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Assessing Hemodynamic Effect and Safety of TX000045 in Adults with Pulmonary Hypertension Secondary to Interstitial Lung Disease

Verified siteInvestigationalNo placebo

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What is this trial about?

A plain-language summary of the goals, design and what participants do

The study involves people who have Pulmonary hypertension secondary to interstitial lung disease, a condition where the blood pressure in the lungs’ arteries is too high because of scarring or inflammation in the lung tissue. The medication being tested is a new drug called TX000045, which is given as a liquid that is injected under the skin. The purpose of the study is to evaluate how this drug affects the pressure in the lung vessels and to determine whether it is safe to use in this patient group.

Participants will receive the injection regularly for a total of 16 weeks and will attend clinic visits where doctors will check their health, perform simple blood tests, and monitor heart rhythm with a standard heart‑monitoring strip (ECG). One of the key measurements is pulmonary vascular resistance, a number that shows how hard the heart has to work to push blood through the lungs. Other assessments include measuring oxygen saturation (the level of oxygen in the blood) at rest and during a 6‑minute walk test, where the distance a person can walk in six minutes is recorded and the drop in oxygen levels is tracked. Throughout the study, any side effects or unusual lab results will be recorded to assess safety.

The research process

The trial runs in 7 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Baseline assessments
After joining the study, you will undergo a series of initial examinations to establish your health status before receiving any medication.
These examinations include a review of your medical history, a physical exam, blood and urine tests, a 12‑lead electrocardiogram (ecg), and measurements of blood pressure and heart rate.
Your lung condition will be evaluated with a test that measures the pressure in the blood vessels of the lungs, known as pulmonary vascular resistance, and with a breath‑holding test that records oxygen levels (spO2).
You will also perform a 6‑minute walk test, during which you walk for six minutes while your oxygen saturation is monitored.
Step 2
First injection of tx000045
Once the baseline assessments are complete, you will receive the first dose of the study drug, identified as TX000045.
The drug is supplied as a solution for injection and is given subcutaneously (under the skin) at a dose of 300 mg.
The injection will be performed by a qualified staff member, and you will be shown how to recognize any reactions at the injection site.
Step 3
Regular dosing for 16 weeks
After the first injection, you will continue to receive the same dose of 300 mg of TX000045 on a regular schedule that will be explained by the study team.
The injections will be continued for a total treatment period of 16 weeks.
Each dosing visit will include a brief check of your injection site and a discussion of any new symptoms or side effects you may have experienced.
Step 4
Periodic safety monitoring
Throughout the 16‑week treatment period you will attend scheduled visits, typically every four weeks, for safety monitoring.
At each visit you will have blood and urine tests, an ecg, and measurements of vital signs such as blood pressure, heart rate, and body temperature.
The purpose of these tests is to detect any changes that might indicate an adverse reaction to the medication.
Step 5
Mid‑study assessments
Around the middle of the treatment period, you may undergo repeat measurements of lung blood pressure (pulmonary vascular resistance) and other heart‑function parameters to track any changes.
These assessments are performed in the same way as the baseline measurements, allowing comparison over time.
Step 6
Final functional and hemodynamic evaluations
At the end of the 16‑week treatment period, you will repeat the functional tests that were done at baseline.
This includes another 6‑minute walk test with continuous monitoring of oxygen saturation, measurement of resting oxygen requirement, and recording of any decrease in oxygen levels during the walk.
Additional measurements of lung blood pressure and related heart parameters will also be performed to determine the overall effect of the drug.
Step 7
Study completion visit
After the final assessments, you will have a concluding visit where all study results are reviewed.
The study team will discuss any adverse events that occurred, the overall safety of the medication, and the changes observed in your condition.
The medication will be discontinued at this point, and you will receive guidance on any further medical care that may be needed.

Who can join the trial?

9 criteria

Be an adult between 18 and 80 years old.
If you can become pregnant (or are a man with a partner who can become pregnant), you must agree to use a highly effective contraception method that fails less than 1 % of the time when used correctly.
Have a confirmed diagnosis of interstitial lung disease (ILD) based on a chest CT scan performed in the last 12 months that shows fibrotic (scar‑like) changes in the lungs.
Your lung function test called forced vital capacity (FVC) must be between 40 % and 80 % of the normal value for someone of your age and size.
Show evidence of pulmonary hypertension (high pressure in the lungs) from either a right‑heart catheter (RHC) done within the past 18 months that measured a mean pulmonary artery pressure (mPAP) of 25 mm Hg or higher, a pulmonary capillary wedge pressure (PCWP) of 15 mm Hg or lower, and a pulmonary vascular resistance (PVR) of 4 Wood units or more, or an echocardiogram (ECHO) done within the past 18 months that showed a right‑ventricular (RV) or pulmonary‑artery pressure above 46 mm Hg, or a TAPSE/SPAP ratio of 0.38 or less, and no important problem with the left side of the heart.
During the screening catheter test performed within 21 days before the first dose, the same pressure measurements (mPAP ≥ 25 mm Hg, PCWP ≤ 15 mm Hg, PVR ≥ 4 Wood units) must be confirmed; if the PCWP is a little higher (between 12 and 15 mm Hg), special permission is required.
Be classified by the doctor as having NYHA Class II or III, meaning you have mild to moderate limitation of physical activity because of your heart‑lung condition.
Be able to walk between 150 m and 450 m in a 6‑minute walk test (6MWD) on each of two separate screening visits.
Be able to follow the study schedule, understand the study requirements, and sign a written informed consent form.

Who cannot join the trial?

25 criteria

Having a confirmed or suspected diagnosis of pulmonary hypertension that belongs to WHO Group 1, 2, 4, or 5 (different types of high blood pressure in the lungs).
Testing positive for HIV (the virus that can cause AIDS) at the first screening visit.
Having abnormal laboratory test results that are listed as exclusion criteria in the study protocol.
Having a history of a severe allergic reaction, anaphylaxis (a very serious allergic response), or sensitivity to the study drug’s protein components or inactive ingredients.
Having already received, or planning to receive, a transplant of any organ (such as a kidney, liver, or heart).
Starting a new exercise program or increasing the intensity of an existing one within the last three months, or planning to do so during the study.
Being pregnant or breastfeeding.
Having an active cancer diagnosed within the past five years, except for certain skin cancers that have been completely removed (basal cell carcinoma, cervical carcinoma in situ, or up to two squamous cell skin cancers).
Being judged by the doctor to have a life expectancy of less than 12 months.
Having a body mass index (BMI) lower than 18 kg/m² or equal to or higher than 45 kg/m² (a measure of body weight relative to height).
Having a history of drug or alcohol misuse within the past three years, or a positive urine test for prohibited drugs (marijuana use is allowed).
Currently taking specific lung medicines listed in the study protocol that are not allowed for participants.
Receiving any vaccination, including COVID‑19 vaccine, within one week before the first dose, or planning to receive a vaccine during the study period (except seasonal flu or a COVID‑19 booster that may be given between weeks 6 and 12).
Having previously received relaxin or relaxin‑fusion proteins, including the study drug TX000045.
Having taken part in another clinical trial of an investigational drug or therapy within the last 90 days (or longer, depending on the drug’s half‑life) before the first screening visit.
Being mentally or legally unable to give consent, having significant emotional problems, or a history of serious psychiatric disorders, as judged by the investigator.
Having any illness that the investigator believes could interfere with the study results or increase the risk to the participant.
Having a condition that significantly limits the ability to walk for six minutes (the 6‑minute walk test), such as severe joint injury, arthritis, or chest‑pain related heart disease (angina).
Having other lung diseases (pulmonary comorbidities) listed in the study protocol.
Having other heart diseases (cardiovascular comorbidities) listed in the study protocol.
Taking disease‑modifying treatments for the underlying interstitial lung disease (such as anti‑fibrotic, immunosuppressive, or anti‑inflammatory drugs) that have not been at a stable dose for more than 30 days, or having started new lung‑disease therapies within the past 90 days.
Having recently used inhaled medications specified in the protocol.
Using diuretics (water pills) or supplemental oxygen without a stable dose for more than 30 days before screening.
Being hospitalized for any reason or having received intravenous drugs that support heart function (inotropes/vasopressors such as dobutamine, dopamine, norepinephrine, or vasopressin) within the past 30 days.
Having had major surgery within the past 60 days and not being fully recovered from it.

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Fundacion Para La Investigacion Biomedica Del Hospital Universitario La Paz
Responsive
Madrid, Spain
Hospital Universitario Marques De Valdecilla
Verified
Santander, Spain
Hospital Vall d’Hebron
Verified
Barcelona, Spain

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Investigated drugs

TX000045 is a medication given by a subcutaneous injection (under the skin) in a liquid form. In this study, participants with pulmonary hypertension caused by interstitial lung disease receive the drug to see how it affects the pressure in the blood vessels of the lungs. Researchers are looking at whether the medication can lower the resistance in these vessels and improve blood flow. They are also closely monitoring participants for any side effects or safety concerns while they take the medication for 16 weeks.

TX000045

What is already known about the treatment

TX000045 - It is administered as a 300 mg subcutaneous injection of a sterile solution for infusion. The drug is still investigational and is being evaluated in clinical trials, so it is not yet approved for routine use. It is being studied to treat pulmonary hypertension that occurs with interstitial lung disease by helping to lower the pressure in the lung’s blood vessels. TX000045 acts as an endothelin receptor antagonist, a type of medication that blocks a chemical signal that makes blood vessels tighten, thereby helping them relax and improve blood flow.

Investigated diseases

Pulmonary hypertension secondary to interstitial lung disease - Pulmonary hypertension secondary to interstitial lung disease is a condition where the blood pressure in the arteries of the lungs becomes elevated because of scarring or inflammation in the lung tissue. The stiffened lung tissue makes it harder for oxygen to pass into the bloodstream, which causes the small arteries to narrow and the heart to work harder to push blood through. Over time, the pressure in these vessels rises, leading to increased strain on the right side of the heart. As the underlying lung disease progresses, the pulmonary pressure typically worsens, resulting in reduced exercise tolerance and shortness of breath. The condition may evolve gradually, reflecting the ongoing damage to the lung interstitium and the heart’s response to the increased workload.