Pulmonary Hypertension Associated with Interstitial Lung Disease
Conditions
Sponsors
Horiguchi Tatsuya
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Ability to provide written informed consent prior to participation in the trial, which includes the ability to comply with the requirements and restrictions listed in the informed consent form (ICF). Participants must be able to read, comprehend, and write at a level sufficient to complete trial-related materials 2. Adult male or female participants 18 to 80 years of age at the time the ICF is signed 3. A confirmed diagnosis of the following WHO Group 3 PH based on computed tomography imaging, which demonstrates the following evidence of ILD performed within 6 months prior to starting the Treatment Period: a. ILD b. CPFE: only allowed for participants with 15% or less emphysema, and the extent of the ILD must be greater than that of the emphysema. Participants may have any form of ILD (including IIP, IPF, and connective tissue disease) or CPFE 4. Results of the RHC within 35 days prior to Day 1 and meet all of the following criteria: a. Participants receiving treatment with endothelin receptor antagonists, phosphodiesterase type 5 inhibitors, soluble guanylate cyclase stimulators, prostacyclin analogs or prostacyclin receptor agonists, and/or calcium channel blockers are eligible only if on a stable dose for at least 90 days prior to RHC at baseline and throughout the Screening Period. For infusion prostacyclin analogs, dose adjustment based on the participant's body weight is allowed per medical practice. b. Participants on chronic medication for underlying lung disease (ie, pirfenidone, etc.) are eligible only if on a stable dose for at least 90 days prior to RHC at baseline and throughout the Screening Period c. Participants receiving treatment with oxygen therapy are eligible only if beginning for at least 30 days prior to RHC at baseline and throughout the Screening Period, and on a stable dose of oxygen for 30 minutes before RHC 5. Valid 6MWD 6. Women of childbearing potential (WOCBP) must have a negative pregnancy test before receiving the trial treatment and must agree to use contraception from the Screening Visit to at least 30 days after the last dose of the trial treatment. Male participants who could potentially cause pregnancy must agree to use contraception from the Screening Visit to at least 90 days after the last dose of the trial treatment to avoid pregnancy in their partners 7. Able to complete the scheduled visits and follow the instructions of the investigator
Exclusion criteria
Exclusion criteria: 1. Have a diagnosis of PAH or PH for reasons other than WHO Group 3 PH-ILD as outlined in inclusion criterion 3 2. Have evidence of clinically significant left-sided heart disease, as defined by: a. LVEF 6 L/min of oxygen supplementation by any mode of delivery at rest at baseline 4. Moderate or severe liver, renal, blood, or psychiatric disease: a. Moderate and severe hepatic impairment by the Child-Pugh scoring system (Class B and Class C) b. Moderate and severe renal impairment by estimated glomerular filtration rate (eGFR) =20 pack-years smoking 15. Participants who are pregnant, breastfeeding, or planning to become pregnant during the time of trial participation 16. Use of dual platelet inhibitor therapy 17. Severe acute or chronic medical or laboratory abnormality that may increase the risk associated with trial participation or trial treatment administration 18. Have a history of allergies to the excipients in the trial treatment 19. Known human immunodeficiency virus (HIV) positive status 20. Active hepatitis due to hepatitis B virus or hepatitis C virus 21. Use of any protocol prohibited medications. 22. Receipt of any live vaccine within 4 weeks prior to the first dose of trial treatment or expected need for live vaccination during trial participation, including at least 4 weeks after the last dose of trial treatment 23. The investigator has judged the participant as unwilling or unable to comply with the protocol 24. Other concurrent disease and/or medical condition that, in the judgment of the investigator, may put the participant at risk or may influence the results of the trial or the participant's ability to complete the entire duration of the trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Change in pulmonary vascular resistance (PVR) at week 24 2. Number of participants who experienced an adverse event (AE) up to approximately 24 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Change in hemodynamic parametersincluding mean right atrium pressure, mean pulmonary arterial pressure, cardiac index, PVR index, total peripheral resistance, mixed venous oxygen saturation, stroke volume index, and pulmonary artery compliance at Week 24. 2. Change in 6-minute walk distance (6MWD) at weeks 12 and 24 3. Change in Borg dyspnea scale at Week 12 and 24 4. Change in Word Health Organization Functional Classification (WHO FC) at weeks 12 and 24 5. Change in echocardiogram at weeks 12 and 24 6. Change in The King's Brief Interstitial Lung Disease (KBILD) at weeks 12 and 24 | — |
Countries
Argentina, Belgium, Colombia, France, Germany, Greece, Israel, Italy, Japan, Mexico, Portugal, Republic of Korea, Serbia, Spain, Taiwan, Province of China, Turkey, United Kingdom, United States
Contacts
Public ContactOperations Clinical
Nippon Shinyaku Co., Ltd.
Outcome results
None listed