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

NCT07441278 | Not Yet Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: NS-863B-P2-01
• Study Type: interventional
• Target: 177
• Locations: 0 countries
• Sites: N/A

Brief 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)

Conditions

Pulmonary Hypertension Associated With Interstitial Lung Disease (PH-ILD)

Outcome Measures

Primary Outcomes (2)

• Change in pulmonary vascular resistance (PVR) at week 24

  PVR is a hemodynamic variable of pulmonary circulation measured by right heart catheterization (RHC).

  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.

  From baseline to week 24

Secondary Outcomes (6)

• Change in hemodynamic parameters at week 24

  From baseline to week 24

• Change in 6-minute walk distance (6MWD) at weeks 12 and 24

  From baseline to weeks 12 and 24

• Change in Borg dyspnea scale at week 12 and 24

  From baseline to weeks 12 and 24

• Change in Word Health Organization Functional Classification (WHO FC) at weeks 12 and 24

  From baseline to weeks 12 and 24

• Change in echocardiogram at weeks 12 and 24

  From baseline to weeks 12 and 24

Study Arms (3)

NS-863 Low Dose

ACTIVE COMPARATOR

NS-863 is an orally administered drug.

Drug: NS-863 Low Dose

NS-863 High Dose

ACTIVE COMPARATOR

NS-863 is an orally administered drug.

Drug: NS-863 High Dose

Placebo

PLACEBO COMPARATOR

An orally administered NS-863 matching placebo

Other: Placebo

Interventions

NS-863 Low Dose DRUG

NS-863 is an orally administered drug.

NS-863 Low Dose

NS-863 High Dose DRUG

NS-863 is an orally administered drug.

NS-863 High Dose

Placebo OTHER

An orally administered NS-863 matching placebo.

Placebo

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants must meet all of the following criteria to be included in the trial:
• 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
• 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:
• 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
• Results of the RHC within 35 days prior to Day 1 and meet all of the following criteria:
• 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
• Valid 6MWD
• 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
• Able to complete the scheduled visits and follow the instructions of the investigator

You may not qualify if:

• Participants meeting any of the following criteria at the Screening Visit or baseline are ineligible to participate in this trial:
• Have evidence of clinically significant left-sided heart disease, as defined by:
• a. LVEF \<40% Notes: Participants with abnormal LV function attributable entirely to impaired LV filling due to the effects of RV overload (ie, RV hypertrophy and/or dilatation) will not be excluded
• Receiving \> 6 L/min of oxygen supplementation by any mode of delivery at rest at baseline
• Moderate or severe liver, renal, blood, or psychiatric disease:
• 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
• History of clinically significant (per investigator's judgment) drug or alcohol abuse disorder within the last 6 months
• Have mental disorders or other conditions that make it difficult to follow the protocol
• History of calculus urinary
• Have a deterioration of underlying disease or a lung or upper respiratory tract infection within 30 days prior to baseline
• Initiation of pulmonary rehabilitation within 12 weeks prior to baseline
• At the time of consent, more than 1 year has passed since registration for lung transplantation, or surgery related to PH treatment is scheduled
• Have diseases or symptoms that limit evaluation of 6MWT (eg, peripheral vascular disease, musculoskeletal disorders, and obesity)

Sponsors & Collaborators

• NS Pharma, Inc.: lead
• Nippon Shinyaku Co., Ltd.: collaborator

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 30, 2026
• First Posted: February 27, 2026
• Study Start: July 1, 2026
• Primary Completion (Estimated): September 14, 2028
• Study Completion (Estimated): December 14, 2028
• Last Updated: February 27, 2026

Record last verified: 2026-01