Hypertension, PulmonaryPhase 2NCT07473700
Study of TX000045 in Participants With Pulmonary Hypertension Due to Interstitial Lung Disease
A Phase 2 study testing TX000045 in people with Hypertension, Pulmonary and Lung Diseases, Interstitial, run by Tectonic Operating Company, Inc. at 16 sites in 6 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Hypertension, Pulmonary, Lung Diseases, Interstitial
- What is being tested?
- TX000045
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 16 sitesin 6 countries
- Study dates
- Oct 2026to 11 Dec 2027
- Phase
- Phase 2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
16 sites in 6 countries. Contact the study team or a site near you to ask about taking part.
16 sites in 6 countries
United States4 sites, 4 recruiting
- Not yet recruiting
Allen Park
Allen Park, Michigan, 48101
- Not yet recruiting
Idaho
Idaho Falls, Idaho, 83706
- Recruiting
Phoenix
Phoenix, Arizona, 85020
- Recruiting
San Francisco
San Francisco, California, 94143
Poland3 sites, 3 recruiting
- Not yet recruiting
Krakow
Krakow, 31-202
- Not yet recruiting
Lublin
Lublin, 20-950
- Not yet recruiting
Wroclaw
Wroclaw, 50-556
Serbia3 sites, 3 recruiting
- Not yet recruiting
Belgrade
Belgrade, 11000
- Not yet recruiting
Sremska Kamenica
Kamenitz, 21204
- Not yet recruiting
Niš
Niš, 18000
Spain3 sites, 3 recruiting
- Not yet recruiting
Barcelona
Barcelona, 08002
- Not yet recruiting
Madrid
Madrid, 28046
- Not yet recruiting
Santander
Santander, 39011
South Korea2 sites, 2 recruiting
- Not yet recruiting
Gyeonggi-Do
Gyeonggi-do, 14353
- Not yet recruiting
Seoul
Seoul, 05505
About this study
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
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.
- Being tested
- TX000045
- Keywords
- Interstitial lung disease, pulmonary vascular resistance
- Medical subject headings
- Hypertension, Pulmonary, Lung Diseases, Interstitial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TX000045Drug
Subcutaneous Injection.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: TX000045 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Change from Baseline in PVR up to 16 Weeks
Measured: Baseline up to 16 weeks
Number of Participants with Adverse Events (AEs), Adverse Events of Special Interest (AESIs) and Serious Adverse Events (SAEs)
Measured: 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
Measured: Baseline up to 21 weeks
Secondary outcomes (9)
Mean Change from Baseline in Mean Pulmonary Arterial Pressure (mPAP) up to 21 Weeks
Measured: Baseline up to 21 weeks
Mean Change from Baseline in Hemodynamic Parameter: Pulmonary Capillary Wedge Pressure (PCWP)
Measured: Baseline up to 21 weeks
Mean Change from Baseline in Hemodynamic Parameter: Cardiac Output (CO)
Measured: Baseline up to 21 weeks
Mean Change from Baseline in Hemodynamic Parameter: Stroke Volume (SV)
Measured: Baseline up to 21 weeks
Mean Change from Baseline in Resting Arterial Oxygen Saturation (SpO2) up to 21 Weeks
Measured: Baseline up to 21 weeks
Mean Change from Baseline in Supplemental Oxygen Requirement (L/min) up to 21 Weeks
Measured: 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
Measured: 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
Measured: 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
Measured: Baseline up to 21 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2026
- Study startOct 2026 (estimated)
- Primary completion21 Nov 2027 (estimated)
- Study completion11 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypertension, PulmonaryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tectonic Operating Company, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07473700
- Sponsor's protocol ID
- TX000045-004
- Status last verified
- Sep 2026
- First submitted
- 27 Feb 2026
- Last updated
- 8 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No