A Clinical Trial of NS-863 in Participants With Pulmonary 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
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
Treatments tested in this trial
- NS-863 Low Dose
- NS-863 High Dose
- Placebo
Treatment groups
177 Participants
are divided into 3 treatment groupsLocations
Sponsors and collaborators
NS Pharma, Inc.
Lead sponsor
Nippon Shinyaku Co., Ltd.
Collaborator
Source ClinicalTrials.gov