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Study of TX000045 for Pulmonary Hypertension Due to Interstitial Lung Disease

This study is testing a drug called TX000045, given as an injection under the skin, for people with pulmonary hypertension (high blood pressure in the arteries of the lungs) caused by interstitial lung disease (ILD). Researchers want to see how well TX000045 affects pulmonary vascular resistance (PVR), which is a measure of how hard your heart has to work to pump blood through your lungs. They will also be looking closely at the safety and any side effects of TX000045. You might be able to join if you are between 18 and 80 years old and have a confirmed diagnosis of ILD with fibrosis. The study aims to enroll 25 participants, but its current recruitment status is unclear.

Study design
This is an interventional study with an estimated enrollment of 25 participants. The phase of the study is not specified.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Safety will be monitored up to 21 weeks after the start of the study.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07473700

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

Recruiting
PHASE2Ages 18–80InterventionalTreatment
Tectonic Operating Company, Inc.
~25 participants
Updated 2026-07-27 on ClinicalTrials.gov
What's tested:TX000045

At a glance

Recruiting sites
2 of 16 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Mean Change from Baseline in PVR up to 16 Weeks
Measured over Baseline up to 16 weeks
+2 more outcomes measured

Conditions

Hypertension, Pulmonary
Lung Diseases, Interstitial

Explore related trials

Interstitial Lung DiseasePulmonary Hypertension

Where it's being run

16 sites across 9 states
Poland3
Serbia3
Spain3
South Korea2
Arizona1
California1
Idaho1
Michigan1

Who to contact

Clinical Trials
[email protected]
+1 339 337 4053
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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

What this trial measures

  • Mean Change from Baseline in PVR up to 16 WeeksBaseline up to 16 weeks
  • Number of Participants with Adverse Events (AEs), Adverse Events of Special Interest (AESIs) and Serious Adverse Events (SAEs)Baseline up to 21 weeks
  • Number of Participants with Clinically Significant Changes from Baseline in Safety Laboratory Assessments, 12-Lead Electrocardiogram (ECG) Assessments and Vital Sign AssessmentsBaseline up to 21 weeks