[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"NS Pharma, Inc.\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":91},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,46,71],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":30,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":40,"leadSponsor":42,"locationsCount":45},"100515784","phase-2-ns-089ncnp-02-201-in-boys-with-duchenne-muscular-dystrophy-dmd-100515784",false,"NCT05996003","NS-089\u002FNCNP-02-201 in Boys With Duchenne Muscular Dystrophy (DMD)","A Phase 2 Study to Assess the Efficacy, Safety, Tolerability, and Pharmacokinetics of NS-089\u002FNCNP-02 in Boys With Duchenne Muscular Dystrophy (DMD)","Inclusion Criteria:\n\n* Male ≥ 4 years and \\\u003C15 years of age\n* Confirmed DMD mutation(s) in the dystrophin gene that is amenable to skipping of exon 44 to restore the dystrophin mRNA reading frame\n* Able to walk independently without assistive devices\n* Ability to complete the TTSTAND without assistance in \\\u003C20 seconds\n* Stable dose of glucocorticoid for at least 3 months and the dose is expected to remain on a stable dose for the duration of the study.\n* Other inclusion criteria may apply.\n\nExclusion Criteria:\n\n* Has a body weight of \\\u003C20 kg at the time of informed consent (applies to participants screening for Part 1 only)\n* Evidence of symptomatic cardiomyopathy\n* Current or previous treatment with anabolic steroids (e.g., oxandrolone) or products containing resveratrol or adenosine triphosphate within 3 months prior to first dose of study drug\n* Current or previous treatment with any other investigational drug within 3 months prior to the first dose of study drug or within 5 times the half-life of a medication, whichever is longer\n* Surgery within the 3 months prior to the first dose of study drug or planned during the study duration\n* Previously treated in an interventional study of NS-089\u002FNCNP-02\n* Having received exon skipping oligonucleotide within 1 year prior to the first dose of IP\n* Other exclusion criteria may apply.","MALE","4 Years","14 Years",{"count":20,"type":21},20,"ESTIMATED","INTERVENTIONAL",[24],"PHASE2","This is a Phase 2, open-label, multi-center, 2-part study of NS-089\u002FNCNP-02 administered by weekly IV infusion to ambulant boys aged ≥4 to \\\u003C15 years with DMD due to mutations amenable to exon 44 skipping. Participants will receive a selected dose of NS-089\u002FNCNP-02 administered once weekly.\n\nThe study consists of 2 parts: Part 1 and Part 2. Six participants (Cohort 1) will participate in both Part 1 and Part 2, and 14 participants (Cohort 2) will be added for Part 2.",[27,28,29],"Duchenne Muscular Dystrophy","Exon 44","DMD",[31,29,32],"Exon 44 Skipping","Brogidirsen","RECRUITING","2026-03-04",{"date":36,"type":37},"2026-03-06","ACTUAL",{"date":39,"type":37},"2024-02-22",{"date":41,"type":21},"2026-09-11",{"name":43,"class":44},"NS Pharma, Inc.","INDUSTRY",25,{"id":47,"slug":48,"hasResults":11,"nctId":49,"briefTitle":50,"officialTitle":51,"acronym":4,"eligibilityCriteria":52,"healthyVolunteers":11,"sex":53,"minAge":54,"maxAge":55,"enrollmentInfo":56,"targetDuration":4,"studyType":22,"phases":58,"briefSummary":59,"conditions":60,"keywords":4,"overallStatus":62,"whyStopped":4,"lastUpdateSubmitDate":63,"lastUpdatePostDateStruct":64,"startDateStruct":66,"completionDateStruct":68,"leadSponsor":70,"locationsCount":4},"100626872","phase-2-a-clinical-trial-of-ns-863-in-participants-with-pulmonary-hypertension-associated-with-interstitial-lung-disease-ph-ild-100626872","NCT07441278","A Clinical Trial of NS-863 in Participants With Pulmonary Hypertension Associated With Interstitial Lung Disease (PH-ILD)","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)","Inclusion Criteria:\n\nParticipants must meet all of the following criteria to be included in the trial:\n\n* 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\n* Adult male or female participants 18 to 80 years of age at the time the ICF is signed\n* 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:\n\n  1. ILD\n  2. 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\n* Results of the RHC within 35 days prior to Day 1 and meet all of the following criteria:\n\n  1. Participants receiving treatment with endothelin receptor antagonists, phosphodiesterase type 5 inhibitors, soluble guanylate cyclase stimulators, prostacyclin analogs or prostacyclin receptor agonists, and\u002For 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.\n  2. 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\n  3. 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\n* Valid 6MWD\n* 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\n* Able to complete the scheduled visits and follow the instructions of the investigator\n\nExclusion Criteria:\n\nParticipants meeting any of the following criteria at the Screening Visit or baseline are ineligible to participate in this trial:\n\n* Have a diagnosis of PAH or PH for reasons other than WHO Group 3 PH-ILD as outlined in inclusion criterion 3\n* Have evidence of clinically significant left-sided heart disease, as defined by:\n\n  a. LVEF \\\u003C40% Notes: Participants with abnormal LV function attributable entirely to impaired LV filling due to the effects of RV overload (ie, RV hypertrophy and\u002For dilatation) will not be excluded\n* Receiving \\> 6 L\u002Fmin of oxygen supplementation by any mode of delivery at rest at baseline\n* Moderate or severe liver, renal, blood, or psychiatric disease:\n\n  1. Moderate and severe hepatic impairment by the Child-Pugh scoring system (Class B and Class C)\n  2. Moderate and severe renal impairment by estimated glomerular filtration rate (eGFR) \\\u003C60 mL\u002Fmin\u002Fm2\n  3. Have mental disorders or other conditions that make it difficult to follow the protocol\n* History of clinically significant (per investigator's judgment) drug or alcohol abuse disorder within the last 6 months\n* Have mental disorders or other conditions that make it difficult to follow the protocol\n* History of calculus urinary\n* Have a deterioration of underlying disease or a lung or upper respiratory tract infection within 30 days prior to baseline\n* Initiation of pulmonary rehabilitation within 12 weeks prior to baseline\n* At the time of consent, more than 1 year has passed since registration for lung transplantation, or surgery related to PH treatment is scheduled\n* Have diseases or symptoms that limit evaluation of 6MWT (eg, peripheral vascular disease, musculoskeletal disorders, and obesity)\n* 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\n* Life expectancy is less than 6 months\n* Acute pulmonary embolism within 90 days prior to baseline\n* Current cigarette or e-cigarette smokers or those who have quit within the past 6 months, with a history of ≥20 pack-years smoking\n* Participants who are pregnant, breastfeeding, or planning to become pregnant during the time of trial participation\n* Use of dual platelet inhibitor therapy\n* Severe acute or chronic medical or laboratory abnormality that may increase the risk associated with trial participation or trial treatment administration\n* Have a history of allergies to the excipients in the trial treatment\n* Known human immunodeficiency virus (HIV) positive status\n* Active hepatitis due to hepatitis B virus or hepatitis C virus\n* Use of any protocol prohibited medications.\n* 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\n* The investigator has judged the participant as unwilling or unable to\n* comply with the protocol\n* Other concurrent disease and\u002For 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","ALL","18 Years","80 Years",{"count":57,"type":21},177,[24],"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)",[61],"Pulmonary Hypertension Associated With Interstitial Lung Disease (PH-ILD)","NOT_YET_RECRUITING","2026-02-24",{"date":65,"type":37},"2026-02-27",{"date":67,"type":21},"2026-07-01",{"date":69,"type":21},"2028-12-14",{"name":43,"class":44},{"id":72,"slug":73,"hasResults":11,"nctId":74,"briefTitle":75,"officialTitle":76,"acronym":4,"eligibilityCriteria":77,"healthyVolunteers":11,"sex":53,"minAge":54,"maxAge":78,"enrollmentInfo":79,"targetDuration":4,"studyType":22,"phases":81,"briefSummary":82,"conditions":83,"keywords":85,"overallStatus":62,"whyStopped":4,"lastUpdateSubmitDate":63,"lastUpdatePostDateStruct":86,"startDateStruct":87,"completionDateStruct":88,"leadSponsor":90,"locationsCount":4},"100626866","phase-2-clinical-trial-of-ns-863-in-participants-with-pulmonary-arterial-hypertension-pah-100626866","NCT07441200","Clinical Trial of 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)","Inclusion Criteria:\n\n* 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\n* Adult male or female participants 18 to 75 years of age at the time the ICF is signed\n* 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:\n\n  1. Idiopathic PAH (IPAH)\n  2. Heritable PAH (HPAH)\n  3. PAH associated drug and toxins (DPAH)\n  4. PAH associated with connective tissue disease (PAH-CTD)\n  5. PAH associated with congenital heart disease (PAH-CHD); simple systemic to pulmonary shunt at least 6 months after surgical repair\n* Diagnosed as WHO FC II, III, or IV on stable background therapy\n* Results of the RHC within 35 days prior to Day 1 and meet all of the following criteria:\n\n  1. 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\u002For 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\n  2. 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.\n* Valid 6-minute walk distance (6MWD)\n* 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\n* Able to complete the scheduled visits and follow the instructions of the investigator\n\nExclusion Criteria:\n\n* Current diagnosis of the following PAH Group 1 subtypes:\n\n  1. PAH associated with human immunodeficiency virus (HIV) infection\n  2. PAH associated with portal hypertension\n  3. PAH associated with schistosomiasis\n  4. PAH with features of venous\u002Fcapillary involvement\n  5. Eisenmenger syndrome and PAH associated with prevalent systemic to pulmonary shunts in PAH-CHD\n* Have ≥3 of the following LV disease\u002Fdysfunction risk factors. :\n\n  1. Body mass index (BMI) ≥30 kg\u002Fm2 at the Screening Visit\n  2. History of essential hypertension\n  3. Diabetes mellitus (any type)\n  4. Historical evidence of significant coronary artery disease\n* Diagnosis of PH Groups 2, 3, 4, or 5 of the classification\n* Moderate or severe obstructive lung disease (forced expiratory volume in one second \\[FEV1\\]\u002Fforced vital capacity \\[FVC\\] \\\u003C0.6) or restrictive lung disease (total lung capacity \\[TLC\\] \\\u003C70% of predicted value or lung diffusion capacity for carbon monoxide \\[DLco\\] \\\u003C45% except for PAH-systemic sclerosis) during the Screening Period.\n* Moderate or severe liver, renal, blood, or psychiatric disease:\n\n  1. Moderate and severe hepatic impairment by the Child-Pugh scoring system (Class B and Class C)\n  2. Moderate and severe renal impairment by estimated glomerular filtration rate (eGFR) \\\u003C60 mL\u002Fmin\u002Fm2\n  3. Have mental disorders or other conditions that make it difficult to follow the protocol\n* History of clinically significant (per investigator's judgment) drug or alcohol abuse disorder\n* History of calculus urinary\n* Initiation of pulmonary rehabilitation within 12 weeks prior to baseline\n* Have diseases or symptoms that limit evaluation of 6MWT\n* Life expectancy is less than 1 year\n* Participants who are pregnant, breastfeeding, or planning to become pregnant during the time of trial participation\n* Severe acute or chronic medical or laboratory abnormality that may increase the risk associated with trial participation or trial treatment administration\n* Have a history of allergies to the excipients in the trial treatment\n* Known HIV positive status\n* Active hepatitis due to hepatitis B virus or hepatitis C virus\n* Use of any protocol prohibited medications\n* 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\n* The investigator has judged the participant as unwilling or unable to comply with the protocol\n* Other concurrent disease and\u002For 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.","75 Years",{"count":80,"type":21},135,[24],"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)",[84],"Pulmonary Arterial Hypertension",[84],{"date":65,"type":37},{"date":67,"type":21},{"date":89,"type":21},"2028-11-01",{"name":43,"class":44},""]