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NCT Number: NCT07473700

Study of TX000045 in Participants With Pulmonary Hypertension Due to Interstitial Lung Disease

The primary purpose of this study is to assess the effect of TX000045 on pulmonary vascular resistance (PVR) in participants with pulmonary hypertension secondary to interstitial lung disease (PH-ILD) and to assess the safety and tolerability of TX000045 in participants with PH-ILD.

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Key information

Conditions

Hypertension, Pulmonary Cardiovascular Diseases Hypertension Lung Diseases Lung Diseases, Interstitial Respiratory Tract Diseases Vascular Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Krakow, Poland

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Confirmed diagnosis of ILD based on imaging: chest computed tomography (CT) performed within the past 12 months with fibrotic lung disease (greater than or equal to (>=) 10 percent (%) lung parenchyma with fibrosis) consistent with idiopathic interstitial pneumonia, ILD in association with connective tissue disease, occupational ILD, or chronic hypersensitivity pneumonitis. Chest CTs will be centrally read for eligibility
  • 40% predicted less than or equal to (<=) forced vital capacity (FVC) <= 80% predicted at screening
  • At least ONE of the following is required to undergo the first screening visit: Documented diagnostic right heart catheterization (RHC) within 18 months of screening with mean pulmonary arterial pressure (mPAP) >= 25 millimeters of mercury (mm Hg), pulmonary capillary wedge pressure (PCWP) <=15 mm Hg, and pulmonary vascular resistance (PVR) >=4 Wood units; Documented echocardiogram (ECHO) within 18 months of screening with right ventricular (RV) (or pulmonary artery) systolic pressure >46 mm Hg or tricuspid annular plane systolic excursion (TAPSE)/ systolic pulmonary artery pressure (SPAP) <=0.38 and absence of clinically significant left ventricular dysfunction as assessed by the investigator

Exclusion criteria

  • Participants have a confirmed or suspected diagnosis of pulmonary hypertension in World Health Organization (WHO) Group 1, WHO Group 2, WHO Group 4, or WHO Group 5
  • Participants have received phosphodiesterase type 5 inhibitors, endothelin receptor antagonists, soluble guanylate cyclase stimulators, intravenous (IV) or subcutaneous (SC) prostacyclin analogues within 30 days before the first screening visit, or sotatercept within 180 days before the first screening visit
  • Participants have any type of pulmonary and cardiovascular comorbidities as defined n protocol
  • Participants who are taking disease-modifying therapy for the underlying interstitial lung disease (ILD) (anti-fibrotics, immunosuppressives, and anti-inflammatory medications) who are not on stable doses for >30 days before the first screening visit or have initiated new ILD-directed therapies within 90 days before the first screening visit

Treatment and study plan

TX000045

Drug

Subcutaneous Injection.

Primary outcomes

  1. Mean Change from Baseline in PVR up to 16 Weeks

    Time frame: Baseline up to 16 weeks

  2. Number of Participants with Adverse Events (AEs), Adverse Events of Special Interest (AESIs) and Serious Adverse Events (SAEs)

    Time frame: Baseline up to 21 weeks

  3. Number of Participants with Clinically Significant Changes from Baseline in Safety Laboratory Assessments, 12-Lead Electrocardiogram (ECG) Assessments and Vital Sign Assessments

    Time frame: Baseline up to 21 weeks

Secondary outcomes

  1. Mean Change from Baseline in Mean Pulmonary Arterial Pressure (mPAP) up to 21 Weeks

    Time frame: Baseline up to 21 weeks

  2. Mean Change from Baseline in Hemodynamic Parameter: Pulmonary Capillary Wedge Pressure (PCWP)

    Time frame: Baseline up to 21 weeks

  3. Mean Change from Baseline in Hemodynamic Parameter: Cardiac Output (CO)

    Time frame: Baseline up to 21 weeks

  4. Mean Change from Baseline in Hemodynamic Parameter: Stroke Volume (SV)

    Time frame: Baseline up to 21 weeks

  5. Mean Change from Baseline in Resting Arterial Oxygen Saturation (SpO2) up to 21 Weeks

    Time frame: Baseline up to 21 weeks

  6. Mean Change from Baseline in Supplemental Oxygen Requirement (L/min) up to 21 Weeks

    Time frame: Baseline up to 21 weeks

  7. Mean Change from Baseline in the Nadir of the SpO2 During the 6-minute walk test (6MWT) up to 21 Weeks

    Time frame: Baseline up to 21 weeks

  8. Mean Change from Baseline in Oxygen Saturation (SpO2)at 1, 2, and 3 Minutes after Completion of the 6-MWT up to 21 Weeks

    Time frame: Baseline up to 21 weeks

  9. Mean Change from Baseline in Distance Walked During the 6MWT at Which an Absolute Decrease of SpO2>4% for At least 15 Second

    Time frame: Baseline up to 21 weeks

Study contacts

Contact information is provided by the study sponsor or research team.

Clinical Trials

CONTACT

[email protected]

+1 339 337 4053

Sponsors and collaborators

Lead sponsor

Tectonic Operating Company, Inc.

Industry

Registry information

Official study title

An Open-Label Study to Assess the Hemodynamic Effect and the Safety of TX000045 After 16 Weeks of Treatment in Participants With Pulmonary Hypertension Due to Interstitial Lung Disease

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Mar 16, 2026
Registry last updated
Jul 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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