TX000045 for pulmonary hypertension from interstitial lung disease

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a Phase 2 interventional trial enrolling adults with interstitial lung disease who have pulmonary hypertension. Participants will receive TX000045 and will be monitored for changes in pulmonary vascular resistance and safety/tolerability. Eligibility requires evidence of ILD on imaging and reduced lung function, plus a recent invasive or noninvasive assessment showing PH. Study sites are in Phoenix, San Francisco, and Boise, with centrally read imaging and hemodynamic assessments. The goal is to determine if TX000045 can improve PH-ILD and be safe in this population.

Why it matters

Who can join: the full rules

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

Where it's running

• Phoenix
  Phoenix, Arizona, United States Recruiting
• San Francisco
  San Francisco, California, United States Recruiting
• Allen Park
  Allen Park, Michigan, United States Recruiting
• Wroclaw
  Wroclaw, Poland Recruiting
• Bucharest
  Bucharest, Romania Recruiting
• Belgrade
  Belgrade, Serbia Recruiting

Study contacts

• Study coordinator: Clinical Trials
• Email: ClinicalTrials@tectonictx.com
• Phone: +1 339 337 4053

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.