Study to Evaluate Safety and Efficacy of Mirivadelgat in PH-ILD (Windward)
ConditionGroup 3 Pulmonary Hypertension
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-85
SponsorForesee Pharmaceuticals Co., Ltd.
About this trial
The goal of this clinical trial is to see if mirivadelgat will work in participants with Pulmonary Hypertension Associated with Interstitial Lung Disease (PH-ILD). It will also learn about the safety of mirivadelgat. The main question it aims to answer is if mirivadelgat will improve pulmonary vascular resistance (PVR). Pulmonary vascular resistance is a way to measure blood flow in the lungs.
Researchers will compare mirivadelgat to a placebo (a look-alike capsule that contains no drug) to see if mirivadelgat works to improve the symptoms of PH-ILD. The symptoms of PH-ILD that are being looked at are exercise tolerance, heart function, and general well-being.
Participants will:
Take mirivadelgat or a placebo once a day for 12 weeks
Visit the clinic once every 4 weeks for checkups and tests
Receive phone calls every one or two weeks to check on how things are going
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
A clinical diagnosis of PH-ILD.
Participant voluntarily gives informed consent.
Male or female participants aged between 18 and 85 years at the time of signing informed consent.
Participants must agree to practice protocol-defined birth control during the study period, unless they meet criteria for not being of childbearing potential.
Disqualifiers
Participant 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, untreated/inadequately treated obstructive sleep apnea, human immunodeficiency virus (HIV), methamphetamine or anorexigenic drug use, and other conditions of the WHO Group 1, 2, 4, and 5 classifications.
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).
Trial design
Design model
Parallel
Treatments tested in this trial
Mirivadelgat
DrugSelective aldehyde dehydrogenase 2 (ALDH2) activator
placebo
Drugplacebo
Treatment groups
126 Participants
are divided into 3 treatment groupsGroup A: 150 mg mirivadelgatExperimental treatment 1 intervention
Group B: 300 mg mirivadelgatExperimental treatment 1 intervention
Group C: placeboPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Pulmonary Vascular Resistance (PVR)
The mean change from baseline to Week 12 in PVR assessed by right heart catheterization (RHC) for mirivadelgat vs. placebo.
Time frame
12 weeksSecondary outcomes
1
6-minute walk distance
The mean change from baseline to Week 12 in the 6-minute walk distance
Time frame
12 weeks2
Time to clinical deterioration from baseline to Week 12 for any of the following ADJUDICATED clinical events
* Death (all-cause mortality). * Hospital admission greater than 24 hours due to worsening of pulmonary hypertension. * Worsening of pulmonary hypertension resulting in the need for lung transplant or balloon atrial septostomy. * Initiation of parenteral prostanoid therapy, initiation of oxygen therapy, initiation of any other pulmonary hypertension-specific therapies, or need for an increase of diuretics for more than 4 weeks due to worsening of pulmonary hypertension. * Disease progression. * A decrease of more than 15% from the baseline in the 6-minute walk distance test combined with World Health Organization (WHO) functional class III or IV symptoms at 2 consecutive visits separated by at least 7 days.
Time frame
12 weeks3
Long-term prognostic risk factors
The mean change from baseline to Week 12 of long-term prognostic risk factors of plasma/serum N-terminal pro-brain natriuretic peptide (NT-ProBNP), C-terminal procollagen I (PICP), N-terminal procollagen I (NICP or PINP), and N-terminal procollagen III (NIIICP or PIIINP).
Time frame
12 weeks4
Patient-reported outcome measures (PROMS): (SF)-36v2
The change from baseline to Week 12 in the Short Form (SF)-36v2 Health Survey with Scale 0 to 100 (mean is 50), 0 is worst, 100 is best
Time frame
12 weeksOther outcomes
1
Inflammatory markers
The mean change in concentration of inflammatory markers interleukin-6 (IL-6), high-sensitivity C-reactive protein (HS-CRP), and tumor necrosis factor- α (TNF-α) from baseline to Week 12.
Time frame
12 weeks2
Change in Biomarkers
The mean change in biomarkers related to fibrogenesis, inflammation, tissue destruction, and epithelial damage, including but not limited to PRO-C3, PRO-C6, C1M, C3M, C6M, C4Malph3, VICM, and CC16-HNE, from baseline to Week 12
Time frame
Week 123
Cardiac MRI fibrosis score
The mean change in cardiac MRI fibrosis score assessed by cardiac MRI gadolinium enhancement from baseline to Week 12 with a continuous variable that is not presented on a scale (only for subjects who have no contraindication to MRI procedure).
Time frame
12 weeks4
Quantitative ILD features
The change in Quantitative ILD features \[i.e., Ground glass (QGC), Lung fibrosis (QLF), and Honeycombing (QHC)\] assessed by HRCT scan from baseline to Week 12.
Time frame
12 weeksSponsors and contacts
Click on the lead sponsor to view all of their trials.
Foresee Pharmaceuticals Co., Ltd.
Lead sponsor
QPS Holdings LLC
Collaborator
Source ClinicalTrials.gov