Study of TX000045 in Participants With Pulmonary Hypertension Due to Interstitial Lung Disease
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-80
SponsorTectonic Operating Company, Inc.
About this trial
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
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Single group
Treatments tested in this trial
TX000045
DrugSubcutaneous Injection.
Treatment groups
25 Participants
are divided into 1 treatment groupGroup A: TX000045 300 mgExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Mean Change from Baseline in PVR up to 16 Weeks
Time frame
Baseline up to 16 weeks2
Number of Participants with Adverse Events (AEs), Adverse Events of Special Interest (AESIs) and Serious Adverse Events (SAEs)
Time frame
Baseline up to 21 weeks3
Number of Participants with Clinically Significant Changes from Baseline in Safety Laboratory Assessments, 12-Lead Electrocardiogram (ECG) Assessments and Vital Sign Assessments
Time frame
Baseline up to 21 weeksSecondary outcomes
1
Mean Change from Baseline in Mean Pulmonary Arterial Pressure (mPAP) up to 21 Weeks
Time frame
Baseline up to 21 weeks2
Mean Change from Baseline in Hemodynamic Parameter: Pulmonary Capillary Wedge Pressure (PCWP)
Time frame
Baseline up to 21 weeks3
Mean Change from Baseline in Hemodynamic Parameter: Cardiac Output (CO)
Time frame
Baseline up to 21 weeks4
Mean Change from Baseline in Hemodynamic Parameter: Stroke Volume (SV)
Time frame
Baseline up to 21 weeksSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov