[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07365332":3,"trial-entities:NCT07365332":451,"trial-summary:NCT07365332":454},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":20,"study_type":21,"primary_purpose":22,"phases":23,"enrollment_info":25,"interventions":28,"primary_outcomes":38,"secondary_outcomes":46,"sex":54,"minimum_age":55,"maximum_age":56,"healthy_volunteers":57,"eligibility_criteria":58,"std_ages":104,"locations":107,"central_contacts":442,"overall_officials":448,"references":449,"see_also_links":450},"NCT07365332","IKT-001-201","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)","RECRUITING","2029-12","2026-05","2026-09-02","2026-04-23","Inhibikase Therapeutics","INDUSTRY",true,"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.",null,[19],"Pulmonary Arterial Hypertension",[],"INTERVENTIONAL","TREATMENT",[24],"PHASE3",{"count":26,"type":27},486,"ESTIMATED",[29,34],{"type":30,"name":31,"description":32,"armGroupLabels":33},"DRUG","IKT-001","IKT-001 tablets for PO administration",[31],{"type":30,"name":35,"description":36,"armGroupLabels":37},"Placebo","Placebo to IKT-001 tablets for PO administration",[35],[39,43],{"measure":40,"description":41,"timeFrame":42},"[Part A] To evaluate the effect on Pulmonary Vascular Resistance (PVR) in participants with WHO Group 1 PAH treated with IKT-001 compared to placebo","Change in Pulmonary Vascular Resistance (PVR)","Baseline to Week 24",{"measure":44,"description":45,"timeFrame":42},"[Part B] To characterize the effects of IKT-001 on symptoms and characteristics of Pulmonary Arterial Hypertension compared to placebo","Change in 6-minute walk distance (6MWD)",[47,51],{"measure":48,"description":49,"timeFrame":50},"To characterize the effects of IKT-001 on WHO Functional Class","Change in WHO Functional Class","Baseline up to Week 48",{"measure":52,"description":53,"timeFrame":50},"To characterize the effects of IKT-001 on time to clinical worsening","Time to clinical worsening","ALL","18 Years","75 Years",false,{"inclusion":59,"exclusion":71,"raw_text":103},[60,61,62,63,64,65,66,67,68,69,70],"Documented diagnosis of WHO PAH Group 1 in any of the following subtypes:","Idiopathic PAH","Heritable PAH","Drug\u002Ftoxin-induced PAH","PAH associated with connective tissue disease (CTD)","PAH associated with simple, congenital systemic-to-pulmonary shunts at least 1 year following repair","Men and women 18 and 75 years of age (inclusive)","Must have a body mass index (BMI) of ≥18.5 kg\u002Fm\\^2 and ≤35.0 kg\u002Fm\\^2 at screening.","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","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.","6MWD ≥ 100 and ≤ 475 m",[72,73,74,75,76,77,78,79,80,81,82,83,84,85,86,87,88,89,90,91,92,93,94,95,96,97,98,99,100,101,102],"Diagnosis of PAH WHO Groups 2, 3, 4, or 5.","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.","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","History of restrictive, constrictive, or congestive cardiomyopathy.","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.","Personal or family history of long QT syndrome or sudden cardiac death.","Presence of a CardioMEMS device or any other implanted hemodynamic monitoring device.","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.","History of atrial fibrillation or atrial flutter.","History of cerebrovascular accident, intracranial hemorrhage, or subdural hematoma at anytime, or a fall associated with head trauma within 3 months of screening.","Acutely decompensated right heart failure within 30 days prior to screening, as per investigator assessment.","Clinically significant ischemic, valvular, constrictive heart disease, or heart failure with preserved ejection fraction in the opinion of the investigator.","History of pneumonectomy.","Untreated or inadequately treated (in the opinion of the investigator) obstructive sleep apnea.","Acute or chronic hepatitis B or C infection, defined as:","Hepatitis B virus: a positive hepatitis B surface antigen test or a positive hepatitis B core antibody test with detectable DNA","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.","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.","Received treatment with any of the following excluded medications:","Currently receiving strong cytochrome P450 (CYP) 3A inducers or CYP3A inhibitors (except for topical administration)","Currently receiving or anticipated need to receive any anticoagulant (e.g., heparins, vitamin K antagonists, direct oral anticoagulants, or direct thrombin inhibitors).","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.","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).","History of atrial septostomy within 180 days prior to screening.","Current participation in another investigational clinical trial and\u002For receipt of any investigational medication within 90 days prior to screening.","Previous randomization into this or another IKT-001 study.","Any social, behavioral, or medical reason that would preclude completion of the study, in the judgement of the investigator.","Currently lactating, pregnant or planning on becoming pregnant during the study.","Prior receipt of a solid organ transplant or stem cell transplant.","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).","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.","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.",[105,106],"ADULT","OLDER_ADULT",[108,117,125,132,139,147,155,163,171,179,186,193,201,209,217,225,230,239,248,257,265,273,282,291,300,308,316,324,333,341,348,357,364,372,377,384,388,396,404,411,418,427,435],{"facility":109,"status":8,"city":110,"state":111,"zip":112,"country":113,"geoPoint":114},"Arizona Pulmonary Specialists, LTD","Scottsdale","Arizona","85258","United States",{"lat":115,"lon":116},33.50921,-111.89903,{"facility":118,"status":8,"city":119,"state":120,"zip":121,"country":113,"geoPoint":122},"Cedars Sinai","Beverly Hills","California","90211",{"lat":123,"lon":124},34.07362,-118.40036,{"facility":126,"status":8,"city":127,"state":120,"zip":128,"country":113,"geoPoint":129},"Jeffrey S. Sager, MD Medical Corporation","Santa Barbara","93105",{"lat":130,"lon":131},34.42083,-119.69819,{"facility":133,"status":8,"city":134,"state":120,"zip":135,"country":113,"geoPoint":136},"Lundquist at Harbor UCLA","Torrance","90502",{"lat":137,"lon":138},33.83585,-118.34063,{"facility":140,"status":8,"city":141,"state":142,"zip":143,"country":113,"geoPoint":144},"University of Colorado Anschutz Medical Campus","Aurora","Colorado","80045",{"lat":145,"lon":146},39.72943,-104.83192,{"facility":148,"status":8,"city":149,"state":150,"zip":151,"country":113,"geoPoint":152},"University of Kansas Medical Center","Kansas City","Kansas","66103",{"lat":153,"lon":154},39.11417,-94.62746,{"facility":156,"status":8,"city":157,"state":158,"zip":159,"country":113,"geoPoint":160},"Norton Healthcare","Louisville","Kentucky","40202",{"lat":161,"lon":162},38.25424,-85.75941,{"facility":164,"status":8,"city":165,"state":166,"zip":167,"country":113,"geoPoint":168},"Tufts Medical Center","Boston","Massachusetts","02111",{"lat":169,"lon":170},42.35843,-71.05977,{"facility":172,"status":8,"city":173,"state":174,"zip":175,"country":113,"geoPoint":176},"Washington University School of Medicine","St Louis","Missouri","63110",{"lat":177,"lon":178},38.62727,-90.19789,{"facility":180,"status":8,"city":181,"state":181,"zip":182,"country":113,"geoPoint":183},"NYU Langone Health","New York","10016",{"lat":184,"lon":185},40.71427,-74.00597,{"facility":187,"status":8,"city":188,"state":181,"zip":189,"country":113,"geoPoint":190},"Westchester Medical Center","Valhalla","10595",{"lat":191,"lon":192},41.07482,-73.77513,{"facility":194,"status":8,"city":195,"state":196,"zip":197,"country":113,"geoPoint":198},"Duke University","Durham","North Carolina","27710",{"lat":199,"lon":200},35.99403,-78.89862,{"facility":202,"status":8,"city":203,"state":204,"zip":205,"country":113,"geoPoint":206},"University of Cincinnati","Cincinnati","Ohio","45267",{"lat":207,"lon":208},39.12711,-84.51439,{"facility":210,"status":8,"city":211,"state":212,"zip":213,"country":113,"geoPoint":214},"Vanderbilt University Medical Center","Nashville","Tennessee","37232-7610",{"lat":215,"lon":216},36.16589,-86.78444,{"facility":218,"status":8,"city":219,"state":220,"zip":221,"country":113,"geoPoint":222},"UT Southwestern Medical Center","Dallas","Texas","75390",{"lat":223,"lon":224},32.78306,-96.80667,{"facility":226,"status":8,"city":227,"state":227,"zip":228,"country":229},"Sanatorio de la Trinidad Palermo","Buenos Aires","1425","Argentina",{"facility":231,"status":8,"city":232,"state":233,"zip":234,"country":235,"geoPoint":236},"Pulmonary Hypertension Research Queensland PHRQ","Auchenflower","Queensland","4066","Australia",{"lat":237,"lon":238},-27.47443,152.99213,{"facility":240,"status":8,"city":241,"state":242,"zip":243,"country":244,"geoPoint":245},"Hôpital Universitaire de Bruxelles - Erasme","Anderlecht","Brussels Capital","1070","Belgium",{"lat":246,"lon":247},50.83619,4.31454,{"facility":249,"status":8,"city":250,"state":251,"zip":252,"country":253,"geoPoint":254},"University of Alberta Hospital","Edmonton","Alberta","T6G 2B7","Canada",{"lat":255,"lon":256},53.55014,-113.46871,{"facility":258,"status":8,"city":259,"state":260,"zip":261,"country":260,"geoPoint":262},"Hôpital Bicêtre","Le Kremlin-Bicêtre","France","94270",{"lat":263,"lon":264},48.81471,2.36073,{"facility":266,"status":8,"city":267,"state":268,"zip":269,"country":260,"geoPoint":270},"CHRU Strasbourg","Strasbourg","Grand Est","67091",{"lat":271,"lon":272},48.58392,7.74553,{"facility":274,"status":8,"city":275,"state":276,"zip":277,"country":278,"geoPoint":279},"Medizinische Hochschule Hannover, Abteilung Pneumologie und Infektiologie","Hanover","Lower Saxony","30625","Germany",{"lat":280,"lon":281},52.37052,9.73322,{"facility":283,"status":8,"city":284,"state":285,"zip":286,"country":287,"geoPoint":288},"Fondazione IRCCS San Gerardo dei Tintori","Monza","Monza and Brianza","20900","Italy",{"lat":289,"lon":290},45.58005,9.27246,{"facility":292,"status":8,"city":293,"state":294,"zip":295,"country":296,"geoPoint":297},"Amsterdam UMC site VUMC","Amsterdam","North Holland","1081 BT","Netherlands",{"lat":298,"lon":299},52.37403,4.88969,{"facility":301,"status":8,"city":302,"state":302,"zip":303,"country":304,"geoPoint":305},"Auckland City Hospital","Auckland","1051","New Zealand",{"lat":306,"lon":307},-36.84853,174.76349,{"facility":309,"status":8,"city":310,"state":311,"zip":312,"country":304,"geoPoint":313},"University of Otago Christchurch","Christchurch","Canterbury","8011",{"lat":314,"lon":315},-43.53333,172.63333,{"facility":317,"status":8,"city":318,"state":319,"zip":320,"country":304,"geoPoint":321},"Te Whato Ora, Health New Zealand, Waikato Hospital","Hamilton","Waikato Region","3204",{"lat":322,"lon":323},-37.78333,175.28333,{"facility":325,"status":8,"city":326,"state":327,"zip":328,"country":329,"geoPoint":330},"Unidade Local de Saúde de Santo António - Hospital de Santo António","Porto","Porto District","4099-001","Portugal",{"lat":331,"lon":332},41.1485,-8.61097,{"facility":334,"status":8,"city":335,"zip":336,"country":337,"geoPoint":338},"Chonnam National University Hospital","Gwangju","61469","South Korea",{"lat":339,"lon":340},35.15472,126.91556,{"facility":342,"status":8,"city":343,"zip":344,"country":337,"geoPoint":345},"Samsung Medical Center","Seoul","06351",{"lat":346,"lon":347},37.566,126.9784,{"facility":349,"status":8,"city":350,"state":351,"zip":352,"country":353,"geoPoint":354},"Hospital Universitario Virgen de la Victoria","Málaga","Andalusia","29010","Spain",{"lat":355,"lon":356},36.72016,-4.42034,{"facility":358,"status":8,"city":359,"state":359,"zip":360,"country":353,"geoPoint":361},"Hospital Clínic de Barcelona","Barcelona","08036",{"lat":362,"lon":363},41.38879,2.15899,{"facility":365,"status":8,"city":366,"state":367,"zip":368,"country":353,"geoPoint":369},"Hospital Universitario Marqués De Valdecilla","Santander","Cantabria","39008",{"lat":370,"lon":371},43.46589,-3.80493,{"facility":373,"status":8,"city":359,"state":374,"zip":375,"country":353,"geoPoint":376},"Hospital Universitari Vall d'Hebron","Catalonia","08035",{"lat":362,"lon":363},{"facility":378,"status":8,"city":379,"state":379,"zip":380,"country":353,"geoPoint":381},"Hospital Universitario Doce de Octubre","Madrid","28041",{"lat":382,"lon":383},40.4165,-3.70256,{"facility":385,"status":8,"city":379,"state":379,"zip":386,"country":353,"geoPoint":387},"Hospital Universitario la Paz","28046",{"lat":382,"lon":383},{"facility":389,"status":8,"city":390,"state":391,"zip":392,"country":353,"geoPoint":393},"Hospital Costa del Sol","Marbella","Malaga","29603",{"lat":394,"lon":395},36.51543,-4.88583,{"facility":397,"status":8,"city":398,"state":399,"zip":400,"country":353,"geoPoint":401},"Hospital Universitario Virgen Macarena","Seville","Sevilla","41009",{"lat":402,"lon":403},37.38283,-5.97317,{"facility":405,"status":8,"city":406,"state":406,"zip":407,"country":353,"geoPoint":408},"Hospital General Universitario de Toledo","Toledo","45007",{"lat":409,"lon":410},39.8581,-4.02263,{"facility":412,"status":8,"city":413,"state":413,"zip":414,"country":353,"geoPoint":415},"Hospital Universitari i Politecnic La Fe de Valencia","Valencia","46026",{"lat":416,"lon":417},39.47391,-0.37966,{"facility":419,"status":8,"city":420,"state":421,"zip":422,"country":423,"geoPoint":424},"Royal Papworth Hospital","Cambridge","Cambridgeshire","CB2 0AY","United Kingdom",{"lat":425,"lon":426},52.2,0.11667,{"facility":428,"status":8,"city":429,"state":430,"zip":431,"country":423,"geoPoint":432},"Golden Jubilee National Hospital","Glasgow","West Dunbartonshire","G81 4DY",{"lat":433,"lon":434},55.86515,-4.25763,{"facility":436,"status":8,"city":437,"zip":438,"country":423,"geoPoint":439},"Imperial College Healthcare NHS Trust","London","W12 0HS",{"lat":440,"lon":441},51.50853,-0.12574,[443],{"name":444,"role":445,"phone":446,"email":447},"Medical Director, Inhibikase Therapeutics","CONTACT","1-302-295-3800","info@inhibikase.com",[],[],[],{"nct_id":4,"conditions":452,"biomarkers":453},[19],[],{"nct_id":4,"found":15,"summary":455,"prompt_version":465},{"design":456,"status":457,"heading":458,"summary":459,"follow_up":460,"word_count":461,"commitments":462,"compensation":463,"drugs_mentioned":464},"This is a randomized, double-blind study with two parts, comparing IKT-001 to a placebo. It plans to include up to 486 participants.","completed","IKT-001 for Pulmonary Arterial Hypertension (PAH)","This study is testing a new medication called IKT-001 for people with Pulmonary Arterial Hypertension (PAH), a condition where blood pressure in the arteries of the lungs is too high. Researchers want to see if IKT-001 can improve lung blood vessel resistance and PAH symptoms compared to a placebo (an inactive pill). You might be able to join if you are between 18 and 75 years old and have a specific type of PAH (WHO Group 1). The study aims to enroll 486 participants. The current status of the study is unclear, so it's not known if they are actively recruiting.","The primary outcomes are measured up to Week 24 after starting treatment.",101,"Not specified in the trial record.","Not stated in the trial record.",[31,35],"v2"]