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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years - 75 Years
Gender All
More Inclusion & Exclusion Criteria

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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT05036135
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 2/Phase 3
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Aerovate Therapeutics
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

N/A
Principal Investigator Affiliation N/A
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry
Overall Status Recruiting
Countries Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, China, Czechia, France, Germany, Greece, Israel, Italy, Latvia, Mexico, Netherlands, Poland, Portugal, Puerto Rico, Singapore, South Africa, Spain, Sweden, United Kingdom, United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Pulmonary Arterial Hypertension
Arms & Interventions

Arms

Experimental: Phase 2b low dose AV-101

Experimental: Phase 2b medium dose AV-101

Experimental: Phase 2b high dose AV-101

Placebo Comparator: Phase 2b Placebo

Experimental: Phase 3 dose AV-101 (Optimal dose selected in Phase 2b)

Placebo Comparator: Phase 3 Placebo

Interventions

Drug: - AV-101

AV-101 (imatinib) administered via dry powder inhalation

Drug: - Placebo

Placebo administered via dry powder inhalation

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Arizona Pulmonary Specialists, Ltd., Phoenix, Arizona

Status

Recruiting

Address

Arizona Pulmonary Specialists, Ltd.

Phoenix, Arizona, 85012

Tucson, Arizona

Status

Recruiting

Address

University of Arizona, Department of Medicine

Tucson, Arizona, 85724

Los Angeles, California

Status

Recruiting

Address

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

Los Angeles, California, 90024

Los Angeles, California

Status

Recruiting

Address

Kaiser Permanente Los Angeles Medical Center

Los Angeles, California, 90027

Los Angeles, California

Status

Recruiting

Address

Cedars-Sinai Medical Center, Pulmonary & Critical Care

Los Angeles, California, 90048

Los Angeles, California

Status

Recruiting

Address

Dept of Veterans Affairs Greater Los Angeles Healthcare System

Los Angeles, California, 90073

UC Davis Medical Center, Sacramento, California

Status

Recruiting

Address

UC Davis Medical Center

Sacramento, California, 95817

University of California, San Francisco, California

Status

Recruiting

Address

University of California

San Francisco, California, 94143

LA Biomedical Research Institute Harbor, Torrance, California

Status

Recruiting

Address

LA Biomedical Research Institute Harbor

Torrance, California, 90509

University of Colorado Denver, Aurora, Colorado

Status

Recruiting

Address

University of Colorado Denver

Aurora, Colorado, 80045

National Jewish Health, Denver, Colorado

Status

Recruiting

Address

National Jewish Health

Denver, Colorado, 80206

Georgetown University Hospital, Washington, District of Columbia

Status

Withdrawn

Address

Georgetown University Hospital

Washington, District of Columbia, 20007

Washington, District of Columbia

Status

Recruiting

Address

George Washington University Medical Faculty Associates, Inc.

Washington, District of Columbia, 20073

Mayo Clinic Florida, Jacksonville, Florida

Status

Recruiting

Address

Mayo Clinic Florida

Jacksonville, Florida, 32224

Orlando Heart Center, Orlando, Florida

Status

Recruiting

Address

Orlando Heart Center

Orlando, Florida, 32804

Emory University, Atlanta, Georgia

Status

Recruiting

Address

Emory University

Atlanta, Georgia, 30322

Indiana University Health, Indianapolis, Indiana

Status

Recruiting

Address

Indiana University Health

Indianapolis, Indiana, 46202

University of Iowa Hospitals & Clinics, Iowa City, Iowa

Status

Recruiting

Address

University of Iowa Hospitals & Clinics

Iowa City, Iowa, 52242

University of Kansas Medical Center, Kansas City, Kansas

Status

Recruiting

Address

University of Kansas Medical Center

Kansas City, Kansas, 66160

Shreveport, Louisiana

Status

Withdrawn

Address

Louisiana State University health Sciences Center

Shreveport, Louisiana, 71103

Tufts Medical Center, Inc., Boston, Massachusetts

Status

Recruiting

Address

Tufts Medical Center, Inc.

Boston, Massachusetts, 02111

University of Michigan, Ann Arbor, Michigan

Status

Recruiting

Address

University of Michigan

Ann Arbor, Michigan, 48109

University of Minnesota, Minneapolis, Minnesota

Status

Recruiting

Address

University of Minnesota

Minneapolis, Minnesota, 55455

Washington University School of Medicine, Saint Louis, Missouri

Status

Recruiting

Address

Washington University School of Medicine

Saint Louis, Missouri, 63110

Omaha, Nebraska

Status

Recruiting

Address

University of Nebraska Medical Center- Hematology/Oncology Section

Omaha, Nebraska, 68198

Albuquerque, New Mexico

Status

Recruiting

Address

The Unviersity of New Mexico - UNM Hospitals

Albuquerque, New Mexico, 87131

Brooklyn, New York

Status

Recruiting

Address

New York-Presbyterian Brooklyn Methodist Hospital

Brooklyn, New York, 11215

NYU Langone Seaport, New York, New York

Status

Recruiting

Address

NYU Langone Seaport

New York, New York, 10016

Durham, North Carolina

Status

Recruiting

Address

Duke University Medical Center - Duke South Clinic

Durham, North Carolina, 27710

Cincinnati, Ohio

Status

Recruiting

Address

The Lindner Center for Research and Education

Cincinnati, Ohio, 45219

University of Cincinnati, Cincinnati, Ohio

Status

Recruiting

Address

University of Cincinnati

Cincinnati, Ohio, 45267

Columbus, Ohio

Status

Recruiting

Address

The Ohio State University Wexner Medical Center

Columbus, Ohio, 43210

Bend Memorial Clinic, Oregon City, Oregon

Status

Recruiting

Address

Bend Memorial Clinic

Oregon City, Oregon, 97701

Philadelphia, Pennsylvania

Status

Recruiting

Address

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104

Thomas Jefferson University, Philadelphia, Pennsylvania

Status

Recruiting

Address

Thomas Jefferson University

Philadelphia, Pennsylvania, 19107

UPMC Presbyterian Hospital, Pittsburgh, Pennsylvania

Status

Recruiting

Address

UPMC Presbyterian Hospital

Pittsburgh, Pennsylvania, 15213

Stat Care Pulmonary Consultants, PLLC, Knoxville, Tennessee

Status

Recruiting

Address

Stat Care Pulmonary Consultants, PLLC

Knoxville, Tennessee, 37919

Vanderbilt University Medical Center, Nashville, Tennessee

Status

Recruiting

Address

Vanderbilt University Medical Center

Nashville, Tennessee, 37232

Baylor University Medical Center, Dallas, Texas

Status

Recruiting

Address

Baylor University Medical Center

Dallas, Texas, 75246

Houston Methodist Hospital, Houston, Texas

Status

Recruiting

Address

Houston Methodist Hospital

Houston, Texas, 77030

Inova Heart and Vascular Institute, Falls Church, Virginia

Status

Withdrawn

Address

Inova Heart and Vascular Institute

Falls Church, Virginia, 22042

Norfolk, Virginia

Status

Recruiting

Address

Sentara Medical Group - Sentara Pulmonary & Critical Care Specialists

Norfolk, Virginia, 23507

International Sites

Hospital Britanico de Buenos Aires, Buenos Aires, Argentina

Status

Recruiting

Address

Hospital Britanico de Buenos Aires

Buenos Aires, , 1134

Nexo Salud Investigación Clínica, Buenos Aires, Argentina

Status

Recruiting

Address

Nexo Salud Investigación Clínica

Buenos Aires, , 1425

Sanatorio de la Trinidad Mitre, Buenos Aires, Argentina

Status

Recruiting

Address

Sanatorio de la Trinidad Mitre

Buenos Aires, , C1039AAO

Cardiología Palermo, Caba, Argentina

Status

Recruiting

Address

Cardiología Palermo

Caba, , 1425

Insituto Medico DAMIC, Córdoba, Argentina

Status

Recruiting

Address

Insituto Medico DAMIC

Córdoba, , 5009

Hospital Italiano de Cordoba, Córdoba, Argentina

Status

Recruiting

Address

Hospital Italiano de Cordoba

Córdoba, , X5004FJE

Hospital Dr. Jose Maria Cullen, Santa Fe, Argentina

Status

Recruiting

Address

Hospital Dr. Jose Maria Cullen

Santa Fe, , S300EOZ

Royal Prince Alfred Hospital, Camperdown, New South Wales, Australia

Status

Recruiting

Address

Royal Prince Alfred Hospital

Camperdown, New South Wales, 2050

Concord Repatriation General Hospital, Concord West, New South Wales, Australia

Status

Recruiting

Address

Concord Repatriation General Hospital

Concord West, New South Wales, 2138

Nepean Hospital, Kingswood, New South Wales, Australia

Status

Recruiting

Address

Nepean Hospital

Kingswood, New South Wales, 2747

Westmead Hospital, Westmead, New South Wales, Australia

Status

Recruiting

Address

Westmead Hospital

Westmead, New South Wales, 2145

Sunshine Coast University Hospital, Birtinya, Queensland, Australia

Status

Recruiting

Address

Sunshine Coast University Hospital

Birtinya, Queensland, 4575

The Prince Charles Hospital, Chermside, Queensland, Australia

Status

Recruiting

Address

The Prince Charles Hospital

Chermside, Queensland, 4032

The Alfred Hospital, Melbourne, Victoria, Australia

Status

Recruiting

Address

The Alfred Hospital

Melbourne, Victoria, 3004

Royal Adelaide Hospital, Adelaide, Australia

Status

Recruiting

Address

Royal Adelaide Hospital

Adelaide, , 5000

Fiona Stanley Hospital, Murdoch, Australia

Status

Recruiting

Address

Fiona Stanley Hospital

Murdoch, , 6150

AKH - Medizinische Universitat Wien, Vienna, Austria

Status

Recruiting

Address

AKH - Medizinische Universitat Wien

Vienna, , 1090

Brussels, Belgium

Status

Recruiting

Address

Hopital Erasme - Cliniques Universitaires de Bruxelles

Brussels, , 1070

UZ Leuven, Leuven, Belgium

Status

Recruiting

Address

UZ Leuven

Leuven, , 3000

Porto Alegre, Brazil

Status

Recruiting

Address

Santa Casa de Misericordia de Porto Alegre

Porto Alegre, , 90035-074

São Paulo, Brazil

Status

Recruiting

Address

Heart Institute - University of Sao Paulo

São Paulo, , 05403

Calgary, Alberta, Canada

Status

Recruiting

Address

The Governors of the University of Calgary

Calgary, Alberta, T2N 1N4

University of Alberta Hospital, Edmonton, Alberta, Canada

Status

Recruiting

Address

University of Alberta Hospital

Edmonton, Alberta, T6G 2B7

London Health Science Centre, London, Ontario, Canada

Status

Recruiting

Address

London Health Science Centre

London, Ontario, N6A 5W9

Jewish General Hospital, Montréal, Quebec, Canada

Status

Recruiting

Address

Jewish General Hospital

Montréal, Quebec, H3T 1E2

Santiago, Chile

Status

Recruiting

Address

Centro de Investigaciones Clinicas de la Universidad Catolica

Santiago, , 8330024

Peking Union Medical College Hospital, Beijing, China

Status

Recruiting

Address

Peking Union Medical College Hospital

Beijing, , 100730

Chongqing, China

Status

Recruiting

Address

Chongqing Medical University - The First Affiliated Hospital

Chongqing, , 40016

Guangdong Provincial People's Hospital, Guangdong, China

Status

Recruiting

Address

Guangdong Provincial People's Hospital

Guangdong, , 510000

Hunan, China

Status

Recruiting

Address

Central South University - The Second Xiangya Hospital

Hunan, , 410011

Yanan Hospital of Kunming City, Kunming, China

Status

Recruiting

Address

Yanan Hospital of Kunming City

Kunming, , 650051

Gansu Provincial People's Hospital, Lanzhou, China

Status

Recruiting

Address

Gansu Provincial People's Hospital

Lanzhou, , 730000

Nanjing, China

Status

Recruiting

Address

Southeast University (SEU) - Zhongda Hospital

Nanjing, , 210009

Shanghai Pulmonary Hospital, Shanghai, China

Status

Recruiting

Address

Shanghai Pulmonary Hospital

Shanghai, , 200437

Tianjin, China

Status

Recruiting

Address

Tianjin Medical University General Hospital

Tianjin, , 300052

Vseobecna fakultni nemocnice v Praze, Praha, Czechia

Status

Recruiting

Address

Vseobecna fakultni nemocnice v Praze

Praha, , 128 21

Le Kremlin-Bicêtre, Cedex, France

Status

Recruiting

Address

Groupement Hospitalier Sud - Hôpital Bicêtre

Le Kremlin-Bicêtre, Cedex, 94275

Bron, France

Status

Recruiting

Address

Hôpital Cardio-Vasculaire et Pneumologique Louis Pradel

Bron, , 69677

Hôpital Nord - CHU Marseille, Marseille, France

Status

Recruiting

Address

Hôpital Nord - CHU Marseille

Marseille, , 94275

Hopital Arnaud de Villeneuve, Montpellier, France

Status

Recruiting

Address

Hopital Arnaud de Villeneuve

Montpellier, , 34295

Strasbourg, France

Status

Recruiting

Address

Les Hôpitaux Universitaires de Strasbourg

Strasbourg, , 67091

Dresden, Germany

Status

Recruiting

Address

Universitaetsklinikum Carl Gustav Carus TU Dresden

Dresden, , 1307

Giesen, Germany

Status

Recruiting

Address

Universitaetsklinikum Giessen und Marburg GmbH Standort Giessen

Giesen, , 35292

Universitaetsklinikum Heidelberg, Heidelberg, Germany

Status

Recruiting

Address

Universitaetsklinikum Heidelberg

Heidelberg, , 69126

München Klinik Bogenhausen, München, Germany

Status

Recruiting

Address

München Klinik Bogenhausen

München, , 81925

University General Hospital Attikon, Athens, Greece

Status

Recruiting

Address

University General Hospital Attikon

Athens, , 10676

Cardiosurgery Hospital, Kallithéa, Greece

Status

Recruiting

Address

Cardiosurgery Hospital

Kallithéa, , 17674

AHEPA General Hospital of Thessaloniki, Thessaloníki, Greece

Status

Recruiting

Address

AHEPA General Hospital of Thessaloniki

Thessaloníki, , 54637

The Lady Davis Carmel Medical Center, Haifa, Israel

Status

Recruiting

Address

The Lady Davis Carmel Medical Center

Haifa, , 34362

Hadassah University Hospital - Ein Kerem, Jerusalem, Israel

Status

Recruiting

Address

Hadassah University Hospital - Ein Kerem

Jerusalem, , 91999

Tel Aviv Sourasky Medical Center, Tel Aviv, Israel

Status

Recruiting

Address

Tel Aviv Sourasky Medical Center

Tel Aviv, , 64239

Foggia, Italy

Status

Recruiting

Address

Azienda Ospedaliero Universitaria Ospedali Riuniti - Foggia

Foggia, , 71122

Ospedale San Giuseppe - Fatebenefratelli, Milan, Italy

Status

Recruiting

Address

Ospedale San Giuseppe - Fatebenefratelli

Milan, , 20123

Monza, Italy

Status

Recruiting

Address

Azienda Socio Sanitaria Territoriale di Monza

Monza, , 20900

Azienda Ospedaliera Vincenzo Monaldi, Napoli, Italy

Status

Recruiting

Address

Azienda Ospedaliera Vincenzo Monaldi

Napoli, , 80131

Palermo, Italy

Status

Recruiting

Address

Istituto Mediterraneo per i Trapianti e Terapie ad Alta Specializzazione

Palermo, , 90127

Fondazione IRCCS Policlinico San Matteo, Pavia, Italy

Status

Recruiting

Address

Fondazione IRCCS Policlinico San Matteo

Pavia, , 27100

Rome, Italy

Status

Recruiting

Address

Azienda Ospedaliera Universitaria Policlinico Umberto I

Rome, , 137

Riga, Latvia

Status

Recruiting

Address

Pauls Stradins Clinical University Hospital

Riga, , 1002

CICUM San Miguel, Guadalajara, Jalisco, Mexico

Status

Recruiting

Address

CICUM San Miguel

Guadalajara, Jalisco, 44160

Monterrey, Nuevo León, Mexico

Status

Recruiting

Address

Unidad de Investigacion Clinica en Medicina S.C.

Monterrey, Nuevo León, 64718

Mexico City, Mexico

Status

Recruiting

Address

Instituto Nacional de Cardiologia Dr Ignacio Chavez Rivera

Mexico City, , 14080

Monterrey, Mexico

Status

Recruiting

Address

Universidad Autonoma de Nuevo Leon, Hospital Universitario

Monterrey, , 64460

Amsterdam UMC, Locatie VUMC, Amsterdam, Netherlands

Status

Recruiting

Address

Amsterdam UMC, Locatie VUMC

Amsterdam, , 1081 HV

Krakow, Poland

Status

Recruiting

Address

Krakowski Szpital Specjalistyczny im. Jana Pawla II

Krakow, , 31-202

Poznań, Poland

Status

Recruiting

Address

Szpital Kliniczny Przemienienia Pańskiego UM im. Marcinkowskiego

Poznań, , 61-848

Wrocław, Poland

Status

Recruiting

Address

Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego

Wrocław, , 50-556

Bieganski Provincial Specialist Hospital, Łódź, Poland

Status

Recruiting

Address

Bieganski Provincial Specialist Hospital

Łódź, , 91-347

Hospital Garcia de Orta, EPE, Almada, Portugal

Status

Recruiting

Address

Hospital Garcia de Orta, EPE

Almada, , 2805-267

Hospital Pulido Valente, Lisboa, Portugal

Status

Recruiting

Address

Hospital Pulido Valente

Lisboa, , 1649-035

CHUPorto, Porto, Portugal

Status

Recruiting

Address

CHUPorto

Porto, , 4099-001

Cardiopulmonary Research Center, Guaynabo, Puerto Rico

Status

Recruiting

Address

Cardiopulmonary Research Center

Guaynabo, , 00968

National University Hospital, Singapore, Singapore

Status

Recruiting

Address

National University Hospital

Singapore, , 119074

Tan Tock Seng Hospital, Singapore, Singapore

Status

Recruiting

Address

Tan Tock Seng Hospital

Singapore, , 308433

Center of Chest Disease Johannesburg, Johannesburg, South Africa

Status

Recruiting

Address

Center of Chest Disease Johannesburg

Johannesburg, , 2193

Hospital Universitari Vall d'Hebron, Barcelona, Spain

Status

Recruiting

Address

Hospital Universitari Vall d'Hebron

Barcelona, , 08035

Hospital Clinic de Barcelona, Barcelona, Spain

Status

Recruiting

Address

Hospital Clinic de Barcelona

Barcelona, , 8036

Las Palmas de Gran Canaria, Spain

Status

Recruiting

Address

Hosp. Universitario Gran Canaria Doctor Negrin

Las Palmas de Gran Canaria, , 35010

Hospital 12 de Octubre, Madrid, Spain

Status

Recruiting

Address

Hospital 12 de Octubre

Madrid, , 28014

Universidad Autonoma de Madrid, Madrid, Spain

Status

Recruiting

Address

Universidad Autonoma de Madrid

Madrid, , 28046

Málaga, Spain

Status

Recruiting

Address

Hospital Universitario Virgen de la Victoria

Málaga, , 29071

Hospital universtario de Salamanca, Salamanca, Spain

Status

Recruiting

Address

Hospital universtario de Salamanca

Salamanca, , 37007

Santander, Spain

Status

Recruiting

Address

Hosp. Universitario Marques de Valdecilla

Santander, , 39003

Hospital Universitario de Toledo, Toledo, Spain

Status

Recruiting

Address

Hospital Universitario de Toledo

Toledo, , 45007

Norrlands Universitetssjukhus, Umeå, Sweden

Status

Recruiting

Address

Norrlands Universitetssjukhus

Umeå, , 907 37

Imperial College Healthcare NHS Trust, London, England, United Kingdom

Status

Recruiting

Address

Imperial College Healthcare NHS Trust

London, England, W12 0HS

Golden Jubilee National Hospital, Glasgow, United Kingdom

Status

Recruiting

Address

Golden Jubilee National Hospital

Glasgow, , G81 4DY

Royal Brompton Hospital, London, United Kingdom

Status

Recruiting

Address

Royal Brompton Hospital

London, , SW3 6HP

Newcastle, United Kingdom

Status

Recruiting

Address

The Newcastle upon Tyne Hospitals NHS Foundation Trust

Newcastle, , NE7 7DN

For more information, please contact PHA at Research@PHAssociation.org and refer to the terms of service below.

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