Not Yet RecruitingPhase 2

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

177 participantsStarted 2026-07-01

Plain-language summary

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)

Who can participate

Age range18 Years – 80 Years

SexALL

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Inclusion criteria

✓. 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
✓. 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.
✓. 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
✓. 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

Exclusion criteria

✕. 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
✕. Have mental disorders or other conditions that make it difficult to follow the protocol

What they're measuring

Change in pulmonary vascular resistance (PVR) at week 24

Timeframe: From baseline to week 24

Number of participants who experienced an adverse event (AE) up to approximately 24 weeks.

Timeframe: From baseline to week 24

Trial details

NCT IDNCT07441278

SponsorNS Pharma, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2028-09-14

View on ClinicalTrials.gov More Pulmonary Hypertension Associated With Interstitial Lung Disease (PH-ILD) trials