RecruitingPhase 3NCT07365332

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)

Sponsor

Inhibikase Therapeutics

Enrollment

486 participants

Start Date

Apr 23, 2026

Study Type

INTERVENTIONAL

Conditions

Pulmonary Arterial Hypertension

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

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called IKT-001 and a drug called Placebo for people with pulmonary arterial hypertension. The study is currently recruiting participants at 2 locations. People eligible for this study include aged 18 Years to 75 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGIKT-001

IKT-001 tablets for PO administration

DRUGPlacebo

Placebo to IKT-001 tablets for PO administration

Locations(43)

Arizona Pulmonary Specialists, LTD

Scottsdale, Arizona, United States

Cedars Sinai

Beverly Hills, California, United States

Jeffrey S. Sager, MD Medical Corporation

Santa Barbara, California, United States

Lundquist at Harbor UCLA

Torrance, California, United States

University of Colorado Anschutz Medical Campus

Aurora, Colorado, United States

University of Kansas Medical Center

Kansas City, Kansas, United States

Norton Healthcare

Louisville, Kentucky, United States

Tufts Medical Center

Boston, Massachusetts, United States

Washington University School of Medicine

St Louis, Missouri, United States

NYU Langone Health

New York, New York, United States

Westchester Medical Center

Valhalla, New York, United States

Duke University

Durham, North Carolina, United States

University of Cincinnati

Cincinnati, Ohio, United States

Vanderbilt University Medical Center

Nashville, Tennessee, United States

UT Southwestern Medical Center

Dallas, Texas, United States

Sanatorio de la Trinidad Palermo

Buenos Aires, Buenos Aires, Argentina

Pulmonary Hypertension Research Queensland PHRQ

Auchenflower, Queensland, Australia

Hôpital Universitaire de Bruxelles - Erasme

Anderlecht, Brussels Capital, Belgium

University of Alberta Hospital

Edmonton, Alberta, Canada

Hôpital Bicêtre

Le Kremlin-Bicêtre, France, France

CHRU Strasbourg

Strasbourg, Grand Est, France

Medizinische Hochschule Hannover, Abteilung Pneumologie und Infektiologie

Hanover, Lower Saxony, Germany

Fondazione IRCCS San Gerardo dei Tintori

Monza, Monza and Brianza, Italy

Amsterdam UMC site VUMC

Amsterdam, North Holland, Netherlands

Auckland City Hospital

Auckland, Auckland, New Zealand

University of Otago Christchurch

Christchurch, Canterbury, New Zealand

Te Whato Ora, Health New Zealand, Waikato Hospital

Hamilton, Waikato Region, New Zealand

Unidade Local de Saúde de Santo António - Hospital de Santo António

Porto, Porto District, Portugal

Chonnam National University Hospital

Gwangju, South Korea

Samsung Medical Center

Seoul, South Korea

Hospital Universitario Virgen de la Victoria

Málaga, Andalusia, Spain

Hospital Clínic de Barcelona

Barcelona, Barcelona, Spain

Hospital Universitario Marqués De Valdecilla

Santander, Cantabria, Spain

Hospital Universitari Vall d'Hebron

Barcelona, Catalonia, Spain

Hospital Universitario Doce de Octubre

Madrid, Madrid, Spain

Hospital Universitario la Paz

Madrid, Madrid, Spain

Hospital Costa del Sol

Marbella, Malaga, Spain

Hospital Universitario Virgen Macarena

Seville, Sevilla, Spain

Hospital General Universitario de Toledo

Toledo, Toledo, Spain

Hospital Universitari i Politecnic La Fe de Valencia

Valencia, Valencia, Spain

Royal Papworth Hospital

Cambridge, Cambridgeshire, United Kingdom

Golden Jubilee National Hospital

Glasgow, West Dunbartonshire, United Kingdom

Imperial College Healthcare NHS Trust

London, United Kingdom

View Full Details on ClinicalTrials.gov

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NCT07365332

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