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NCT06616974

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

StatusActive, Not Recruiting
PhasePhase 2
Primary completion (estimated)
Track this trial

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Record History

All 6 versions: 6 with changes below. See every version on ClinicalTrials.gov ↗

  1. Trial status changed: Recruiting → Active, Not Recruitingv6 Show 5 more changesShow less
    • Primary completion pushed from Oct 9, 2026 to Nov 24, 2026
    • Trial sites reduced: 86 → 72 locations
    • Study completion pushed from Nov 20, 2026 to Jan 5, 2027
    • Enrollment target: 180 to 191
    • Study description revised
  2. Site details revised at 4 of 86 sitesv5
  3. Study sites: 81 to 86v4
  4. Study sites: 63 to 81
    • Start date: Oct 8, 2024 to Sep 4, 2024
    • Secondary endpoints revised (10)
    v3
  5. Eligibility criteria expanded, about 6 wordsv2 Show 4 more changesShow less
    • Primary endpoints revised (5)
    • Study sites: 43 to 63
    • Start date changed from estimate of Sep 30, 2024 to Oct 8, 2024
    • Secondary endpoints: 9 to 10
  6. Study First Submitted
  • Notable: the plan changed
  • Minor: routine updates

Endpoints

Primary

Mean change from baseline in Pulmonary Vascular Resistance (PVR) in participants with a combined pre- and post-capillary pulmonary hypertension (CpcPH).
Timeframe: 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.
Timeframe: Baseline up to Week 30 post first dose
Number of participants with abnormal laboratory values and/or adverse events that are related to treatment.
Timeframe: Baseline up to Week 30 post first dose
Number of participants with treatment-related adverse events.
Timeframe: Baseline up to Week 30 post first dose
Number of participants with changes in the physical examination findings.
Timeframe: Baseline to Week 30 post first dose

Secondary (10)

Mean change from baseline in pulmonary capillary wedge pressure (PCWP).
Mean change from baseline in PVR for all participants.
Mean change from baseline in cardiac output (CO) for all participants and in participants with CpcPH.
Mean change from baseline in exercise capacity in all participants and in participants with CpcPH.
Mean change from baseline in total pulmonary resistance (TPR) for all participants and in participants with CpcPH.
Show 5 moreShow less
Mean change from baseline in mean pulmonary arterial pressure (mPAP) for all participants and in participants with CpcPH.
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.
Mean change from baseline responses on the Kansas City Cardiomyopathy Questionnaire (KCCQ) for all participants and in participants with CpcPH.
Evaluate the incidence of immunogenicity of TX000045 by the number of participants with detectable anti-drug antibody titers.
Number of participants with change in antibody titers following treatment with TX000045 (Immunogenicity).

Arms and interventions

TX000045 Dose AExperimental

Participants will receive a single dose of TX000045 Dose A subcutaneously every 2 weeks for 24 weeks from Day 1 to Day 155.

TX000045 Dose BExperimental

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.

PlaceboPlacebo comparator

Participants will receive a single placebo dose SC for 24 weeks from Day 1 to Day 155

Drugs: TX000045- Dose A, TX000045- Dose B, Placebo

Sites

72 sites in 17 countries

United States 25, Australia 10, Poland 6, Spain 5, Georgia 4, Serbia 4, Armenia 3, Portugal 3, Romania 3, Bulgaria 2, Austria 1, Belgium 1, Germany 1, Latvia 1, Moldova 1, New Zealand 1, Ukraine 1