A Study of AV-101 (Dry Powder Inhaled Imatinib) in Patients With Pulmonary Arterial Hypertension (PAH)

Last updated: August 22, 2024
Sponsor: Aerovate Therapeutics
Overall Status: Terminated

Phase

2/3

Condition

Vascular Diseases

Stress

Pulmonary Arterial Hypertension

Treatment

Placebo

AV-101

Clinical Study ID

NCT05036135
AV-101-002
  • Ages 18-75
  • All Genders

Study Summary

IMPAHCT: Inhaled iMatinib Pulmonary Arterial Hypertension Clinical Trial is a Phase 2b/Phase 3 study to evaluate the safety and efficacy of AV-101 (dry powder inhaled imatinib) in patients with Pulmonary Arterial Hypertension (PAH). The Phase 2b part of the study will assess three doses to establish an optimal dose for the Phase 3 part of the study. The Phase 2b primary endpoint will be the placebo corrected change in pulmonary vascular resistance (PVR). The Phase 3 primary endpoint will be the placebo corrected change in 6-minute walk distance (6MWD) after 24 weeks of treatment.

Eligibility Criteria

Inclusion

Key Inclusion Criteria

  • PAH belonging to one of the subgroups:
  1. I/HPAH, PAH-CTD,

  2. PAH due to drugs and/or toxins/chemicals (having been in the care of the investigator for at least one year with no relapses of drug or toxin/chemical abuse),

  3. HIV associated or

  4. PAH due to repaired congenital heart disease (at least 1 year since repair)

  • World Health Organization (WHO) Functional Class II, III or IV symptoms

  • Stable concomitant background therapy of at least one PAH approved medications

  • Able to walk a distance of at least 100 m but no more than 475 m during the Screening 6-minute walk tests.

Key Exclusion Criteria

  • Pulmonary hypertension (PH) belonging to Groups 2 to 5

  • A history of left-sided heart disease

  • Pregnant or breast-feeding females

Additional criteria may apply, per protocol

Study Design

Total Participants: 202
Treatment Group(s): 2
Primary Treatment: Placebo
Phase: 2/3
Study Start date:
December 02, 2021
Estimated Completion Date:
August 09, 2024

Connect with a study center

  • Hospital Britanico de Buenos Aires

    Buenos Aires, 1134
    Argentina

    Site Not Available

  • Nexo Salud Investigación Clínica

    Buenos Aires, 1425
    Argentina

    Site Not Available

  • Sanatorio de la Trinidad Mitre

    Buenos Aires, C1039AAO
    Argentina

    Site Not Available

  • Cardiología Palermo

    Caba, 1425
    Argentina

    Site Not Available

  • Hospital Italiano de Cordoba

    Córdoba, X5004FJE
    Argentina

    Site Not Available

  • Insituto Medico DAMIC

    Córdoba, 5009
    Argentina

    Site Not Available

  • Hospital Dr. Jose Maria Cullen

    Santa Fe, S300EOZ
    Argentina

    Site Not Available

  • Royal Prince Alfred Hospital

    Camperdown, New South Wales 2050
    Australia

    Site Not Available

  • Concord Repatriation General Hospital

    Concord West, New South Wales 2138
    Australia

    Site Not Available

  • Nepean Hospital

    Kingswood, New South Wales 2747
    Australia

    Site Not Available

  • Westmead Hospital

    Westmead, New South Wales 2145
    Australia

    Site Not Available

  • Sunshine Coast University Hospital

    Birtinya, Queensland 4575
    Australia

    Site Not Available

  • The Prince Charles Hospital

    Chermside, Queensland 4032
    Australia

    Site Not Available

  • The Alfred Hospital

    Melbourne, Victoria 3004
    Australia

    Site Not Available

  • Royal Adelaide Hospital

    Adelaide, 5000
    Australia

    Site Not Available

  • Fiona Stanley Hospital

    Murdoch, 6150
    Australia

    Site Not Available

  • AKH - Medizinische Universitat Wien

    Vienna, 1090
    Austria

    Site Not Available

  • Hopital Erasme - Cliniques Universitaires de Bruxelles

    Brussels, 1070
    Belgium

    Site Not Available

  • UZ Leuven

    Leuven, 3000
    Belgium

    Site Not Available

  • Santa Casa de Misericordia de Porto Alegre

    Porto Alegre, 90035-074
    Brazil

    Site Not Available

  • Heart Institute - University of Sao Paulo

    São Paulo, 05403
    Brazil

    Site Not Available

  • The Governors of the University of Calgary

    Calgary, Alberta T2N 1N4
    Canada

    Site Not Available

  • University of Alberta Hospital

    Edmonton, Alberta T6G 2B7
    Canada

    Site Not Available

  • London Health Science Centre

    London, Ontario N6A 5W9
    Canada

    Site Not Available

  • Jewish General Hospital

    Montréal, Quebec H3T 1E2
    Canada

    Site Not Available

  • Centro de Investigaciones Clinicas de la Universidad Catolica

    Santiago, 8330024
    Chile

    Site Not Available

  • Peking Union Medical College Hospital

    Beijing, 100730
    China

    Site Not Available

  • Chongqing Medical University - The First Affiliated Hospital

    Chongqing, 40016
    China

    Site Not Available

  • Guangdong Provincial People's Hospital

    Guangdong, 510000
    China

    Site Not Available

  • Central South University - The Second Xiangya Hospital

    Hunan, 410011
    China

    Site Not Available

  • Yanan Hospital of Kunming City

    Kunming, 650051
    China

    Site Not Available

  • Gansu Provincial People's Hospital

    Lanzhou, 730000
    China

    Site Not Available

  • Southeast University (SEU) - Zhongda Hospital

    Nanjing, 210009
    China

    Site Not Available

  • Shanghai Pulmonary Hospital

    Shanghai, 200437
    China

    Site Not Available

  • Tianjin Medical University General Hospital

    Tianjin, 300052
    China

    Site Not Available

  • Vseobecna fakultni nemocnice v Praze

    Praha, 128 21
    Czechia

    Site Not Available

  • Groupement Hospitalier Sud - Hôpital Bicêtre

    Le Kremlin-Bicêtre, Cedex 94275
    France

    Site Not Available

  • Hôpital Cardio-Vasculaire et Pneumologique Louis Pradel

    Bron, 69677
    France

    Site Not Available

  • Hôpital Nord - CHU Marseille

    Marseille, 94275
    France

    Site Not Available

  • Hopital Arnaud de Villeneuve

    Montpellier, 34295
    France

    Site Not Available

  • Les Hôpitaux Universitaires de Strasbourg

    Strasbourg, 67091
    France

    Site Not Available

  • Universitaetsklinikum Carl Gustav Carus TU Dresden

    Dresden, 1307
    Germany

    Site Not Available

  • Universitaetsklinikum Giessen und Marburg GmbH Standort Giessen

    Giesen, 35292
    Germany

    Site Not Available

  • Universitaetsklinikum Heidelberg

    Heidelberg, 69126
    Germany

    Site Not Available

  • München Klinik Bogenhausen

    München, 81925
    Germany

    Site Not Available

  • University General Hospital Attikon

    Athens, 10676
    Greece

    Site Not Available

  • Cardiosurgery Hospital

    Kallithéa, 17674
    Greece

    Site Not Available

  • AHEPA General Hospital of Thessaloniki

    Thessaloníki, 54637
    Greece

    Site Not Available

  • The Lady Davis Carmel Medical Center

    Haifa, 34362
    Israel

    Site Not Available

  • Hadassah University Hospital - Ein Kerem

    Jerusalem, 91999
    Israel

    Site Not Available

  • Tel Aviv Sourasky Medical Center

    Tel Aviv, 64239
    Israel

    Site Not Available

  • Azienda Ospedaliero Universitaria Ospedali Riuniti - Foggia

    Foggia, 71122
    Italy

    Site Not Available

  • Ospedale San Giuseppe - Fatebenefratelli

    Milan, 20123
    Italy

    Site Not Available

  • Azienda Socio Sanitaria Territoriale di Monza

    Monza, 20900
    Italy

    Site Not Available

  • Azienda Ospedaliera Vincenzo Monaldi

    Napoli, 80131
    Italy

    Site Not Available

  • Istituto Mediterraneo per i Trapianti e Terapie ad Alta Specializzazione

    Palermo, 90127
    Italy

    Site Not Available

  • Fondazione IRCCS Policlinico San Matteo

    Pavia, 27100
    Italy

    Site Not Available

  • Azienda Ospedaliera Universitaria Policlinico Umberto I

    Rome, 137
    Italy

    Site Not Available

  • Pauls Stradins Clinical University Hospital

    Riga, 1002
    Latvia

    Site Not Available

  • CICUM San Miguel

    Guadalajara, Jalisco 44160
    Mexico

    Site Not Available

  • Unidad de Investigacion Clinica en Medicina S.C.

    Monterrey, Nuevo León 64718
    Mexico

    Site Not Available

  • Instituto Nacional de Cardiologia Dr Ignacio Chavez Rivera

    Mexico City, 14080
    Mexico

    Site Not Available

  • Universidad Autonoma de Nuevo Leon, Hospital Universitario

    Monterrey, 64460
    Mexico

    Site Not Available

  • Amsterdam UMC, Locatie VUMC

    Amsterdam, 1081 HV
    Netherlands

    Site Not Available

  • Krakowski Szpital Specjalistyczny im. Jana Pawla II

    Krakow, 31-202
    Poland

    Site Not Available

  • Szpital Kliniczny Przemienienia Pańskiego UM im. Marcinkowskiego

    Poznań, 61-848
    Poland

    Site Not Available

  • Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego

    Wrocław, 50-556
    Poland

    Site Not Available

  • Bieganski Provincial Specialist Hospital

    Łódź, 91-347
    Poland

    Site Not Available

  • Hospital Garcia de Orta, EPE

    Almada, 2805-267
    Portugal

    Site Not Available

  • Hospital Pulido Valente

    Lisboa, 1649-035
    Portugal

    Site Not Available

  • CHUPorto

    Porto, 4099-001
    Portugal

    Site Not Available

  • Cardiopulmonary Research Center

    Guaynabo, 00968
    Puerto Rico

    Site Not Available

  • National University Hospital

    Singapore, 119074
    Singapore

    Site Not Available

  • Tan Tock Seng Hospital

    Singapore, 308433
    Singapore

    Site Not Available

  • Center of Chest Disease Johannesburg

    Johannesburg, 2193
    South Africa

    Site Not Available

  • Hospital Clinic de Barcelona

    Barcelona, 8036
    Spain

    Site Not Available

  • Hospital Universitari Vall d'Hebron

    Barcelona, 08035
    Spain

    Site Not Available

  • Hosp. Universitario Gran Canaria Doctor Negrin

    Las Palmas de Gran Canaria, 35010
    Spain

    Site Not Available

  • Hospital 12 de Octubre

    Madrid, 28014
    Spain

    Site Not Available

  • Universidad Autonoma de Madrid

    Madrid, 28046
    Spain

    Site Not Available

  • Hospital Universitario Virgen de la Victoria

    Málaga, 29071
    Spain

    Site Not Available

  • Hospital universtario de Salamanca

    Salamanca, 37007
    Spain

    Site Not Available

  • Hosp. Universitario Marques de Valdecilla

    Santander, 39003
    Spain

    Site Not Available

  • Hospital Universitario de Toledo

    Toledo, 45007
    Spain

    Site Not Available

  • Norrlands Universitetssjukhus

    Umeå, 907 37
    Sweden

    Site Not Available

  • Imperial College Healthcare NHS Trust

    London, England W12 0HS
    United Kingdom

    Site Not Available

  • Golden Jubilee National Hospital

    Glasgow, G81 4DY
    United Kingdom

    Site Not Available

  • Royal Brompton Hospital

    London, SW3 6HP
    United Kingdom

    Site Not Available

  • The Newcastle upon Tyne Hospitals NHS Foundation Trust

    Newcastle, NE7 7DN
    United Kingdom

    Site Not Available

  • Arizona Pulmonary Specialists, Ltd.

    Phoenix, Arizona 85012
    United States

    Site Not Available

  • University of Arizona, Department of Medicine

    Tucson, Arizona 85724
    United States

    Site Not Available

  • Cedars-Sinai Medical Center, Pulmonary & Critical Care

    Los Angeles, California 90048
    United States

    Site Not Available

  • Dept of Veterans Affairs Greater Los Angeles Healthcare System

    Los Angeles, California 90073
    United States

    Site Not Available

  • Kaiser Permanente Los Angeles Medical Center

    Los Angeles, California 90027
    United States

    Site Not Available

  • UCLA/David Geffen School of Medicine-Pulmonary and Criticial Care

    Los Angeles, California 90024
    United States

    Site Not Available

  • UC Davis Medical Center

    Sacramento, California 95817
    United States

    Site Not Available

  • University of California

    San Francisco, California 94143
    United States

    Site Not Available

  • LA Biomedical Research Institute Harbor

    Torrance, California 90509
    United States

    Site Not Available

  • University of Colorado Denver

    Aurora, Colorado 80045
    United States

    Site Not Available

  • National Jewish Health

    Denver, Colorado 80206
    United States

    Site Not Available

  • George Washington University Medical Faculty Associates, Inc.

    Washington, District of Columbia 20073
    United States

    Site Not Available

  • Georgetown University Hospital

    Washington, District of Columbia 20007
    United States

    Site Not Available

  • Mayo Clinic Florida

    Jacksonville, Florida 32224
    United States

    Site Not Available

  • Orlando Heart Center

    Orlando, Florida 32804
    United States

    Site Not Available

  • Emory University

    Atlanta, Georgia 30322
    United States

    Site Not Available

  • Indiana University Health

    Indianapolis, Indiana 46202
    United States

    Site Not Available

  • University of Iowa Hospitals & Clinics

    Iowa City, Iowa 52242
    United States

    Site Not Available

  • University of Kansas Medical Center

    Kansas City, Kansas 66160
    United States

    Site Not Available

  • Louisiana State University health Sciences Center

    Shreveport, Louisiana 71103
    United States

    Site Not Available

  • Tufts Medical Center, Inc.

    Boston, Massachusetts 02111
    United States

    Site Not Available

  • University of Michigan

    Ann Arbor, Michigan 48109
    United States

    Site Not Available

  • University of Minnesota

    Minneapolis, Minnesota 55455
    United States

    Site Not Available

  • Washington University School of Medicine

    Saint Louis, Missouri 63110
    United States

    Site Not Available

  • University of Nebraska Medical Center- Hematology/Oncology Section

    Omaha, Nebraska 68198
    United States

    Site Not Available

  • The Unviersity of New Mexico - UNM Hospitals

    Albuquerque, New Mexico 87131
    United States

    Site Not Available

  • New York-Presbyterian Brooklyn Methodist Hospital

    Brooklyn, New York 11215
    United States

    Site Not Available

  • NYU Langone Seaport

    New York, New York 10016
    United States

    Site Not Available

  • Duke University Medical Center - Duke South Clinic

    Durham, North Carolina 27710
    United States

    Site Not Available

  • The Lindner Center for Research and Education

    Cincinnati, Ohio 45219
    United States

    Site Not Available

  • University of Cincinnati

    Cincinnati, Ohio 45267
    United States

    Site Not Available

  • The Ohio State University Wexner Medical Center

    Columbus, Ohio 43210
    United States

    Site Not Available

  • Bend Memorial Clinic

    Oregon City, Oregon 97701
    United States

    Site Not Available

  • Hospital of the University of Pennsylvania

    Philadelphia, Pennsylvania 19104
    United States

    Site Not Available

  • Thomas Jefferson University

    Philadelphia, Pennsylvania 19107
    United States

    Site Not Available

  • UPMC Presbyterian Hospital

    Pittsburgh, Pennsylvania 15213
    United States

    Site Not Available

  • Stat Care Pulmonary Consultants, PLLC

    Knoxville, Tennessee 37919
    United States

    Site Not Available

  • Vanderbilt University Medical Center

    Nashville, Tennessee 37232
    United States

    Site Not Available

  • Baylor University Medical Center

    Dallas, Texas 75246
    United States

    Site Not Available

  • Houston Methodist Hospital

    Houston, Texas 77030
    United States

    Site Not Available

  • Inova Heart and Vascular Institute

    Falls Church, Virginia 22042
    United States

    Site Not Available

  • Sentara Medical Group - Sentara Pulmonary & Critical Care Specialists

    Norfolk, Virginia 23507
    United States

    Site Not Available

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