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

Last updated: September 25, 2024
Sponsor: Tectonic Therapeutic
Overall Status: Active - Recruiting

Phase

2

Condition

Scleroderma

Circulation Disorders

Stress

Treatment

Placebo

TX000045- Dose A

TX000045- Dose B

Clinical Study ID

NCT06616974
TX000045-003
  • Ages 18-80
  • All Genders

Study Summary

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).

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Is a male or female of non-childbearing potential between the ages of 18 and 80years.

  2. Has a diagnosis of PH-HFpEF based on baseline echocardiogram and right heartcatheterization (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 doseprior to screening.

  6. Is able to understand and provide documented consent for participation.

Exclusion

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-specifictherapies, or relaxin receptor agonist.

  4. Initiated a new exercise program for cardiopulmonary rehabilitation or plans toinitiate 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 suchas significant lung disease, cardiovascular comorbitiies, liver disease, infectiousdisease, or malignancy.

  8. Has any of the following clinical laboratory values during screening:

  9. Serum alanine aminotransferase or aspartate aminotransferase levels > 3 x theupper limit of normal (ULN) or total bilirubin > 3 x ULN;

  10. eGFR <30 mL/min/1.73 metersquare;

  11. HbA1c (glycosylated hemoglobin) >9%;

  12. Platelet count <50,000/millimeter cube;

  13. Hemoglobin <10.0g/dL;

  14. History of hypersensitivity or reactions to drugs with a similar chemical structureor class to TX000045.

  15. Is pregnant or breastfeeding.

  16. Has a history of cancer other than basal cell carcinoma, cervical carcinoma, orsquamous cell carcinomas of the skin.

  17. Has a history of drug or alcohol abuse.

  18. Was recently dosed in any clinical research study.

Study Design

Total Participants: 180
Treatment Group(s): 3
Primary Treatment: Placebo
Phase: 2
Study Start date:
September 30, 2024
Estimated Completion Date:
November 20, 2026

Study 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

Connect with a study center

  • Yerevan

    Yerevan, 0006
    Armenia

    Site Not Available

  • Westmead Hospital

    Macquarie, New South Wales 2109
    Australia

    Site Not Available

  • Wollongong

    Wollongong, New South Wales 2500
    Australia

    Site Not Available

  • Auchenflower

    Auchenflower, Queensland 4066
    Australia

    Site Not Available

  • Chermside

    Chermside, Queensland 4032
    Australia

    Site Not Available

  • Hobart

    Hobart, Tasmania 7000
    Australia

    Site Not Available

  • Pleven

    Pleven, 5800
    Bulgaria

    Site Not Available

  • Plovdiv

    Plovdiv, 4004
    Bulgaria

    Site Not Available

  • Sofia

    Sofia, 1700
    Bulgaria

    Site Not Available

  • Tbilisi

    Tbilisi, Tb 0186
    Georgia

    Site Not Available

  • Hamburg

    Hamburg, 20246
    Germany

    Site Not Available

  • Mainz

    Mainz, 55131
    Germany

    Site Not Available

  • Remscheid

    Remscheid, 42859
    Germany

    Site Not Available

  • Chisinau

    Chisinau,
    Moldova, Republic of

    Active - Recruiting

  • Christchurch

    Christchurch, 8011
    New Zealand

    Site Not Available

  • Białystok

    Białystok, 15-276
    Poland

    Site Not Available

  • Krakow

    Kraków, 31-202
    Poland

    Site Not Available

  • Lublin

    Lublin, 20-090
    Poland

    Site Not Available

  • Łodź

    Łódź, 91-347
    Poland

    Site Not Available

  • Barcelona

    Barcelona, 8035
    Spain

    Site Not Available

  • Madrid

    Madrid, 28034
    Spain

    Site Not Available

  • Santiago de Compostela ( Coruña )

    Santiago De Compostela, 15706
    Spain

    Site Not Available

  • Valencia

    Valencia, 46010
    Spain

    Site Not Available

  • Gaziantep

    Gaziantep, 27310
    Turkey

    Site Not Available

  • Istanbul

    Istanbul, 34899
    Turkey

    Site Not Available

  • Birmingham

    Birmingham, Alabama 35205
    United States

    Site Not Available

  • Aurora

    Aurora, Colorado 80045
    United States

    Site Not Available

  • Covington

    Covington, Georgia 70433
    United States

    Site Not Available

  • Boston

    Boston, Massachusetts 02180
    United States

    Site Not Available

  • Jackson

    Jackson, Mississippi 39216
    United States

    Site Not Available

  • St Louis

    Saint Louis, Missouri 63110
    United States

    Site Not Available

  • New York

    New York, New York 10029
    United States

    Site Not Available

  • Durham

    Durham, North Carolina 27710
    United States

    Site Not Available

  • Toledo

    Toledo, Ohio 43606
    United States

    Site Not Available

  • Pittsburgh

    Pittsburgh, Pennsylvania 15213
    United States

    Site Not Available

  • York

    York, Pennsylvania 17403
    United States

    Site Not Available

  • Nashville

    Nashville, Tennessee 37205
    United States

    Site Not Available

  • Beaumont

    Beaumont, Texas 77702
    United States

    Site Not Available

  • Port Arthur

    Port Arthur, Texas 77642
    United States

    Site Not Available

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