Ignite Creation Date:
2024-07-17 @ 11:58 AM
Last Modification Date:
2024-10-26 @ 3:33 PM
Study NCT ID:
NCT06475781
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-28
First Post:
2024-06-12
Brief Title:
Study to Evaluate Safety and Efficacy of Mirivadelgat in PH-ILD
Sponsor:
Foresee Pharmaceuticals Co Ltd
Organization:
Foresee Pharmaceuticals Co Ltd
Study Overview
Official Title:
A Multinational Phase 2 Randomized Double-Blinded Placebo-Controlled Multiple-Dose Study to Evaluate the Safety and Efficacy of Mirivadelgat an Aldehyde Dehydrogenase 2 Activator in Patients With Pulmonary Hypertension Associated With Interstitial Lung Disease PH-ILD
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
WINDWARD
Brief 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
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
Detailed Description:
The study is a phase 2 multinational double-blind 3-arm study to evaluate the safety and efficacy of mirivadelgat an aldehyde dehydrogenase 2 activator in adult subjects aged 18 to 85 years with PH-ILD Subjects must have a confirmed diagnosis of ILD as defined by the American Thoracic Society ATS European Respiratory Society ERS Japanese Respiratory Society JRS andor Latin American Thoracic Society ALAT guidelines Raghu 2018 The diagnosis is based on a HRCT either performed at screening or within 180 days prior to screening or a historical surgical biopsy or other appropriate tissue sampling eg cryobiopsy and an RHC performed at screening Subjects who also have connective tissue disorders can comprise up to 20 of the study population
To be eligible for the study a subject must be willing to undergo a Right Heart Catheterization RHC during screening and at the Week 12 Visit at the end of study treatment Subjects on chronic treatment for underlying pulmonary diseases must be on a stableoptimized dose for 30 days prior to screening and have been receiving treatment for 90 days prior to screening
The study will enroll approximately 126 subjects assuming a drop-out rate of 20 to obtain 99 evaluable subjects 33 evaluable subjects in each cohort
Study visits will include a Screening Visit Visit 2 Study Day 1 Weeks 2 3 4 6 810 and 12 Visits 3 days and a safety Follow-up Visit 3 days after the Week 12 Visit Visits on Weeks 2 3 6 and 10 will be conducted by phone calls
To be eligible for the study a subject must be willing to undergo a Right Heart Catheterization RHC during screening and at the Week 12 Visit at the end of study treatment Subjects on chronic treatment for underlying pulmonary diseases must be on a stableoptimized dose for 30 days prior to screening and have been receiving treatment for 90 days prior to screening
The study will enroll approximately 126 subjects assuming a drop-out rate of 20 to obtain 99 evaluable subjects 33 evaluable subjects in each cohort
Study visits will include a Screening Visit Visit 2 Study Day 1 Weeks 2 3 4 6 810 and 12 Visits 3 days and a safety Follow-up Visit 3 days after the Week 12 Visit Visits on Weeks 2 3 6 and 10 will be conducted by phone calls
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None