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Clinical Trials in the USA / NCT07365332
Recruiting Phase 3

An Adaptive Program of IKT-001 in Pulmonary Arterial Hypertension (PAH)

NCT07365332 · tracked via the Priya Life Science USA tracker
Sponsor
Inhibikase Therapeutics
Phase
Phase 3
Started
2026-04-23
Last updated
2026-09-02

Condition(s) studied

Pulmonary Arterial Hypertension

Investigational drug(s) / intervention(s)

IKT-001Placebo

IKT-001: IKT-001 tablets for PO administration

Placebo: Placebo to IKT-001 tablets for PO administration

Study summary

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
Inclusion Criteria: * Documented diagnosis of WHO PAH Group 1 in any of the following subtypes: * Idiopathic PAH * Heritable PAH * Drug/toxin-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/m\^2 and ≤35.0 kg/m\^2 at screening. * 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 * 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 Exclusion Criteria: * 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 \<90 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) \<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. * 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/or 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.

Primary outcome measure(s)

Trial sites (43)

FacilityCityRegionStatus
Arizona Pulmonary Specialists, LTD Scottsdale Arizona Recruiting
Cedars Sinai Beverly Hills California Recruiting
Jeffrey S. Sager, MD Medical Corporation Santa Barbara California Recruiting
Lundquist at Harbor UCLA Torrance California Recruiting
University of Colorado Anschutz Medical Campus Aurora Colorado Recruiting
University of Kansas Medical Center Kansas City Kansas Recruiting
Norton Healthcare Louisville Kentucky Recruiting
Tufts Medical Center Boston Massachusetts Recruiting
Washington University School of Medicine St Louis Missouri Recruiting
NYU Langone Health New York New York Recruiting
Westchester Medical Center Valhalla New York Recruiting
Duke University Durham North Carolina Recruiting
University of Cincinnati Cincinnati Ohio Recruiting
Vanderbilt University Medical Center Nashville Tennessee Recruiting
UT Southwestern Medical Center Dallas Texas Recruiting
Sanatorio de la Trinidad Palermo Buenos Aires Buenos Aires Recruiting
Pulmonary Hypertension Research Queensland PHRQ Auchenflower Queensland Recruiting
Hôpital Universitaire de Bruxelles - Erasme Anderlecht Brussels Capital Recruiting
University of Alberta Hospital Edmonton Alberta Recruiting
Hôpital Bicêtre Le Kremlin-Bicêtre France Recruiting
CHRU Strasbourg Strasbourg Grand Est Recruiting
Medizinische Hochschule Hannover, Abteilung Pneumologie und Infektiologie Hanover Lower Saxony Recruiting
Fondazione IRCCS San Gerardo dei Tintori Monza Monza and Brianza Recruiting
Amsterdam UMC site VUMC Amsterdam North Holland Recruiting
Auckland City Hospital Auckland Auckland Recruiting
University of Otago Christchurch Christchurch Canterbury Recruiting
Te Whato Ora, Health New Zealand, Waikato Hospital Hamilton Waikato Region Recruiting
Unidade Local de Saúde de Santo António - Hospital de Santo António Porto Porto District Recruiting
Chonnam National University Hospital Gwangju South Korea Recruiting
Samsung Medical Center Seoul South Korea Recruiting
Hospital Universitario Virgen de la Victoria Málaga Andalusia Recruiting
Hospital Clínic de Barcelona Barcelona Barcelona Recruiting
Hospital Universitario Marqués De Valdecilla Santander Cantabria Recruiting
Hospital Universitari Vall d'Hebron Barcelona Catalonia Recruiting
Hospital Universitario Doce de Octubre Madrid Madrid Recruiting
Hospital Universitario la Paz Madrid Madrid Recruiting
Hospital Costa del Sol Marbella Malaga Recruiting
Hospital Universitario Virgen Macarena Seville Sevilla Recruiting
Hospital General Universitario de Toledo Toledo Toledo Recruiting
Hospital Universitari i Politecnic La Fe de Valencia Valencia Valencia Recruiting

+ 3 more sites — see the full list on the official registry below.

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07365332 on ClinicalTrials.gov ↗ ← All trials in the USA