[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100621031":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":24,"centralContacts":28,"locations":34,"responsibleParty":59,"collaborators":24,"id":61,"slug":62,"hasResults":63,"nctId":64,"briefTitle":65,"officialTitle":66,"acronym":67,"eligibilityCriteria":68,"healthyVolunteers":63,"sex":69,"minAge":70,"maxAge":71,"enrollmentInfo":72,"targetDuration":24,"studyType":75,"phases":76,"briefSummary":78,"conditions":79,"keywords":24,"overallStatus":37,"whyStopped":24,"lastUpdateSubmitDate":81,"lastUpdatePostDateStruct":82,"startDateStruct":85,"completionDateStruct":87,"leadSponsor":89,"locationsCount":90},{"fullName":5,"class":6},"Inhibikase Therapeutics","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"IKT-001","EXPERIMENTAL","IKT-001 tablets for PO administration",[13],"Drug: IKT-001",{"label":15,"type":16,"description":17,"interventionNames":18},"Placebo","PLACEBO_COMPARATOR","Matching placebo to IKT-001 tablets for PO administration",[19],"Drug: Placebo",[21,25],{"type":22,"name":9,"description":11,"armGroupLabels":23,"otherNames":24},"DRUG",[9],null,{"type":22,"name":15,"description":26,"armGroupLabels":27,"otherNames":24},"Placebo to IKT-001 tablets for PO administration",[15],[29],{"name":30,"role":31,"phone":32,"phoneExt":24,"email":33},"Medical Director, Inhibikase Therapeutics","CONTACT","1-302-295-3800","info@inhibikase.com",[35,49],{"facility":36,"status":37,"city":38,"state":39,"zip":40,"country":41,"countryCode":42,"cosmosGeoPoint":43,"geoPoint":48,"contacts":24},"Norton Healthcare","RECRUITING","Louisville","Kentucky","40202","United States","US",{"type":44,"coordinates":45},"Point",[46,47],-85.75941,38.25424,{"lat":47,"lon":46},{"facility":50,"status":37,"city":51,"state":52,"zip":53,"country":41,"countryCode":42,"cosmosGeoPoint":54,"geoPoint":58,"contacts":24},"Tufts Medical Center","Boston","Massachusetts","02111",{"type":44,"coordinates":55},[56,57],-71.05977,42.35843,{"lat":57,"lon":56},{"type":60,"investigatorFullName":24,"investigatorTitle":24,"investigatorAffiliation":24,"oldNameTitle":24,"oldOrganization":24},"SPONSOR","100621031","phase-3-an-adaptive-program-of-ikt-001-in-pulmonary-arterial-hypertension-pah-100621031",false,"NCT07365332","An Adaptive Program of IKT-001 in Pulmonary Arterial Hypertension (PAH)","An Adaptive, 2-Part, Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate the Efficacy and Safety of IKT-001 in Pulmonary Arterial Hypertension (PAH)","IMPROVE-PAH","Inclusion Criteria:\n\n* Documented diagnosis of WHO PAH Group 1 in any of the following subtypes:\n\n  * Idiopathic PAH\n  * Heritable PAH\n  * Drug\u002Ftoxin-induced PAH\n  * PAH associated with connective tissue disease (CTD)\n  * PAH associated with simple, congenital systemic-to-pulmonary shunts at least 1 year following repair\n* Men and women 18 and 75 years of age (inclusive)\n* Must have a body mass index (BMI) of ≥18.5 kg\u002Fm\\^2 and ≤35.0 kg\u002Fm\\^2 at screening.\n* Baseline RHC performed during the Screening Period documenting a PVR of ≥ 400 dyn\u002Fsec\u002Fcm\\^5 ; pulmonary capillary wedge pressure (PCWP) ≤15 mmHg and mean pulmonary artery pressure (mPAP) \\>20 mmHg. PVR enrichment criteria to ensure population baseline PVR \\>700 dynes\u002Fsec\u002Fcm\\^5\n* On stable doses of background PAH therapy including endothelin receptor antagonists, phosphodiesterase-5 inhibitors, prostacyclins, and soluble guanylate cyclase stimulators for ≥90 days prior to screening. Current use of sotatercept is not permitted.\n* 6MWD ≥ 100 and ≤ 475 m\n\nExclusion Criteria:\n\n* Diagnosis of PAH WHO Groups 2, 3, 4, or 5.\n* Diagnosis of the following PAH Group 1 subtypes: human immunodeficiency virus (HIV)-associated PAH, PAH associated with portal hypertension, schistosomiasis-associated PAH, and pulmonary veno-occlusive disease.\n* Any of the following blood pressure-related values or abnormalities: Uncontrolled systemic hypertension as evidenced by sitting systolic BP \\>160 mmHg or sitting diastolic BP \\>100 mmHg at screening, Baseline systolic BP \\\u003C90 mmHg at screening, Syncope within 3 months prior to screening\n* History of restrictive, constrictive, or congestive cardiomyopathy.\n* ECG with Fridericia's corrected QT interval (QTcF) ≥ 450 msec in males or ≥ 470 msec in females at screening or ≥500 msec in the presence of a right bundle branch block.\n* Personal or family history of long QT syndrome or sudden cardiac death.\n* Presence of a CardioMEMS device or any other implanted hemodynamic monitoring device.\n* Forced vital capacity (FVC) \\\u003C70 percent on pulmonary function test (PFT) performed no more than 6 months prior to screening; or if FVC is 60 percent to 69 percent, must have a chest computed tomography scan within 12 months with no more than mild interstitial lung disease.\n* History of atrial fibrillation or atrial flutter.\n* History of cerebrovascular accident, intracranial hemorrhage, or subdural hematoma at anytime, or a fall associated with head trauma within 3 months of screening.\n* Acutely decompensated right heart failure within 30 days prior to screening, as per investigator assessment.\n* Clinically significant ischemic, valvular, constrictive heart disease, or heart failure with preserved ejection fraction in the opinion of the investigator.\n* History of pneumonectomy.\n* Untreated or inadequately treated (in the opinion of the investigator) obstructive sleep apnea.\n* Acute or chronic hepatitis B or C infection, defined as:\n\n  * Hepatitis B virus: a positive hepatitis B surface antigen test or a positive hepatitis B core antibody test with detectable DNA\n  * Hepatitis C virus (HCV): a positive hepatitis C antibody test with detectable HCV ribonucleic acid (RNA).Participants with a positive hepatitis C antibody test, but no detectable HCV RNA who completed treatment with direct-acting antivirals may be considered after discussion with the medical monitor.\n* History of or currently diagnosed with a bleeding disorder, including but not limited to hemophilia, von Willebrand disease, thrombocytopenia, or significant bleeding history defined as any bleeding event requiring medical intervention.\n* Received treatment with any of the following excluded medications:\n\n  * Currently receiving strong cytochrome P450 (CYP) 3A inducers or CYP3A inhibitors (except for topical administration)\n  * Currently receiving or anticipated need to receive any anticoagulant (e.g., heparins, vitamin K antagonists, direct oral anticoagulants, or direct thrombin inhibitors).\n  * Current use of sotatercept. Note: participants who previously received sotatercept may be considered if the last dose administered was \\>6 months prior to screening, participant had no significant bleeding events while on sotatercept.\n* Initiation of an exercise program for cardiopulmonary rehabilitation within 90 days prior to screening or planned initiation during the study (participants who are stable in the maintenance phase of a program and who will continue for the duration of the study are eligible).\n* History of atrial septostomy within 180 days prior to screening.\n* Current participation in another investigational clinical trial and\u002For receipt of any investigational medication within 90 days prior to screening.\n* Previous randomization into this or another IKT-001 study.\n* Any social, behavioral, or medical reason that would preclude completion of the study, in the judgement of the investigator.\n* Currently lactating, pregnant or planning on becoming pregnant during the study.\n* Prior receipt of a solid organ transplant or stem cell transplant.\n* Planned surgery that would require any study drug interruption or interfere with study assessments during the study (minor procedures may be allowed in consultation with the medical monitor).\n* Malignancy within the last 5 years prior to consent except completely treated non-metastatic-basal cell, squamous cell, in situ cervical cancer, and clinically localized National Comprehensive Cancer Network very low to low risk prostate cancer under active surveillance.","ALL","18 Years","75 Years",{"count":73,"type":74},486,"ESTIMATED","INTERVENTIONAL",[77],"PHASE3","This is an adaptive, 2-part, randomized, multicenter, double-blind, placebo-controlled, parallel-group study designed to evaluate the efficacy and safety of IKT-001 in adult participants with WHO Group 1 PAH.",[80],"Pulmonary Arterial Hypertension","2026-05-11",{"date":83,"type":84},"2026-05-12","ACTUAL",{"date":86,"type":84},"2026-04-23",{"date":88,"type":74},"2029-12",{"name":5,"class":6},2]