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.
๐บ๐ธBoston, Massachusetts, United States
AHEPA General Hospital of Thessaloniki
๐ฌ๐ทThessalonรญki, Greece
University of Minnesota
๐บ๐ธMinneapolis, Minnesota, United States
Duke University Medical Center - Duke South Clinic
๐บ๐ธDurham, North Carolina, United States
Vanderbilt University Medical Center
๐บ๐ธNashville, Tennessee, United States
UCLA/David Geffen School of Medicine-Pulmonary and Criticial Care
๐บ๐ธLos Angeles, California, United States
Arizona Pulmonary Specialists, Ltd.
๐บ๐ธPhoenix, Arizona, United States
Cedars-Sinai Medical Center, Pulmonary & Critical Care
๐บ๐ธLos Angeles, California, United States
Dept of Veterans Affairs Greater Los Angeles Healthcare System
๐บ๐ธLos Angeles, California, United States
University of California
๐บ๐ธSan Francisco, California, United States
George Washington University Medical Faculty Associates, Inc.
๐บ๐ธWashington, District of Columbia, United States
Indiana University Health
๐บ๐ธIndianapolis, Indiana, United States
The Unviersity of New Mexico - UNM Hospitals
๐บ๐ธAlbuquerque, New Mexico, United States
New York-Presbyterian Brooklyn Methodist Hospital
๐บ๐ธBrooklyn, New York, United States
The Lindner Center for Research and Education
๐บ๐ธCincinnati, Ohio, United States
University of Cincinnati
๐บ๐ธCincinnati, Ohio, United States
Stat Care Pulmonary Consultants, PLLC
๐บ๐ธKnoxville, Tennessee, United States
Sentara Medical Group - Sentara Pulmonary & Critical Care Specialists
๐บ๐ธNorfolk, Virginia, United States
Houston Methodist Hospital
๐บ๐ธHouston, Texas, United States
Hospital Britanico de Buenos Aires
๐ฆ๐ทBuenos Aires, Argentina
Hospital Dr. Jose Maria Cullen
๐ฆ๐ทSanta Fe, Argentina
Concord Repatriation General Hospital
๐ฆ๐บConcord West, New South Wales, Australia
Nepean Hospital
๐ฆ๐บKingswood, New South Wales, Australia
Westmead Hospital
๐ฆ๐บWestmead, New South Wales, Australia
Washington University School of Medicine
๐บ๐ธSaint Louis, Missouri, United States
Sunshine Coast University Hospital
๐ฆ๐บBirtinya, Queensland, Australia
The Prince Charles Hospital
๐ฆ๐บChermside, Queensland, Australia
Fiona Stanley Hospital
๐ฆ๐บMurdoch, Australia
The Alfred Hospital
๐ฆ๐บMelbourne, Victoria, Australia
AKH - Medizinische Universitat Wien
๐ฆ๐นVienna, Austria
Hopital Erasme - Cliniques Universitaires de Bruxelles
๐ง๐ชBrussels, Belgium
The Governors of the University of Calgary
๐จ๐ฆCalgary, Alberta, Canada
Santa Casa de Misericordia de Porto Alegre
๐ง๐ทPorto Alegre, Brazil
UZ Leuven
๐ง๐ชLeuven, Belgium
Heart Institute - University of Sao Paulo
๐ง๐ทSรฃo Paulo, Brazil
London Health Science Centre
๐จ๐ฆLondon, Ontario, Canada
Jewish General Hospital
๐จ๐ฆMontrรฉal, Quebec, Canada
Centro de Investigaciones Clinicas de la Universidad Catolica
๐จ๐ฑSantiago, Chile
Peking Union Medical College Hospital
๐จ๐ณBeijing, China
Chongqing Medical University - The First Affiliated Hospital
๐จ๐ณChongqing, China
Guangdong Provincial People's Hospital
๐จ๐ณGuangdong, China
Central South University - The Second Xiangya Hospital
๐จ๐ณHunan, China
Yanan Hospital of Kunming City
๐จ๐ณKunming, China
Gansu Provincial People's Hospital
๐จ๐ณLanzhou, China
Tianjin Medical University General Hospital
๐จ๐ณTianjin, China
Southeast University (SEU) - Zhongda Hospital
๐จ๐ณNanjing, China
Shanghai Pulmonary Hospital
๐จ๐ณShanghai, China
Vseobecna fakultni nemocnice v Praze
๐จ๐ฟPraha, Czechia
Groupement Hospitalier Sud - Hรดpital Bicรชtre
๐ซ๐ทLe Kremlin-Bicรชtre, Cedex, France
Hรดpital Cardio-Vasculaire et Pneumologique Louis Pradel
๐ซ๐ทBron, France
Universitaetsklinikum Carl Gustav Carus TU Dresden
๐ฉ๐ชDresden, Germany
Hopital Arnaud de Villeneuve
๐ซ๐ทMontpellier, France
Hรดpital Nord - CHU Marseille
๐ซ๐ทMarseille, France
Les Hรดpitaux Universitaires de Strasbourg
๐ซ๐ทStrasbourg, France
Mรผnchen Klinik Bogenhausen
๐ฉ๐ชMรผnchen, Germany
University General Hospital Attikon
๐ฌ๐ทAthens, Greece
Cardiosurgery Hospital
๐ฌ๐ทKallithรฉa, Greece
Hadassah University Hospital - Ein Kerem
๐ฎ๐ฑJerusalem, Israel
Azienda Ospedaliero Universitaria Ospedali Riuniti - Foggia
๐ฎ๐นFoggia, Italy
Ospedale San Giuseppe - Fatebenefratelli
๐ฎ๐นMilan, Italy
Tel Aviv Sourasky Medical Center
๐ฎ๐ฑTel Aviv, Israel
Azienda Socio Sanitaria Territoriale di Monza
๐ฎ๐นMonza, Italy
Azienda Ospedaliera Vincenzo Monaldi
๐ฎ๐นNapoli, Italy
Fondazione IRCCS Policlinico San Matteo
๐ฎ๐นPavia, Italy
Azienda Ospedaliera Universitaria Policlinico Umberto I
๐ฎ๐นRome, Italy
Unidad de Investigacion Clinica en Medicina S.C.
๐ฒ๐ฝMonterrey, Nuevo Leรณn, Mexico
Instituto Nacional de Cardiologia Dr Ignacio Chavez Rivera
๐ฒ๐ฝMexico City, Mexico
Universidad Autonoma de Nuevo Leon, Hospital Universitario
๐ฒ๐ฝMonterrey, Mexico
Amsterdam UMC, Locatie VUMC
๐ณ๐ฑAmsterdam, Netherlands
Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego
๐ต๐ฑWrocลaw, Poland
Krakowski Szpital Specjalistyczny im. Jana Pawla II
๐ต๐ฑKrakow, Poland
Szpital Kliniczny Przemienienia Paลskiego UM im. Marcinkowskiego
๐ต๐ฑPoznaล, Poland
Hospital Pulido Valente
๐ต๐นLisboa, Portugal
Bieganski Provincial Specialist Hospital
๐ต๐ฑลรณdลบ, Poland
Hospital Garcia de Orta, EPE
๐ต๐นAlmada, Portugal
Cardiopulmonary Research Center
๐ต๐ทGuaynabo, Puerto Rico
CHUPorto
๐ต๐นPorto, Portugal
National University Hospital
๐ธ๐ฌSingapore, Singapore
Tan Tock Seng Hospital
๐ธ๐ฌSingapore, Singapore
Hospital Universitari Vall d'Hebron
๐ช๐ธBarcelona, Spain
Center of Chest Disease Johannesburg
๐ฟ๐ฆJohannesburg, South Africa
Hosp. Universitario Gran Canaria Doctor Negrin
๐ช๐ธLas Palmas de Gran Canaria, Spain
Hospital Universitario de Toledo
๐ช๐ธToledo, Spain
Hospital universtario de Salamanca
๐ช๐ธSalamanca, Spain
Hosp. Universitario Marques de Valdecilla
๐ช๐ธSantander, Spain
Norrlands Universitetssjukhus
๐ธ๐ชUmeรฅ, Sweden
Golden Jubilee National Hospital
๐ฌ๐งGlasgow, United Kingdom
The Newcastle upon Tyne Hospitals NHS Foundation Trust
๐ฌ๐งNewcastle, United Kingdom
National Jewish Health
๐บ๐ธDenver, Colorado, United States
University of Nebraska Medical Center- Hematology/Oncology Section
๐บ๐ธOmaha, Nebraska, United States
Hospital Clinic de Barcelona
๐ช๐ธBarcelona, Spain
Hospital 12 de Octubre
๐ช๐ธMadrid, Spain
Universidad Autonoma de Madrid
๐ช๐ธMadrid, Spain
Hospital Universitario Virgen de la Victoria
๐ช๐ธMรกlaga, Spain
Universitaetsklinikum Giessen und Marburg GmbH Standort Giessen
๐ฉ๐ชGiesen, Germany
Universitaetsklinikum Heidelberg
๐ฉ๐ชHeidelberg, Germany
The Lady Davis Carmel Medical Center
๐ฎ๐ฑHaifa, Israel
Royal Prince Alfred Hospital
๐ฆ๐บCamperdown, New South Wales, Australia
Cardiologรญa Palermo
๐ฆ๐ทCaba, Argentina
Nexo Salud Investigaciรณn Clรญnica
๐ฆ๐ทBuenos Aires, Argentina
Sanatorio de la Trinidad Mitre
๐ฆ๐ทBuenos Aires, Argentina
Insituto Medico DAMIC
๐ฆ๐ทCรณrdoba, Argentina
Hospital Italiano de Cordoba
๐ฆ๐ทCรณrdoba, Argentina
UC Davis Medical Center
๐บ๐ธSacramento, California, United States
University of Colorado Denver
๐บ๐ธAurora, Colorado, United States
Kaiser Permanente Los Angeles Medical Center
๐บ๐ธLos Angeles, California, United States
LA Biomedical Research Institute Harbor
๐บ๐ธTorrance, California, United States
Mayo Clinic Florida
๐บ๐ธJacksonville, Florida, United States
Emory University
๐บ๐ธAtlanta, Georgia, United States
University of Iowa Hospitals & Clinics
๐บ๐ธIowa City, Iowa, United States
NYU Langone Seaport
๐บ๐ธNew York, New York, United States
The Ohio State University Wexner Medical Center
๐บ๐ธColumbus, Ohio, United States
Bend Memorial Clinic
๐บ๐ธOregon City, Oregon, United States
Hospital of the University of Pennsylvania
๐บ๐ธPhiladelphia, Pennsylvania, United States
UPMC Presbyterian Hospital
๐บ๐ธPittsburgh, Pennsylvania, United States
Baylor University Medical Center
๐บ๐ธDallas, Texas, United States
Royal Adelaide Hospital
๐ฆ๐บAdelaide, Australia
Istituto Mediterraneo per i Trapianti e Terapie ad Alta Specializzazione
๐ฎ๐นPalermo, Italy
Orlando Heart Center
๐บ๐ธOrlando, Florida, United States
University of Michigan
๐บ๐ธAnn Arbor, Michigan, United States
Pauls Stradins Clinical University Hospital
๐ฑ๐ปRiga, Latvia
CICUM San Miguel
๐ฒ๐ฝGuadalajara, Jalisco, Mexico
Imperial College Healthcare NHS Trust
๐ฌ๐งLondon, England, United Kingdom
University of Alberta Hospital
๐จ๐ฆEdmonton, Alberta, Canada
University of Arizona, Department of Medicine
๐บ๐ธTucson, Arizona, United States
Royal Brompton Hospital
๐ฌ๐งLondon, United Kingdom
University of Kansas Medical Center
๐บ๐ธKansas City, Kansas, United States
Thomas Jefferson University
๐บ๐ธPhiladelphia, Pennsylvania, United States