Clinical Trials List
Protocol NumberNS863B-P2-01
NCT Number(ClinicalTrials.gov Identfier)NCT07441278
Not yet recruiting
2026-07-01 - 2029-12-31
Phase II
Not yet recruiting1
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)
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Sponsor
PPD DEVELOPMENT (HK) LIMITED TAIWAN BRANCH
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Trial scale
Multi-Regional Multi-Center
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Update
2026/09/15
Investigators and Locations
Co-Principal Investigator
- YEN-HUNG LIN Division of Cardiovascular Diseases
- YAO-WEN KUO Division of Thoracic Medicine
- 侯鈞賀 Division of Ophthalmology
Co-Principal Investigator
- Kang-Ling Wang 臨床試驗科
- 張皓智 Division of Cardiovascular Diseases
- Jia-Yih Feng Division of Thoracic Medicine
- 蕭逸函 Division of Thoracic Medicine
- Wei-Zhi Chen Division of Thoracic Medicine
- 游偉光 Division of Ophthalmology
Co-Principal Investigator
- 鄭孟軒 Division of Thoracic Medicine
- Ming-Ju Tsai Division of Thoracic Medicine
- Wei-An Chang Division of Thoracic Medicine
- Hung-Ling Huang Division of Thoracic Medicine
- 鄭至宏 Division of Thoracic Medicine
- jong rung Tsai Division of Thoracic Medicine
- 李岱晃 Division of Thoracic Medicine
- 莊政皓 Division of Thoracic Medicine
- Chun-Yuan Chu Division of Cardiovascular Diseases
- 黃天祈 Division of Cardiovascular Diseases
- 吳韋璁 Division of Cardiovascular Diseases
- Po-Chao Hsu Division of Cardiovascular Diseases
Co-Principal Investigator
- 吳書豪 Division of Cardiovascular Diseases
Co-Principal Investigator
- 王振宇 Division of Thoracic Medicine
- 黃丞正 Division of Thoracic Medicine
- 蕭亦均 Division of Thoracic Medicine
- 陳昱瑋 Division of Cardiovascular Diseases
- WEI-WEN LIN Division of Cardiovascular Diseases
Principal Investigator
Wan-Jing Ho
The Actual Total Number of Participants Enrolled
0 Not yet recruiting
Condition/Disease
Pulmonary Hypertension Associated With Interstitial Lung Disease (PH-ILD)
Objectives
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)
Test Drug
NS-863
Active Ingredient
NS-863
Dosage Form
Tablet
Dosage
58 mg
Endpoints
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
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
Inclution Criteria
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
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
Exclusion Criteria
Participants meeting any of the following criteria at the Screening Visit or baseline are ineligible to participate in this trial:
Have a diagnosis of PAH or PH for reasons other than WHO Group 3 PH-ILD as outlined in inclusion criterion 3
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)
Participants who have participated in another clinical trial involving a drug or medical device, or have received treatment with an investigational product (including investigational formulations of marketed products), within 30 days prior to the Screening Visit or within 5 terminal phase half-lives of the investigational product, whichever is longer
Life expectancy is less than 6 months
Acute pulmonary embolism within 90 days prior to baseline
Current cigarette or e-cigarette smokers or those who have quit within the past 6 months, with a history of ≥20 pack-years smoking
Participants who are pregnant, breastfeeding, or planning to become pregnant during the time of trial participation
Use of dual platelet inhibitor therapy
Severe acute or chronic medical or laboratory abnormality that may increase the risk associated with trial participation or trial treatment administration
Have a history of allergies to the excipients in the trial treatment
Known human immunodeficiency virus (HIV) positive status
Active hepatitis due to hepatitis B virus or hepatitis C virus
Use of any protocol prohibited medications.
Receipt of any live vaccine within 4 weeks prior to the first dose of trial treatment or expected need for live vaccination during trial participation, including at least 4 weeks after the last dose of trial treatment
The investigator has judged the participant as unwilling or unable to
comply with the protocol
Other concurrent disease and/or medical condition that, in the judgment of the investigator, may put the participant at risk or may influence the results of the trial or the participant's ability to complete the entire duration of the trial
Have a diagnosis of PAH or PH for reasons other than WHO Group 3 PH-ILD as outlined in inclusion criterion 3
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)
Participants who have participated in another clinical trial involving a drug or medical device, or have received treatment with an investigational product (including investigational formulations of marketed products), within 30 days prior to the Screening Visit or within 5 terminal phase half-lives of the investigational product, whichever is longer
Life expectancy is less than 6 months
Acute pulmonary embolism within 90 days prior to baseline
Current cigarette or e-cigarette smokers or those who have quit within the past 6 months, with a history of ≥20 pack-years smoking
Participants who are pregnant, breastfeeding, or planning to become pregnant during the time of trial participation
Use of dual platelet inhibitor therapy
Severe acute or chronic medical or laboratory abnormality that may increase the risk associated with trial participation or trial treatment administration
Have a history of allergies to the excipients in the trial treatment
Known human immunodeficiency virus (HIV) positive status
Active hepatitis due to hepatitis B virus or hepatitis C virus
Use of any protocol prohibited medications.
Receipt of any live vaccine within 4 weeks prior to the first dose of trial treatment or expected need for live vaccination during trial participation, including at least 4 weeks after the last dose of trial treatment
The investigator has judged the participant as unwilling or unable to
comply with the protocol
Other concurrent disease and/or medical condition that, in the judgment of the investigator, may put the participant at risk or may influence the results of the trial or the participant's ability to complete the entire duration of the trial
The Estimated Number of Participants
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Taiwan
22 participants
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Global
177 participants
