Pulmonary Arterial HypertensionPhase 2NCT07441200
Clinical Trial of NS-863 in Participants With Pulmonary Arterial Hypertension (PAH)
A Phase 2 study testing NS-863 Low Dose and NS-863 High Dose in people with Pulmonary Arterial Hypertension, run by NS Pharma, Inc. at 1 site in Japan.
Trial 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 Arterial Hypertension (PAH) Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Pulmonary Arterial Hypertension
- What is being tested?
- NS-863 Low Dose and NS-863 High Dose
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 135 participants
- Where
- 1 siteJapan
- Study dates
- 29 Sep 2026to 1 Nov 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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 (19 years in South Korea) to 75 years of age at the time the ICF is signed
- Diagnosed with Group 1 PAH and pre-capillary PH defined by RHC during or at any time prior to the Screening Visit in any of the following subtypes:
- Idiopathic PAH (IPAH)
- Heritable PAH (HPAH)
- PAH associated drug and toxins (DPAH)
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- PAH associated with connective tissue disease (PAH-CTD)
- PAH associated with congenital heart disease (PAH-CHD); simple systemic to pulmonary shunt at least 6 months after surgical repair
- Diagnosed as WHO FC II, III, or IV on stable background therapy
- 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, calcium channel blocker, and/or diuretics 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. Stable diuretic therapy is defined as no addition of a new diuretic and no switching of a preexistent oral diuretic to parenteral administration; however, dose adjustments (up or down) in preexistent oral diuretics are acceptable
- Participants receiving treatment with activin-signaling inhibitor are eligible only if on a stable dose for at least 180 days prior to RHC at baseline and throughout the Screening Period. Dose adjustment based on the participant's body weight is allowed per medical practice.
- Valid 6-minute walk distance (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
Who cannot join
- Current diagnosis of the following PAH Group 1 subtypes:
- PAH associated with human immunodeficiency virus (HIV) infection
- PAH associated with portal hypertension
- PAH associated with schistosomiasis
- PAH with features of venous/capillary involvement
- Eisenmenger syndrome and PAH associated with prevalent systemic to pulmonary shunts in PAH-CHD
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- Have ≥3 of the following LV disease/dysfunction risk factors. :
- Body mass index (BMI) ≥30 kg/m2 at the Screening Visit
- History of essential hypertension
- Diabetes mellitus (any type)
- Historical evidence of significant coronary artery disease
- Diagnosis of PH Groups 2, 3, 4, or 5 of the classification
- Moderate or severe obstructive lung disease (forced expiratory volume in one second [FEV1]/forced vital capacity [FVC] <0.6) or restrictive lung disease (total lung capacity [TLC] <70% of predicted value or lung diffusion capacity for carbon monoxide [DLco] <45% except for PAH-systemic sclerosis) during the Screening Period.
- 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/1.73 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
- History of calculus urinary
- History of acute kidney injury within 12 weeks prior to the start of the Screening Visit
- Participants who have hematuria (>5 RBC/hpf) or proteinuria (urine albumin creatinine ratio [UACR] >150 mg/g or urine protein creatinine ratio [UPCR] >400 mg/g) at the Screening Visit
- Initiation of pulmonary or cardiac rehabilitation within 12 weeks prior to baseline
- Have diseases or symptoms that limit evaluation of 6MWT
- Life expectancy is less than 1 year
- Participants who are pregnant, breastfeeding, or planning to become pregnant during the time of trial participation
- 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 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Japan1 site, 1 recruiting
- Recruiting
Hospital of the University of Occupational and Environmental Health
Kitakyushu, 807-8556
About this study
Official title: 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 Arterial Hypertension (PAH)
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 Arterial Hypertension (PAH)
- Conditions
- Pulmonary Arterial Hypertension
- Being tested
- NS-863 Low Dose, NS-863 High Dose, NS-863 Placebo
- Keywords
- Pulmonary Arterial Hypertension
- Medical subject headings
- Pulmonary Arterial Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NS-863 Low DoseDrug
NS-863 is an orally administered drug
NS-863 High DoseDrug
NS-863 is an orally administered drug
NS-863 PlaceboDrug
An orally administered NS-863 matching placebo
| Study group | Role | What they receive |
|---|---|---|
| NS-863 Low Dose | Active comparator | NS-863 is an orally administered drug Receives: Drug: NS-863 Low Dose |
| NS-863 High Dose | Active comparator | NS-863 is an orally administered drug Receives: Drug: NS-863 High Dose |
| NS-863 Placebo | Placebo comparator | An orally administered NS-863 matching placebo Receives: Drug: NS-863 Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in pulmonary vascular resistance (PVR) at week 24
PVR is a hemodynamic variable of pulmonary circulation measured by right heart catheterization (RHC).
Measured: 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.
Measured: From baseline to week 24
Secondary outcomes (6)
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.
Measured: From baseline to week 24
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).
Measured: From baseline to weeks 12 and 24
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
Measured: From baseline to weeks 12 and 24
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
Measured: From baseline to weeks 12 and 24
Change in echocardiogram at weeks 12 and 24
An echocardiogram (echo) is a noninvasive, radiation-free ultrasound test that uses sound waves to produce moving images of the heart's structure, valves, and blood flow.
Measured: From baseline to weeks 12 and 24
Change in PAH-Symptoms and Impact (SYMPACT®) at weeks 12 and 24
The PAH-SYMPACT® is a self-rating questionnaire that measures the severity of PAH symptoms and their impact on daily life. The questionnaire consists of 16 symptoms and 25 impact items.
Measured: From baseline to weeks 12 and 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2026
- Study start29 Sep 2026
- Primary completion1 Aug 2028 (estimated)
- Study completion1 Nov 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary Arterial HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 135 participants (estimated)
Sponsor and investigators
- Lead sponsor
- NS Pharma, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Nippon Shinyaku Co., Ltd.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07441200
- Sponsor's protocol ID
- NS-863A-P2-01
- Status last verified
- Oct 2026
- First submitted
- 30 Jan 2026
- Last updated
- 28 Oct 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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 Arterial Hypertension (PAH)
- ClinicalTrials.gov ID
- NCT07441200
- Acronym / sponsor ID
- NS-863A-P2-01
- Conditions
- Pulmonary Arterial Hypertension
- Keywords
- Pulmonary Arterial Hypertension
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 135 participants (estimated)
- Lead sponsor
- NS Pharma, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Nippon Shinyaku Co., Ltd.
- Study start
- 29 Sep 2026 (actual)
- Primary completion
- 1 Aug 2028 (estimated)
- Study completion
- 1 Nov 2028 (estimated)
- First posted
- 27 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 Arterial Hypertension (PAH)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| NS-863 Low Dose | Active comparator | Drug: NS-863 Low DoseNS-863 is an orally administered drug |
| NS-863 High Dose | Active comparator | Drug: NS-863 High DoseNS-863 is an orally administered drug |
| NS-863 Placebo | Placebo comparator | Drug: NS-863 PlaceboAn orally administered NS-863 matching placebo |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- 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 (19 years in South Korea) to 75 years of age at the time the ICF is signed
- Diagnosed with Group 1 PAH and pre-capillary PH defined by RHC during or at any time prior to the Screening Visit in any of the following subtypes:
- Diagnosed as WHO FC II, III, or IV on stable background therapy
- Results of the RHC within 35 days prior to Day 1 and meet all of the following criteria:
Key exclusion criteria (33 listed)
- Current diagnosis of the following PAH Group 1 subtypes:
- Have ≥3 of the following LV disease/dysfunction risk factors. :
- Diagnosis of PH Groups 2, 3, 4, or 5 of the classification
- Moderate or severe obstructive lung disease (forced expiratory volume in one second [FEV1]/forced vital capacity [FVC] <0.6) or restrictive lung disease (total lung capacity [TLC] <70% of predicted value or lung diffusion capacity for carbon monoxide [DLco] <45% except for PAH-systemic sclerosis) during the Screening Period.
- Moderate or severe liver, renal, blood, or psychiatric disease:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NS-863 Low DoseNS-863 is an orally administered drug | Drug | NS-863 Low Dose |
| NS-863 High DoseNS-863 is an orally administered drug | Drug | NS-863 High Dose |
| NS-863 PlaceboAn orally administered NS-863 matching placebo | Drug | NS-863 Placebo |
Primary outcome
Change in pulmonary vascular resistance (PVR) at week 24
Time frame: From baseline to week 24
PVR is a hemodynamic variable of pulmonary circulation measured by right heart catheterization (RHC).
Number of participants who experienced an adverse event (AE) up to approximately 24 weeks.
Time frame: From baseline to week 24
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.
6 secondary outcomes
Change in hemodynamic parameters at Week 24
Time frame: From baseline to week 24
Change in 6-minute walk distance (6MWD) at weeks 12 and 24
Time frame: From baseline to weeks 12 and 24
Change in Borg dyspnea scale at Week 12 and 24
Time frame: From baseline to weeks 12 and 24
Change in Word Health Organization Functional Classification (WHO FC) at weeks 12 and 24
Time frame: From baseline to weeks 12 and 24
Change in echocardiogram at weeks 12 and 24
Time frame: From baseline to weeks 12 and 24
Change in PAH-Symptoms and Impact (SYMPACT®) at weeks 12 and 24
Time frame: From baseline to weeks 12 and 24
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing NS-863 Low Dose and NS-863 High Dose in people with Pulmonary Arterial Hypertension, run by NS Pharma, Inc. at 1 site in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 33 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 28 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Trial info (1-866-677-4276, trialinfo@nspharma.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in pulmonary vascular resistance (PVR) at week 24 (time frame: From baseline to week 24). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Oct 2026.