Hypertension, Pulmonary, Lung Diseases, Interstitial
Conditions
Keywords
Interstitial lung disease, pulmonary vascular resistance
Brief 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.
Interventions
DRUGTX000045
Subcutaneous Injection.
Sponsors
Tectonic Operating Company, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 Assessments | Baseline up to 21 weeks |
| Mean Change from Baseline in PVR up to 16 Weeks | Baseline up to 16 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Mean Change from Baseline in Hemodynamic Parameter: Pulmonary Capillary Wedge Pressure (PCWP) | Baseline up to 21 weeks |
| Mean Change from Baseline in Hemodynamic Parameter: Cardiac Output (CO) | Baseline up to 21 weeks |
| Mean Change from Baseline in Hemodynamic Parameter: Stroke Volume (SV) | Baseline up to 21 weeks |
| Mean Change from Baseline in Resting Arterial Oxygen Saturation (SpO2) up to 21 Weeks | Baseline up to 21 weeks |
| Mean Change from Baseline in Supplemental Oxygen Requirement (L/min) up to 21 Weeks | Baseline up to 21 weeks |
| Mean Change from Baseline in the Nadir of the SpO2 During the 6-minute walk test (6MWT) up to 21 Weeks | Baseline up to 21 weeks |
| Mean Change from Baseline in Oxygen Saturation (SpO2)at 1, 2, and 3 Minutes after Completion of the 6-MWT up to 21 Weeks | Baseline up to 21 weeks |
| Mean Change from Baseline in Distance Walked During the 6MWT at Which an Absolute Decrease of SpO2>4% for At least 15 Second | Baseline up to 21 weeks |
| Mean Change from Baseline in Mean Pulmonary Arterial Pressure (mPAP) up to 21 Weeks | Baseline up to 21 weeks |
Countries
Poland, Romania, Serbia, South Korea, Spain, United States
Contacts
CONTACTClinical Trials
Outcome results
None listed