 5. Has a body mass index \<18 kg/meter square or \>45 kg/ meter square.
  • 6. Was previously administered TX000045, relaxin, or a relaxin fusion protein.
  • 7. Historical or current evidence of a clinically significant disease or disorder such as significant lung disease, cardiovascular comorbitiies, liver disease, infectious disease, or malignancy.
  • 8. 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 metersquare;
  • 3. HbA1c (glycosylated hemoglobin) \>9%;
  • 4. Platelet count \<50,000/millimeter cube;
  • 5. Hemoglobin \<10.0g/dL;
  • 9. History of hypersensitivity or reactions to drugs with a similar chemical structure or class to TX000045.
  • 10. Is pregnant or breastfeeding.
  • 11. Has a history of cancer other than basal cell carcinoma, cervical carcinoma, or squamous cell carcinomas of the skin.
  • 12. Has a history of drug or alcohol abuse.
  • 13. Was recently dosed in any clinical research study.

About Tectonic Therapeutic

Tectonic Therapeutic is a pioneering biopharmaceutical company focused on developing innovative therapies for patients with unmet medical needs. With a commitment to advancing scientific research and clinical development, Tectonic Therapeutic leverages cutting-edge technologies and a robust pipeline to address challenging diseases, particularly in the fields of oncology and rare genetic disorders. The company is dedicated to fostering collaboration with leading researchers and institutions to bring transformative treatments from the laboratory to the clinic, ultimately improving patient outcomes and enhancing quality of life.

Locations

Durham, North Carolina, United States

Mainz, , Germany

Madrid, , Spain

Valencia, , Spain

Birmingham, Alabama, United States

Beaumont, Texas, United States

Aurora, Colorado, United States

New York, New York, United States

Nashville, Tennessee, United States

Pittsburgh, Pennsylvania, United States

Pleven, , Bulgaria

Barcelona, , Spain

Covington, Georgia, United States

Boston, Massachusetts, United States

Jackson, Mississippi, United States

Saint Louis, Missouri, United States

Toledo, Ohio, United States

York, Pennsylvania, United States

Port Arthur, Texas, United States

Yerevan, , Armenia

Macquarie, New South Wales, Australia

Wollongong, New South Wales, Australia

Auchenflower, Queensland, Australia

Chermside, Queensland, Australia

Hobart, Tasmania, Australia

Plovdiv, , Bulgaria

Sofia, , Bulgaria

Tbilisi, Tb, Georgia

Hamburg, , Germany

Remscheid, , Germany

Chisinau, , Moldova, Republic Of

Christchurch, , New Zealand

Białystok, , Poland

Kraków, , Poland

Lublin, , Poland

łódź, , Poland

Santiago De Compostela, , Spain

Gaziantep, , Turkey

Istanbul, , Turkey

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Discussion 0