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A Clinical Trial of NS-863 in Participants With Pulmonary Hypertension Associated With Interstitial Lung Disease (PH-ILD)

ConditionPulmonary Hypertension Associated With Interstitial Lung Disease (PH-ILD)
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-80
SponsorNS Pharma, Inc.

About this trial

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)

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Adult male or female participants 18 to 80 years of age at the time the ICF is signed

ILD

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

Disqualifiers

Have a diagnosis of PAH or PH for reasons other than WHO Group 3 PH-ILD as outlined in inclusion criterion 3

Receiving > 6 L/min of oxygen supplementation by any mode of delivery at rest at baseline

Moderate and severe hepatic impairment by the Child-Pugh scoring system (Class B and Class C)

Moderate and severe renal impairment by estimated glomerular filtration rate (eGFR) <60 mL/min/m2

Trial design

Design model

Parallel

Treatments tested in this trial

  • NS-863 Low Dose

    Drug

    NS-863 is an orally administered drug.

  • NS-863 High Dose

    Drug

    NS-863 is an orally administered drug.

  • Placebo

    Other intervention

    An orally administered NS-863 matching placebo.

Treatment groups

177 Participants
are divided into 3 treatment groups
Group A: NS-863 Low DoseActive comparator 1 intervention
Group B: NS-863 High DoseActive comparator 1 intervention
Group C: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

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
2

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

Secondary outcomes

1

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
2

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
3

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
4

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

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

NS Pharma, Inc.

Lead sponsor

Nippon Shinyaku Co., Ltd.

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: