A Study of AV-101 (Dry Powder Inhaled Imatinib) in Patients With Pulmonary Arterial Hypertension (PAH)
- Registration Number
- NCT05036135
- Lead Sponsor
- Aerovate Therapeutics
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 202
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description AV-101 10 mg AV-101 - AV-101 35 mg AV-101 - Placebo Placebo - AV-101 70 mg AV-101 -
- Primary Outcome Measures
Name Time Method Phase 2b: Change from Baseline in Pulmonary Vascular Resistance (PVR) 24 weeks Phase 3: Change from Baseline in Six Minute Walk Distance (6MWD) 24 weeks
- Secondary Outcome Measures
Name Time Method Phase 2b: Change from Baseline in Six Minute Walk Distance (6MWD) 24 weeks Phase 2b: Time to Clinical Worsening 24 weeks Phase 2b: Change from Baseline in Registry to Evaluate Early and Long-Term PAH Disease Management (REVEAL) Lite 2.0 Risk Score 24 weeks REVEAL Lite 2.0 risk scores range from 1 to 14; a higher score represents higher risk
Phase 2b: Change from Baseline in N-terminal pro B-type natriuretic peptide (NT-proBNP) 24 weeks Phase 2b: Proportion of Subjects with Improvement in WHO Functional Class 24 weeks Phase 2b: Change from Baseline in Health-Related Quality of Life emPHasis-10 Questionnaire Score 24 weeks emPHasis-10 questionnaire scores range from 0 - 50; a higher score represents a higher symptom burden
Phase 3: Change from Baseline in NT-proBNP 24 weeks Phase 3: Time to Clinical Worsening 24 weeks Phase 3: Proportion of Subjects with Improvement in WHO Functional Class 24 weeks Phase 3: Change from Baseline in Registry to Evaluate Early and Long-Term PAH Disease Management (REVEAL) Lite 2.0 Risk Score 24 weeks REVEAL Lite 2.0 risk scores range from 1 to 14; a higher score represents higher risk
Phase 3: Change from Baseline in Pulmonary Arterial Hypertension-Symptoms and Impact (PAH-SYMPACT) Questionnaire Score 24 weeks PAH-SYMPACT is a patient reported outcome instrument developed to assess PAH symptoms and impacts
Trial Locations
- Locations (128)
Tufts Medical Center, Inc.
馃嚭馃嚫Boston, Massachusetts, United States
AHEPA General Hospital of Thessaloniki
馃嚞馃嚪Thessalon铆ki, Greece
University of Minnesota
馃嚭馃嚫Minneapolis, Minnesota, United States
Duke University Medical Center - Duke South Clinic
馃嚭馃嚫Durham, North Carolina, United States
Vanderbilt University Medical Center
馃嚭馃嚫Nashville, Tennessee, United States
UCLA/David Geffen School of Medicine-Pulmonary and Criticial Care
馃嚭馃嚫Los Angeles, California, United States
Arizona Pulmonary Specialists, Ltd.
馃嚭馃嚫Phoenix, Arizona, United States
Cedars-Sinai Medical Center, Pulmonary & Critical Care
馃嚭馃嚫Los Angeles, California, United States
Dept of Veterans Affairs Greater Los Angeles Healthcare System
馃嚭馃嚫Los Angeles, California, United States
University of California
馃嚭馃嚫San Francisco, California, United States
George Washington University Medical Faculty Associates, Inc.
馃嚭馃嚫Washington, District of Columbia, United States
Indiana University Health
馃嚭馃嚫Indianapolis, Indiana, United States
The Unviersity of New Mexico - UNM Hospitals
馃嚭馃嚫Albuquerque, New Mexico, United States
New York-Presbyterian Brooklyn Methodist Hospital
馃嚭馃嚫Brooklyn, New York, United States
The Lindner Center for Research and Education
馃嚭馃嚫Cincinnati, Ohio, United States
University of Cincinnati
馃嚭馃嚫Cincinnati, Ohio, United States
Stat Care Pulmonary Consultants, PLLC
馃嚭馃嚫Knoxville, Tennessee, United States
Sentara Medical Group - Sentara Pulmonary & Critical Care Specialists
馃嚭馃嚫Norfolk, Virginia, United States
Houston Methodist Hospital
馃嚭馃嚫Houston, Texas, United States
Hospital Britanico de Buenos Aires
馃嚘馃嚪Buenos Aires, Argentina
Hospital Dr. Jose Maria Cullen
馃嚘馃嚪Santa Fe, Argentina
Concord Repatriation General Hospital
馃嚘馃嚭Concord West, New South Wales, Australia
Nepean Hospital
馃嚘馃嚭Kingswood, New South Wales, Australia
Westmead Hospital
馃嚘馃嚭Westmead, New South Wales, Australia
Washington University School of Medicine
馃嚭馃嚫Saint Louis, Missouri, United States
Sunshine Coast University Hospital
馃嚘馃嚭Birtinya, Queensland, Australia
The Prince Charles Hospital
馃嚘馃嚭Chermside, Queensland, Australia
Fiona Stanley Hospital
馃嚘馃嚭Murdoch, Australia
The Alfred Hospital
馃嚘馃嚭Melbourne, Victoria, Australia
AKH - Medizinische Universitat Wien
馃嚘馃嚬Vienna, Austria
Hopital Erasme - Cliniques Universitaires de Bruxelles
馃嚙馃嚜Brussels, Belgium
The Governors of the University of Calgary
馃嚚馃嚘Calgary, Alberta, Canada
Santa Casa de Misericordia de Porto Alegre
馃嚙馃嚪Porto Alegre, Brazil
UZ Leuven
馃嚙馃嚜Leuven, Belgium
Heart Institute - University of Sao Paulo
馃嚙馃嚪S茫o Paulo, Brazil
London Health Science Centre
馃嚚馃嚘London, Ontario, Canada
Jewish General Hospital
馃嚚馃嚘Montr茅al, Quebec, Canada
Centro de Investigaciones Clinicas de la Universidad Catolica
馃嚚馃嚤Santiago, Chile
Peking Union Medical College Hospital
馃嚚馃嚦Beijing, China
Chongqing Medical University - The First Affiliated Hospital
馃嚚馃嚦Chongqing, China
Guangdong Provincial People's Hospital
馃嚚馃嚦Guangdong, China
Central South University - The Second Xiangya Hospital
馃嚚馃嚦Hunan, China
Yanan Hospital of Kunming City
馃嚚馃嚦Kunming, China
Gansu Provincial People's Hospital
馃嚚馃嚦Lanzhou, China
Tianjin Medical University General Hospital
馃嚚馃嚦Tianjin, China
Southeast University (SEU) - Zhongda Hospital
馃嚚馃嚦Nanjing, China
Shanghai Pulmonary Hospital
馃嚚馃嚦Shanghai, China
Vseobecna fakultni nemocnice v Praze
馃嚚馃嚳Praha, Czechia
Groupement Hospitalier Sud - H么pital Bic锚tre
馃嚝馃嚪Le Kremlin-Bic锚tre, Cedex, France
H么pital Cardio-Vasculaire et Pneumologique Louis Pradel
馃嚝馃嚪Bron, France
Universitaetsklinikum Carl Gustav Carus TU Dresden
馃嚛馃嚜Dresden, Germany
Hopital Arnaud de Villeneuve
馃嚝馃嚪Montpellier, France
H么pital Nord - CHU Marseille
馃嚝馃嚪Marseille, France
Les H么pitaux Universitaires de Strasbourg
馃嚝馃嚪Strasbourg, France
M眉nchen Klinik Bogenhausen
馃嚛馃嚜M眉nchen, Germany
University General Hospital Attikon
馃嚞馃嚪Athens, Greece
Cardiosurgery Hospital
馃嚞馃嚪Kallith茅a, Greece
Hadassah University Hospital - Ein Kerem
馃嚠馃嚤Jerusalem, Israel
Azienda Ospedaliero Universitaria Ospedali Riuniti - Foggia
馃嚠馃嚬Foggia, Italy
Ospedale San Giuseppe - Fatebenefratelli
馃嚠馃嚬Milan, Italy
Tel Aviv Sourasky Medical Center
馃嚠馃嚤Tel Aviv, Israel
Azienda Socio Sanitaria Territoriale di Monza
馃嚠馃嚬Monza, Italy
Azienda Ospedaliera Vincenzo Monaldi
馃嚠馃嚬Napoli, Italy
Fondazione IRCCS Policlinico San Matteo
馃嚠馃嚬Pavia, Italy
Azienda Ospedaliera Universitaria Policlinico Umberto I
馃嚠馃嚬Rome, Italy
Unidad de Investigacion Clinica en Medicina S.C.
馃嚥馃嚱Monterrey, Nuevo Le贸n, Mexico
Instituto Nacional de Cardiologia Dr Ignacio Chavez Rivera
馃嚥馃嚱Mexico City, Mexico
Universidad Autonoma de Nuevo Leon, Hospital Universitario
馃嚥馃嚱Monterrey, Mexico
Amsterdam UMC, Locatie VUMC
馃嚦馃嚤Amsterdam, Netherlands
Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego
馃嚨馃嚤Wroc艂aw, Poland
Krakowski Szpital Specjalistyczny im. Jana Pawla II
馃嚨馃嚤Krakow, Poland
Szpital Kliniczny Przemienienia Pa艅skiego UM im. Marcinkowskiego
馃嚨馃嚤Pozna艅, Poland
Hospital Pulido Valente
馃嚨馃嚬Lisboa, Portugal
Bieganski Provincial Specialist Hospital
馃嚨馃嚤艁贸d藕, Poland
Hospital Garcia de Orta, EPE
馃嚨馃嚬Almada, Portugal
Cardiopulmonary Research Center
馃嚨馃嚪Guaynabo, Puerto Rico
CHUPorto
馃嚨馃嚬Porto, Portugal
National University Hospital
馃嚫馃嚞Singapore, Singapore
Tan Tock Seng Hospital
馃嚫馃嚞Singapore, Singapore
Hospital Universitari Vall d'Hebron
馃嚜馃嚫Barcelona, Spain
Center of Chest Disease Johannesburg
馃嚳馃嚘Johannesburg, South Africa
Hosp. Universitario Gran Canaria Doctor Negrin
馃嚜馃嚫Las Palmas de Gran Canaria, Spain
Hospital Universitario de Toledo
馃嚜馃嚫Toledo, Spain
Hospital universtario de Salamanca
馃嚜馃嚫Salamanca, Spain
Hosp. Universitario Marques de Valdecilla
馃嚜馃嚫Santander, Spain
Norrlands Universitetssjukhus
馃嚫馃嚜Ume氓, Sweden
Golden Jubilee National Hospital
馃嚞馃嚙Glasgow, United Kingdom
The Newcastle upon Tyne Hospitals NHS Foundation Trust
馃嚞馃嚙Newcastle, United Kingdom
National Jewish Health
馃嚭馃嚫Denver, Colorado, United States
University of Nebraska Medical Center- Hematology/Oncology Section
馃嚭馃嚫Omaha, Nebraska, United States
Hospital Clinic de Barcelona
馃嚜馃嚫Barcelona, Spain
Hospital 12 de Octubre
馃嚜馃嚫Madrid, Spain
Universidad Autonoma de Madrid
馃嚜馃嚫Madrid, Spain
Hospital Universitario Virgen de la Victoria
馃嚜馃嚫M谩laga, Spain
Universitaetsklinikum Giessen und Marburg GmbH Standort Giessen
馃嚛馃嚜Giesen, Germany
Universitaetsklinikum Heidelberg
馃嚛馃嚜Heidelberg, Germany
The Lady Davis Carmel Medical Center
馃嚠馃嚤Haifa, Israel
Royal Prince Alfred Hospital
馃嚘馃嚭Camperdown, New South Wales, Australia
Cardiolog铆a Palermo
馃嚘馃嚪Caba, Argentina
Nexo Salud Investigaci贸n Cl铆nica
馃嚘馃嚪Buenos Aires, Argentina
Sanatorio de la Trinidad Mitre
馃嚘馃嚪Buenos Aires, Argentina
Insituto Medico DAMIC
馃嚘馃嚪C贸rdoba, Argentina
Hospital Italiano de Cordoba
馃嚘馃嚪C贸rdoba, Argentina
UC Davis Medical Center
馃嚭馃嚫Sacramento, California, United States
University of Colorado Denver
馃嚭馃嚫Aurora, Colorado, United States
Kaiser Permanente Los Angeles Medical Center
馃嚭馃嚫Los Angeles, California, United States
LA Biomedical Research Institute Harbor
馃嚭馃嚫Torrance, California, United States
Mayo Clinic Florida
馃嚭馃嚫Jacksonville, Florida, United States
Emory University
馃嚭馃嚫Atlanta, Georgia, United States
University of Iowa Hospitals & Clinics
馃嚭馃嚫Iowa City, Iowa, United States
NYU Langone Seaport
馃嚭馃嚫New York, New York, United States
The Ohio State University Wexner Medical Center
馃嚭馃嚫Columbus, Ohio, United States
Bend Memorial Clinic
馃嚭馃嚫Oregon City, Oregon, United States
Hospital of the University of Pennsylvania
馃嚭馃嚫Philadelphia, Pennsylvania, United States
UPMC Presbyterian Hospital
馃嚭馃嚫Pittsburgh, Pennsylvania, United States
Baylor University Medical Center
馃嚭馃嚫Dallas, Texas, United States
Royal Adelaide Hospital
馃嚘馃嚭Adelaide, Australia
Istituto Mediterraneo per i Trapianti e Terapie ad Alta Specializzazione
馃嚠馃嚬Palermo, Italy
Orlando Heart Center
馃嚭馃嚫Orlando, Florida, United States
University of Michigan
馃嚭馃嚫Ann Arbor, Michigan, United States
Pauls Stradins Clinical University Hospital
馃嚤馃嚮Riga, Latvia
CICUM San Miguel
馃嚥馃嚱Guadalajara, Jalisco, Mexico
Imperial College Healthcare NHS Trust
馃嚞馃嚙London, England, United Kingdom
University of Alberta Hospital
馃嚚馃嚘Edmonton, Alberta, Canada
University of Arizona, Department of Medicine
馃嚭馃嚫Tucson, Arizona, United States
Royal Brompton Hospital
馃嚞馃嚙London, United Kingdom
University of Kansas Medical Center
馃嚭馃嚫Kansas City, Kansas, United States
Thomas Jefferson University
馃嚭馃嚫Philadelphia, Pennsylvania, United States