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Tests treatment safety and results for Group 3 Pulmonary Hypertension
Official title Study to Evaluate Safety and Efficacy of Mirivadelgat in PH-ILD (Windward)
ClinicalTrials.gov ID: NCT06475781
What this study is testing
What is Mirivadelgat?
Mirivadelgat is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for group 3 pulmonary hypertension.
Also referred to as FP-045.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The goal of this clinical trial is to see if mirivadelgat will work in patients with Pulmonary Hypertension Associated with Interstitial Lung Disease (PH-ILD). It will also learn about the safety of mirivadelgat.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 85
You may be able to join if
- A clinical diagnosis of PH-ILD.
- Subject voluntarily gives informed consent.
- people aged between 18 and 85 years at the time of signing informed consent.
- people must agree to practice protocol-defined birth control during the study period.
- Males with a partner of childbearing potential must practice protocol-defined birth control for the duration of treatment and at least 96 hours after...
You likely can't join if
- Medical Conditions
- Subject has another concomitant diagnosis of pulmonary hypertension not otherwise considered to be PH-ILD. This would include and is not limited to...
- Subject has evidence of clinically significant left-sided heart disease within 6 months as defined by:
- Left ventricular ejection fraction \<40% as assessed by echocardiography.
- More than mild left-sided valvulopathy (e.g., worse than mild mitral stenosis or regurgitation and worse than mild aortic stenosis or regurgitation).
- LVEDP or PCWP \>15 mmHg (or \>12 mmHg if PVR ≥4 to 6.25 Wood units).
See the full eligibility criteria
Who can join
- A clinical diagnosis of PH-ILD.
- Subject voluntarily gives informed consent.
- people aged between 18 and 85 years at the time of signing informed consent.
- people must agree to practice protocol-defined birth control during the study period.
- Males with a partner of childbearing potential must practice protocol-defined birth control for the duration of treatment and at least 96 hours after discontinuing the IP.
- Female people of childbearing of potential (including those \<1-year post menopausal) must practice protocol-defined birth control during the conduct of the study and for 30 days after the last dose of IP (males only...
- Women not of childbearing potential are defined as:
- Post-menopausal women (at least 12 months with no menses without an alternative medical cause); in women \<45 years of age, a high follicle-stimulating hormone (FSH) level in the post-menopausal range may be used to...
- Have had a hysterectomy and/or bilateral oophorectomy, bilateral salpingectomy, or bilateral tubal ligation/occlusion, at least 6 weeks prior to screening; OR
- Have a congenital or acquired condition that prevents childbearing.
- The subject has a confirmed diagnosis of any form of interstitial lung disease based on high resolution computed tomography (HRCT) of the chest within 180 days prior to screening or at screening or a historical surgical...
- people have undergone RHC during the screening period with the following documented parameters:
- Pulmonary vascular resistance (PVR) ≥4 Wood units and
- Pulmonary capillary wedge pressure (PCWP) of ≤12 mmHg [if PVR ≥4 Wood units to \<6.25 Wood units] or PCWP ≤15 mmHg [if PVR ≥6.25 Wood units] (a left ventricular end diastolic pressure [LVEDP] will be acceptable if a...
- A mean pulmonary arterial pressure (PAP) of \>20 mmHg.
- people must have a baseline 6-minute walk distance ≥100 meters and ≤500 meters.
- people agree to a repeat RHC, Chest CT, and MRI prior to study completion.
- people on chronic treatment for underlying lung disease (i.e., nintedanib or pirfenidone or immunosuppressive agents etc.) must be on a stable/optimized dose for ≥30 days prior to screening and have been receiving...
- people on supportive medications (e.g., inhalers for asthma) must be on stable doses for ≥30 days prior to screening.
- In the Investigator's opinion, the subject must be able to consent for themselves and communicate with local staff using interpreters if necessary. people must agree to attend all study visits and be contactable through...
- people must have clinical laboratory values within normal ranges or \<1.5 times the upper limit of normal (ULN) as specified by the testing laboratory.
- Pulmonary function test (PFT) showing a percent predicted forced vital capacity (FVC) \<70% of predicted and diffusion capacity of carbon monoxide (DLCO) \<70% corrected for hemoglobin (Hb) value ≥25% and ≤90% at...
- people with a prior diagnosis of connective tissue diseases, specifically systemic sclerosis (scleroderma), systemic lupus erythematosus, Sjogren's disease, polymyositis/dermatomyositis/antisynthetase syndrome...
- Negative serology test for hepatitis B surface antigen and hepatitis C antibody at Screening Visit.
What rules you out
- Medical Conditions
- Subject has another concomitant diagnosis of pulmonary hypertension not otherwise considered to be PH-ILD. This would include and is not limited to the concomitant presence of thromboembolic disease...
- Subject has evidence of clinically significant left-sided heart disease within 6 months as defined by:
- Left ventricular ejection fraction \<40% as assessed by echocardiography.
- More than mild left-sided valvulopathy (e.g., worse than mild mitral stenosis or regurgitation and worse than mild aortic stenosis or regurgitation).
- LVEDP or PCWP \>15 mmHg (or \>12 mmHg if PVR ≥4 to 6.25 Wood units).
- people must NOT have 3 or more of the following left ventricular disease/dysfunction risk factors at screening:
- Body mass index (BMI) ≥30 kg/m2.
- Uncontrolled diabetes, HbA1C \>9.5%, urine glycosuria \>1.0 g/dl, or presence of diabetic ketoacidosis
- History of significant coronary disease within 6 months of screening as demonstrated by any of the following:
- History of myocardial infarction or acute coronary syndrome (unstable angina), or
- Percutaneous coronary intervention or percutaneous transluminal angioplasty, or previous coronary artery bypass graft, or
- Evidence of coronary artery disease (\>50% stenosis in at least one major coronary artery) or abnormal nuclear stress test.
- The subject is receiving \>10 L/min of oxygen supplementation by any mode of delivery at rest.
- The subject has received any PH-approved therapy, including phosphodiesterase type 5 inhibitor, soluble guanylate cyclase inhibitor, endothelin receptor antagonist, or parenteral or oral prostacyclin therapy (excluding...
- Use of any potent inhibitors and potent inducers of cytochrome P450 3A4 (CYP3A4) (e.g., boceprevir, cobicistat, danoprevir and ritonavir, elvitegravir and ritonavir, grapefruit juice, indinavir and ritonavir...
- Recent exacerbation of underlying lung disease or active pulmonary/upper respiratory tract infection within 4 weeks of randomization.
- Any current active malignancy (this does not include localized cancers such as basal or squamous cell carcinoma of the skin). Any history of malignancy that is likely to result in mortality or require significant...
- Chronic kidney disease Stage IV or greater (i.e., eGFR ˂30 mL/min/1.73m2) or evidence of acute kidney injury.
- The subject has a history of congenital heart disease irrespective of any prior treatment of surgical intervention
- Use of tobacco, e-cigarette, nicotine, or marijuana products or significant history of drug or alcohol abuse within 6 months of screening.
- Acute pulmonary embolism within 90 days of screening.
- Participation in pulmonary rehabilitation within 90 days of screening.
- Prior or concurrent use of any investigation drug/device/therapy or participation in any investigational study with therapeutic intent within 30 days or 5 half-lives, whichever is longer before the first dose of the IP.
- BMI ≥40 kg/m2.
- Uncontrolled hypertension as evidenced by systolic blood pressure \>160 mmHg or diastolic blood pressure \>100 mmHg during the screening period. people who fail screening due to high blood pressure can be re-screened...
- Concomitant disease that confers a life expectancy of \<6 months at screening.
- The Investigator judges that the subject will be unable to fully participate in the study and complete it for any reason, including inability to comply with the study procedures and treatment of addiction or any other...
- High likelihood of lung transplantation (in the opinion of the Investigator) within 4 months after randomization.
- History of liver dysfunction, including people with moderate (Child-Pugh B) or severe (Child Pugh C) impairment or disordered coagulation.
- Female people who are pregnant or breastfeeding.
- Worse than mild untreated sleep apnea (5-14.9 events/hour). Treated sleep apnea is permitted. Other Exclusions
- History of allergic or anaphylactic reaction to mirivadelgat or to any component of the excipient.
- Previous exposure to mirivadelgat. Diagnostic Assessments
- The following laboratory parameters are excluded:
- Hemoglobin \<10 g/dL (100 g/L).
- White blood cells (WBC) \<3000/µL (\<3000/mm3).
- Platelet count \<70,000/µL (70,000/mm3).
- Estimated glomerular filtration rate (eGFR) \<30 mL/min/1.73m2 or evidence of acute kidney injury.
The study team makes the final eligibility decision.
Where it's taking place
- Hualien City, Taiwan, Taiwan
- Kaohsiung City, Taiwan, Taiwan
- Taichung, Taiwan, Taiwan
- Tainan, Taiwan, Taiwan
- Taipei, Taiwan, Taiwan
- Taoyuan City, Taiwan, Taiwan
- Kaohsiung City, Taiwan
- Taipei, Taiwan
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 85 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Hualien City, Taiwan, Taiwan; Kaohsiung City, Taiwan, Taiwan; Taichung, Taiwan, Taiwan; Tainan, Taiwan, Taiwan; Taipei, Taiwan, Taiwan; Taoyuan City, Taiwan, Taiwan and 2 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.