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

NCT07473700 | Not Yet Recruiting Phase 2 FDA Drug

• 1 other identifier: TX000045-004
• Study Type: interventional
• Target: 25
• Locations: 5 countries
• Sites: 6

Brief Summary

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.

Conditions

Hypertension, Pulmonary; Lung Diseases, Interstitial

Keywords

Interstitial lung disease; pulmonary vascular resistance

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (9)

• 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

Study Arms (1)

TX000045 300 mg

EXPERIMENTAL

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

Interventions

TX000045 DRUG

Subcutaneous Injection.

TX000045 300 mg

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• % 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Tectonic Operating Company, Inc.: lead

Study Sites (6)

Scottsdale, Arizona

Scottsdale, Arizona, 85258, United States

Location

Krakow

Krakow, 31-202, Poland

Location

Bucharest

Bucharest, 022328, Romania

Location

Belgrade

Belgrade, 11000, Serbia

Location

Niš

Niš, 18000, Serbia

Location

Barcelona

Barcelona, 08002, Spain

Location

MeSH Terms

Conditions

Hypertension, Pulmonary; Lung Diseases, Interstitial

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Hypertension; Vascular Diseases; Cardiovascular Diseases

Central Study Contacts

Clinical Trials

CONTACT

+1 339 337 4053; ClinicalTrials@tectonictx.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 27, 2026
• First Posted: March 16, 2026
• Study Start: March 30, 2026
• Primary Completion (Estimated): November 21, 2027
• Study Completion (Estimated): December 11, 2027
• Last Updated: March 16, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

RO (1); PL (1); SE (2); ES (1); US (1)