No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 – 80
Sex
Any
Trial phase
Phase 2
Study type
Interventional
Purpose
Treatment
Participants needed
25 (estimated)
Sponsor
Tectonic Operating Company, Inc. · Industry
Who this trial is looking for
This trial is looking for participants with pulmonary hypertension related to interstitial lung disease. Taking part involves assessing the effects and safety of a treatment called TX000045.
Are You a Good Fit for This Trial?
Must not be takingPhosphodiesterase type 5 inhibitorsEndothelin receptor antagonistsSoluble guanylate cyclase stimulatorsIV or SC prostacyclin analoguesSotatercept
You may be able to join if
I have been diagnosed with interstitial lung disease (ILD).
I have a lung capacity between 40% and 80% of what is expected.
I have undergone a right heart catheterization or echocardiogram in the past 18 months.
You may not be able to join if
I have a diagnosis of pulmonary hypertension from certain recognized groups.
I have taken specific medications for pulmonary hypertension in the last 30 to 180 days.
I have other significant lung or heart conditions.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
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.
Trial Locations
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Status
Eligibility Criteria
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 as…
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
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