A Phase 2, Randomized, Double-Blind, Placebo-Controlled Dose Finding Trial to Evaluate the Efficacy and Safety of Orally Administered NS-863 in Participants with Pulmonary Hypertension Associated with Interstitial Lung Disease (PH-ILD)
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
177
NS-863 is an orally administered drug.
NS-863 is an orally administered drug.
An orally administered NS-863 matching placebo.
Change in pulmonary vascular resistance (PVR) at week 24
PVR is a hemodynamic variable of pulmonary circulation measured by right heart catheterization (RHC).
Time frame: From baseline to week 24
Number of participants who experienced an adverse event (AE) up to approximately 24 weeks.
An AE is any untoward medical occurrence in a study participant administered a study drug, which did not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the study drug. whether or not it was considered related to the study drug.
Time frame: From baseline to week 24
Change in hemodynamic parameters at week 24
The hemodynamic parameters include mean right atrium pressure, mean pulmonary arterial pressure, systolic pulmonary artery pressure, diastolic pulmonary arterial pressure, cardiac output, pulmonary artery wedge pressure, stroke volume, and mixed venous oxygen saturation. The hemodynamic parameters will be used to calculate PVR, cardiac index, PVR index, total peripheral resistance, stroke volume index, and pulmonary artery compliance.
Time frame: From baseline to week 24
Change in 6-minute walk distance (6MWD) at weeks 12 and 24
The 6MWD is the distance walked in 6 minutes as a measure of functional capacity. This will be assessed using the 6-minute walk test (6MWT).
Time frame: From baseline to weeks 12 and 24
Change in Borg dyspnea scale at week 12 and 24
Borg dyspnea scale is a measure used to assess an individual's exertion level during physical activity after the 6MWT.
Time frame: From baseline to weeks 12 and 24
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Change in Word Health Organization Functional Classification (WHO FC) at weeks 12 and 24
The WHO FC describes the severity of symptoms and limitations in physical activity according to the following classes: * Class I: No symptoms and no limitation in ordinary physical activity. * Class II: Mild symptoms and slight limitation during ordinary activity. * Class III: Marked limitation in activity due to symptoms, even during less-than-ordinary activity. * Class IV: Severe symptoms experienced at rest, with inability to carry out any physical activity without discomfort.
Time frame: From baseline to weeks 12 and 24
Change in echocardiogram at weeks 12 and 24
An echocardiogram (echo) is a noninvasive, radiation-free ultrasound test that uses sound waves to produce moving images of the heart's structure, valves, and blood flow.
Time frame: From baseline to weeks 12 and 24
Change in The King's Brief Interstitial Lung Disease (KBILD) at weeks 12 and 14.
The KBILD questionnaire measures the impact of interstitial lung disease (ILD) on a participant's daily life and overall well-being and consists of 15 items that participants will self-complete, covering 3 domains: psychological, breathlessness and activities, and chest symptoms.
Time frame: From baseline to weeks 12 and 24