Pulmonary Arterial Hypertension study: NS-863 Low Dose vs NS-863 High Dose
Official title Clinical Trial of NS-863 in Participants With Pulmonary Arterial Hypertension (PAH)
ClinicalTrials.gov ID: NCT07441200
What this study is testing
What is NS-863 Low Dose?
NS-863 Low Dose is an investigational medicine, taken by mouth, being studied as a potential treatment for pulmonary arterial hypertension.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- A Phase 2, Dose Finding Trial to look at how well it works and how safe it is of Orally Administered NS-863 in people with Pulmonary Arterial Hypertension (PAH)
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- Ability to provide written informed consent prior to participation in the trial, which includes the ability to comply with the requirements and...
- Adult male or female participants 18 (19 years in South Korea) to 75 years of age at the time the ICF is signed
- Idiopathic PAH (IPAH)
- Heritable PAH (HPAH)
- PAH associated drug and toxins (DPAH)
You likely can't join if
- 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
- Body mass index (BMI) ≥30 kg/m2 at the Screening Visit
See the full eligibility criteria
- 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).
- Adult male or female participants 18 (19 years in South Korea) to 75 years of age at the time the ICF is signed
- Idiopathic PAH (IPAH)
- Heritable PAH (HPAH)
- PAH associated drug and toxins (DPAH)
- 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
- Participants receiving treatment with endothelin receptor antagonists, phosphodiesterase type 5 inhibitors, soluble guanylate cyclase stimulators, prostacyclin analogs or prostacyclin receptor agonists, calcium channel...
- 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.
- 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...
- Able to complete the scheduled visits and follow the instructions of the investigator
- 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
- 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...
- 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...
The study team makes the final eligibility decision.
Where it is enrolling
- Kitakyushu, Japan
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Kitakyushu, Japan. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.