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

July 24, 2026 updated by: Tectonic Operating Company, Inc.

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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
25

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Poland
      • Krakow, Poland, 31-202
        • Not yet recruiting
        • Krakow
      • Lublin, Poland, 20-950
        • Not yet recruiting
        • Lublin
      • Wroclaw, Poland, 50-556
        • Not yet recruiting
        • Wroclaw
  • Romania
      • Bucharest, Romania, 50159
        • Not yet recruiting
        • Bucharest
  • Serbia
      • Belgrade, Serbia, 11000
        • Not yet recruiting
        • Belgrade
      • Kamenitz, Serbia, 21204
        • Not yet recruiting
        • Sremska Kamenica
      • Niš, Serbia, 18000
        • Not yet recruiting
        • Niš
  • South Korea
      • Gyeonggi-do, South Korea, 14353
        • Not yet recruiting
        • Gyeonggi-Do
      • Seoul, South Korea, 05505
        • Not yet recruiting
        • Seoul
  • Spain
      • Barcelona, Spain, 08002
        • Not yet recruiting
        • Barcelona
      • Madrid, Spain, 28046
        • Not yet recruiting
        • Madrid
      • Santander, Spain, 39011
        • Not yet recruiting
        • Santander
  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85020
        • Recruiting
        • Phoenix
    • California
      • San Francisco, California, United States, 94143
        • Recruiting
        • San Francisco
    • Idaho
      • Idaho Falls, Idaho, United States, 83706
        • Not yet recruiting
        • Idaho
    • Michigan
      • Allen Park, Michigan, United States, 48101
        • Not yet recruiting
        • Allen Park

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Mean Change from Baseline in PVR up to 16 Weeks
Time Frame: Baseline 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)
Time Frame: Baseline up to 21 weeks
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
Time Frame: Baseline up to 21 weeks
Baseline up to 21 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Mean Change from Baseline in Mean Pulmonary Arterial Pressure (mPAP) up to 21 Weeks
Time Frame: Baseline up to 21 weeks
Baseline up to 21 weeks
Mean Change from Baseline in Hemodynamic Parameter: Pulmonary Capillary Wedge Pressure (PCWP)
Time Frame: Baseline up to 21 weeks
Baseline up to 21 weeks
Mean Change from Baseline in Hemodynamic Parameter: Cardiac Output (CO)
Time Frame: Baseline up to 21 weeks
Baseline up to 21 weeks
Mean Change from Baseline in Hemodynamic Parameter: Stroke Volume (SV)
Time Frame: Baseline up to 21 weeks
Baseline up to 21 weeks
Mean Change from Baseline in Resting Arterial Oxygen Saturation (SpO2) up to 21 Weeks
Time Frame: Baseline up to 21 weeks
Baseline up to 21 weeks
Mean Change from Baseline in Supplemental Oxygen Requirement (L/min) up to 21 Weeks
Time Frame: Baseline 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
Time Frame: Baseline 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
Time Frame: Baseline 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
Time Frame: Baseline up to 21 weeks
Baseline up to 21 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Tectonic Operating Company, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 1, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 21, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 11, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 27, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 10, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 16, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 27, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 24, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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