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

NCT07473700 · Tectonic Operating Company, Inc.
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Official title
An Open-Label Study to Assess the Hemodynamic Effect and the Safety of TX000045 After 16 Weeks of Treatment in Participants With Pulmonary Hypertension Due to Interstitial Lung Disease
About this study
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
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
Study design
Enrollment target: 25 participants
Allocation: na
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2026-10
Estimated completion: 2027-12-11
Last updated: 2026-09-08
Interventions
Drug: TX000045
Primary outcomes
  • Mean Change from Baseline in PVR up to 16 Weeks (Baseline up to 16 weeks)
  • 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)
Sponsor
Tectonic Operating Company, Inc. · industry
Contacts & investigators
ContactClinical Trials · contact · ClinicalTrials@tectonictx.com · +1 339 337 4053
All locations (16)
PhoenixRecruiting
Phoenix, Arizona, United States
San FranciscoRecruiting
San Francisco, California, United States
IdahoNot Yet Recruiting
Idaho Falls, Idaho, United States
Allen ParkNot Yet Recruiting
Allen Park, Michigan, United States
KrakowNot Yet Recruiting
Krakow, Poland
LublinNot Yet Recruiting
Lublin, Poland
WroclawNot Yet Recruiting
Wroclaw, Poland
BucharestNot Yet Recruiting
Bucharest, Romania
BelgradeNot Yet Recruiting
Belgrade, Serbia
Sremska KamenicaNot Yet Recruiting
Kamenitz, Serbia
NišNot Yet Recruiting
Niš, Serbia
Gyeonggi-DoNot Yet Recruiting
Gyeonggi-do, South Korea
SeoulNot Yet Recruiting
Seoul, South Korea
BarcelonaNot Yet Recruiting
Barcelona, Spain
MadridNot Yet Recruiting
Madrid, Spain
SantanderNot Yet Recruiting
Santander, Spain
Study of TX000045 in Participants With Pulmonary Hypertension Due to Interstitial Lung Disease · TrialPath