Ignite Creation Date:
2026-03-26 @ 3:16 PM
Ignite Modification Date:
2026-03-30 @ 12:14 AM
Study NCT ID:
NCT07365332
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-01-27
First Post:
2026-01-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
An Adaptive Program of IKT-001 in Pulmonary Arterial Hypertension (PAH)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000081029', 'term': 'Pulmonary Arterial Hypertension'}], 'ancestors': [{'id': 'D006976', 'term': 'Hypertension, Pulmonary'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Adaptive, 2-part, randomized, multicenter, double-blind, placebo-controlled, parallel-group study'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 486}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-03', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-01', 'completionDateStruct': {'date': '2029-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-01-23', 'studyFirstSubmitDate': '2026-01-22', 'studyFirstSubmitQcDate': '2026-01-22', 'lastUpdatePostDateStruct': {'date': '2026-01-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-01-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2029-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '[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', 'timeFrame': 'Baseline to Week 24', 'description': 'Change in Pulmonary Vascular Resistance (PVR)'}, {'measure': '[Part B] To characterize the effects of IKT-001 on symptoms and characteristics of Pulmonary Arterial Hypertension compared to placebo', 'timeFrame': 'Baseline to Week 24', 'description': 'Change in 6-minute walk distance (6MWD)'}], 'secondaryOutcomes': [{'measure': 'To characterize the effects of IKT-001 on WHO Functional Class', 'timeFrame': 'Baseline up to Week 48', 'description': 'Change in WHO Functional Class'}, {'measure': 'To characterize the effects of IKT-001 on time to clinical worsening', 'timeFrame': 'Baseline up to Week 48', 'description': 'Time to clinical worsening'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Pulmonary Arterial Hypertension']}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "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/toxin-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/m\\^2 and ≤35.0 kg/m\\^2 at screening.\n* Baseline RHC performed during the Screening Period documenting a PVR of ≥ 400 dyn/sec/cm\\^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/sec/cm\\^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 \\<90 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) \\<70 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/or 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."}, 'identificationModule': {'nctId': 'NCT07365332', 'acronym': 'IMPROVE-PAH', 'briefTitle': 'An Adaptive Program of IKT-001 in Pulmonary Arterial Hypertension (PAH)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Inhibikase Therapeutics'}, 'officialTitle': 'An Adaptive, 2-Part, Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate the Efficacy and Safety of IKT-001 in Pulmonary Arterial Hypertension (PAH)', 'orgStudyIdInfo': {'id': 'IKT-001-201'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'IKT-001', 'description': 'IKT-001 tablets for PO administration', 'interventionNames': ['Drug: IKT-001']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Matching placebo to IKT-001 tablets for PO administration', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'IKT-001', 'type': 'DRUG', 'description': 'IKT-001 tablets for PO administration', 'armGroupLabels': ['IKT-001']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo to IKT-001 tablets for PO administration', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Medical Director, Inhibikase Therapeutics', 'role': 'CONTACT', 'email': 'info@inhibikase.com', 'phone': '1-302-295-3800'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Inhibikase Therapeutics', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}