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NCT07473700PHASE2Recruiting

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

Tectonic Operating Company, Inc.

Start Date

8/1/2026

Completion Date

12/11/2027

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.

Eligibility Criteria

Age Range: 18 years to 80 years

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

Interventions

DRUG

TX000045

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Conditions

Hypertension, PulmonaryLung Diseases, Interstitial

Locations

Phoenix

Phoenix, Arizona 85020

United States

San Francisco

San Francisco, California 94143

United States

Idaho

Idaho Falls, Idaho 83706

United States

Allen Park

Allen Park, Michigan 48101

United States

Krakow

Krakow, 31-202

Poland

Lublin

Lublin, 20-950

Poland

Wroclaw

Wroclaw, 50-556

Poland

Bucharest

Bucharest, 50159

Romania

Belgrade

Belgrade, 11000

Serbia

Sremska Kamenica

Kamenitz, 21204

Serbia

Niš

Niš, 18000

Serbia

Gyeonggi-Do

Gyeonggi-do, 14353

South Korea

Seoul

Seoul, 05505

South Korea

Barcelona

Barcelona, 08002

Spain

Madrid

Madrid, 28046

Spain

Santander

Santander, 39011

Spain