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RecruitingPhase 2

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

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years to 80 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests TX000045 in people with high blood pressure in the lungs caused by interstitial lung disease, a disease that scars the lungs. It will check how the drug affects resistance to blood flow in the lungs. It will also check safety and how well people tolerate the drug.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • A chest CT scan from the past 12 months must show scarring in at least 10% of the lung tissue. The study's central team will review the scan.
  • The lung disease must be one of the types listed in the study, such as disease linked to connective tissue disease, workplace exposure, or long-term reactions to inhaled substances.
  • A breathing test called FVC must be 40% to 80% of the expected value at screening. This test measures how much air you can force out after a deep breath.
  • To start screening, you must have one of the two heart tests below, done within the past 18 months.
  • A right heart catheter test, which measures pressure using a thin tube, must show average lung artery pressure of at least 25 mm Hg, wedge pressure of 15 mm Hg or less, and resistance to blood flow of at least 4 Wood units.
  • Or, a heart ultrasound must show right heart or lung artery pumping pressure above 46 mm Hg, or a heart movement-to-lung pressure ratio called TAPSE/SPAP of 0.38 or less. The study doctor must also find no major problem with how the left side of the heart works.

Who can't join

  • You have, or may have, another type of high blood pressure in the lungs classified as WHO Group 1, 2, 4, or 5.
  • Within 30 days before the first screening visit, you used certain lung blood pressure drugs: PDE5 inhibitors, endothelin receptor blockers, soluble guanylate cyclase stimulators, or prostacyclin-like drugs given into a vein or under the skin.
  • You used sotatercept within 180 days before the first screening visit.
  • You have other lung, heart, or blood vessel conditions that are not allowed by the study rules.
  • You take drugs to treat the underlying lung disease, but your doses have not been stable for more than 30 days before the first screening visit. These include drugs for scarring, immune system activity, or inflammation.
  • You started a new treatment for interstitial lung disease within 90 days before the first screening visit.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

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

Study sites (4)

AZ

CA

ID

MI