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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Hypertension, Pulmonary; Lung Diseases, Interstitial
• Intervention / Treatment: Drug: TX000045

• Study Type: Interventional
• Enrollment (Estimated): 25
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Clinical Trials; Phone Number: +1 339 337 4053; Email: ClinicalTrials@tectonictx.com

Study Locations

• Poland
  • Krakow, Poland, 31-202
    • Krakow
• Romania
  • Bucharest, Romania, 022328
    • Bucharest
• Serbia
  • Belgrade, Serbia, 11000
    • Belgrade
  • Niš, Serbia, 18000
    • Niš
• Spain
  • Barcelona, Spain, 08002
    • Barcelona
• United States
  • Arizona
    • Scottsdale, Arizona, United States, 85258
      • Scottsdale, Arizona

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: TX000045 300 mg; Participants will receive subcutaneous (SC) injection of TX000045 at a dose of 300 milligrams (mg) every 4 weeks (Q4W) from Week 1 up to Week 13.	Drug: TX000045; Subcutaneous Injection.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Time Frame
Mean Change from Baseline in Mean Pulmonary Arterial Pressure (mPAP) up to 21 Weeks	Baseline up to 21 weeks
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

Collaborators and Investigators

• Sponsor: Tectonic Operating Company, Inc.

Study record dates

Study Major Dates

• Study Start (Estimated): March 30, 2026
• Primary Completion (Estimated): November 21, 2027
• Study Completion (Estimated): December 11, 2027

Study Registration Dates

• First Submitted: February 27, 2026
• First Submitted That Met QC Criteria: March 10, 2026
• First Posted (Actual): March 16, 2026

Study Record Updates

• Last Update Posted (Actual): March 16, 2026
• Last Update Submitted That Met QC Criteria: March 10, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Interstitial lung disease; pulmonary vascular resistance
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Respiratory Tract Diseases; Lung Diseases; Hypertension; Lung Diseases, Interstitial; Hypertension, Pulmonary
• Other Study ID Numbers: TX000045-004

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No