Not Yet RecruitingPhase 2

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

United States, Poland, Romania25 participantsStarted 2026-03-30

Plain-language summary

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.

Who can participate

Age range18 Years – 80 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 ty…

What they're measuring

Mean Change from Baseline in PVR up to 16 Weeks

Timeframe: Baseline up to 16 weeks

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

Timeframe: 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 Assessments

Timeframe: Baseline up to 21 weeks

Trial details

NCT IDNCT07473700

SponsorTectonic Operating Company, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2027-11-21

Contact for this trial

Clinical Trials

+1 339 337 4053 ClinicalTrials@tectonictx.com

View on ClinicalTrials.gov More Hypertension, Pulmonary trials

Who can participate

Age range18 Years – 80 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Mean Change from Baseline in PVR up to 16 Weeks

Timeframe: Baseline up to 16 weeks

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

Timeframe: 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 Assessments

Timeframe: Baseline up to 21 weeks