Study to Evaluate Safety and Efficacy of Mirivadelgat in PH-ILD
NCT Number: NCT06475781
Acronym: WINDWARD
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Group 3 Pulmonary Hypertension
Interventions: DRUG: Mirivadelgat|DRUG: placebo
Sponsor: Foresee Pharmaceuticals Co., Ltd.
Collaborators: QPS-Qualitix Clinical Research Co., Ltd
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 126
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-12
Completion Date: 2028-08

Summary:
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. 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

Primary Outcome Measures: Pulmonary Vascular Resistance (PVR), The mean change from baseline to Week 12 in PVR assessed by right heart catheterization (RHC) for mirivadelgat vs. placebo., 12 weeks
Secondary Outcome Measures: 6-minute walk distance, The mean change from baseline to Week 12 in the 6-minute walk distance, 12 weeks|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., 12 weeks|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)., 12 weeks|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, 12 weeks|Patient-reported outcome measures (PROMS): WIQ, The change from baseline to Week 12 in the Walking Impairment Questionnaire (WIQ) with percentage scale ranging from 0% (worst) to 100% (best), 12 weeks|Patient-reported outcome measures (PROMS): PAH-SYMPACT, The change from baseline to Week 12 in the Pulmonary Arterial Hypertension-Symptoms and Impact Questionnaire (PAH-SYMPACT) with each point scored from 0 (best) to 4 (worst), 12 weeks
Other Outcome Measures: 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., 12 weeks|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)., 12 weeks|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., 12 weeks|Risk for intervention, The Absolute Risk for intervention regarding specific events of death and stroke (CVA) (the absolute risk reduction between placebo and treatment of the composite event of death and stroke), 12 weeks|Cardiac strain, The mean change in cardiac strain assessed by contrast-enhancement echocardiogram from baseline to Week 12., 12 weeks|Change of right ventricle/left ventricle (RV/LV) size, The mean change in transthoracic echocardiography measurement of right ventricle/left ventricle (RV/LV) size, function, and strain from baseline to Week 12., 12 weeks|Pulmonary function tests (PFTs) - FEV1, The change in FEV1 from baseline to Week 12., 12 weeks|Pulmonary function tests (PFTs) - FEV1 / FVC ratio, The change in FEV1 / FVC from baseline to Week 12., 12 weeks|Pharmacokinetic (PK) parameters: T1/2, T1/2 for mirivadelgat and its active metabolite AD-835., 12 weeks|Pharmacokinetic (PK) parameters: AUC, AUC for mirivadelgat and its active metabolite AD-835., 12 weeks