Inhaled Imatinib Pulmonary Arterial Hypertension Clinical Trial - Follow Up Long Term Extension (IMPAHCT-FUL)

NCT05557942 | Terminated Phase 3 Results DMC FDA Drug

• 1 other identifier: AV-101-003
• Study Type: interventional
• Target: 186
• Locations: 20 countries
• Sites: 72

Brief Summary

IMPAHCT-FUL: Inhaled Imatinib Pulmonary Arterial Hypertension Clinical Trial - Follow Up Long Term Extension (LTE) Trial was a follow up study to establish the long-term safety of AV-101. Subjects who successfully completed the 24-week placebo-controlled parent trial (AV-101-002, NCT#05036135) were offered the opportunity to continue into this LTE study. Subjects who enrolled in the study were to receive one of three active AV-101 doses until such time as the optimal dose was selected in the parent study.

Conditions

Pulmonary Arterial Hypertension

Keywords

Pulmonary Arterial Hypertension; Lungs; Pulmonary; PAH; AV-101; imatinib; IMPAHCT; IMPAHCT-FUL

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Treatment-emergent Adverse Events

  An Adverse Event (AE) was defined as any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Serious Adverse Events (SAEs) were defined as death, a life-threatening AE, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, or an important medical event that jeopardized participant and required medical intervention to prevent 1 of the outcomes listed in this definition. A summary of other non-serious AEs and all serious AEs, regardless of causality is located in Reported AE section.

  From date of first dose to 30 days after date of last dose (up to approximately 21 months)

Study Arms (6)

Placebo Crossover AV-101 10 mg

EXPERIMENTAL

Participants who previously received placebo in AV-101-002 received AV-101 (imatinib) 10 milligrams (mg) administered twice daily (BID) via dry powder inhalation.

Drug: AV-101

Placebo Crossover AV-101 35 mg

EXPERIMENTAL

Participants who previously received placebo in AV-101-002 received AV-101 (imatinib) 35 mg administered BID via dry powder inhalation.

Drug: AV-101

Placebo Crossover AV-101 70 mg

EXPERIMENTAL

Participants who previously received placebo in AV-101-002 received AV-101 (imatinib) 70 mg administered BID via dry powder inhalation.

Drug: AV-101

Continuing AV-101 10 mg

EXPERIMENTAL

Participants who previously received AV-101 10 mg in AV-101-002 received AV-101 (imatinib) 10 mg administered BID via dry powder inhalation.

Drug: AV-101

Continuing AV-101 35 mg

EXPERIMENTAL

Participants who previously received AV-101 35 mg in AV-101-002 received AV-101 (imatinib) 35 mg administered BID via dry powder inhalation.

Drug: AV-101

Continuing AV-101 70 mg

EXPERIMENTAL

Participants who previously received AV-101 70 mg in AV-101-002 received AV-101 (imatinib) 70 mg administered BID via dry powder inhalation.

Drug: AV-101

Interventions

AV-101 DRUG

AV-101 (imatinib) administered via dry powder inhalation

Continuing AV-101 10 mg; Continuing AV-101 35 mg; Continuing AV-101 70 mg; Placebo Crossover AV-101 10 mg; Placebo Crossover AV-101 35 mg; Placebo Crossover AV-101 70 mg

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• To be eligible, a participant is required to be or have:
• Consented to participate in the LTE and has successfully completed the placebo-controlled 24-week Study AV-101-002.

You may not qualify if:

• Subjects meeting any of the following criteria:
• The Investigator believes that it would not be in the best interest of the subject to be included in the LTE e.g., for clinical or social reasons.
• Subjects who were not compliant with study medication in AV-101-002 as assessed by the Investigator.

Sponsors & Collaborators

• Aerovate Therapeutics: lead

Study Sites (72)

Arizona Pulmonary Specialist. LTD.

Phoenix, Arizona, 85012, United States

Location

University of Arizona, Department of Medicine

Tucson, Arizona, 85724, United States

Location

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

Los Angeles, California, 90024, United States

Location

Kaiser Permanente - Los Angeles Medical Center

Los Angeles, California, 90027, United States

Location

UC Davis Medical Center

Sacramento, California, 95817, United States

Location

University of California

San Francisco, California, 94143, United States

Location

GW Medical Faculty Associates

Washington D.C., District of Columbia, 20037, United States

Location

Mayo Clinic Florida

Jacksonville, Florida, 32224, United States

Location

Emory University

Atlanta, Georgia, 30322, United States

Location

Indiana University Health

Indianapolis, Indiana, 46202, United States

Location

Tufts Medical Center, Inc.

Boston, Massachusetts, 02111, United States

Location

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

Ohio State University

Columbus, Ohio, 43210, United States

Location

UPMC Presbyterian Hospital

Pittsburgh, Pennsylvania, 15213, United States

Location

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

Location

Cardiologia Palmero

Buenos Aires, 1425, Argentina

Location

Nexo Salud Investigación Clínica

Buenos Aires, 1425, Argentina

Location

Sanatorio de la Trinidad Mitre

Buenos Aires, C1039AAO, Argentina

Location

Insituto Medico DAMIC

Córdoba, 5009, Argentina

Location

Hospital Dr. Jose Maria Cullen

Santa Fe, S3000EOZ, Argentina

Location

Royal Prince Alfred Hospital

Camperdown, New South Wales, 2050, Australia

Location

Sunshine Coast University Hospital

Birtinya, Queensland, 4575, Australia

Location

The Prince Charles Hospital

Chermside, Queensland, 4032, Australia

Location

The Alfred Hospital

Melbourne, Victoria, 3004, Australia

Location

Cliniques Universitaires de Bruxelles Hopital Erasme

Brussels, 1070, Belgium

Location

UZ Leuven

Leuven, 3000, Belgium

Location

University of Alberta Hospital

Edmonton, Alberta, T6G 2B7, Canada

Location

London Health Science Centre

London, Ontario, N6A 5W9, Canada

Location

Jewish General Hospital

Montreal, Quebec, H3T 1E2, Canada

Location

Centro de Investigaciones Clinicas de la Universidad Catolica

Santiago, 8330024, Chile

Location

Peking Union Medical College Hospital

Beijing, 100730, China

Location

Chongqing Medical University - The First Affiliated Hospital

Chongqing, 40016, China

Location

Guangdong Provincial People's Hospital

Guangdong, 510000, China

Location

Central South University - The Second Xiangya Hospital

Hunan, 410011, China

Location

Yanan Hospital of Kunming City

Kunming, 650051, China

Location

Gansu Provincial People's Hospital

Lanzhou, 730000, China

Location

Southeast University (SEU) - Zhongda Hospital

Nanjing, 210009, China

Location

Tianjin Medical University General Hospital

Tianjin, 300052, China

Location

Instituto Neumológico del Oriente S.A.

Floridablanca, 20-97, Colombia

Location

Groupement Hospitalier Sud - Hôpital Bicêtre

Le Kremlin-Bicêtre, 94275, France

Location

Hopital Arnaud de Villeneuve

Montpellier, 34295, France

Location

Les Hôpitaux Universitaires de Strasbourg

Strasbourg, 67091, France

Location

Universitaetsklinikum Carl Gustav Carus TU Dresden

Dresden, 1307, Germany

Location

Universitaetsklinikum Giessen und Marburg GmbH Standort Giessen

Giessen, 35392, Germany

Location

Universitaetsklinikum Heidelberg

Heidelberg, 69126, Germany

Location

Hadassah University Hospital - Ein Kerem

Jerusalem, 91999, Israel

Location

Azienda Ospedaliero Universitaria Ospedali Riuniti - Foggia

Foggia, 71122, Italy

Location

Ospedale San Giuseppe - Fatebenefratelli

Milan, 20123, Italy

Location

Fondazione IRCCS San Gerardo Dei Tintori

Monza, 20900, Italy

Location

Istituto Mediterraneo per i Trapianti e Terapie ad Alta Specializzazione

Palermo, 90127, Italy

Location

Fondazione IRCCS Policlinico San Matteo

Pavia, 27100, Italy

Location

Azienda Ospedaliera Universitaria Policlinico Umberto I

Rome, 137, Italy

Location

Pauls Stradins Clinical University Hospital

Riga, 1002, Latvia

Location

CICUM San Miguel

Guadalajara, Jalisco, 44160, Mexico

Location

Unidad de Investigacion Clinica en Medicina S.C.

Monterrey, Nuevo León, 64718, Mexico

Location

Krakowski Szpital Specjalistyczny im. Jana Pawla II

Krakow, 31-202, Poland

Location

Wojewódzki Specjalistyczny Szpital im. Dr. Wł. Biegańskiego w Łodzi

Lodz, 91-347, Poland

Location

Szpital Kliniczny Przemienienia Pańskiego UM im. Marcinkowskiego

Poznan, 61-848, Poland

Location

Hospital Garcia de Orta, EPE

Almada, 2805-267, Portugal

Location

Hospital Pulido Valente

Lisbon, 1769-001, Portugal

Location

National University Hospital

Singapore, 119074, Singapore

Location

Tan Tock Seng Hospital

Singapore, 308433, Singapore

Location

Center of Chest Disease Johannesburg

Johannesburg, 2193, South Africa

Location

Hospital Universitari Vall d'Hebron

Barcelona, 08035, Spain

Location

Hosp. Universitario Gran Canaria Doctor Negrin

Las Palmas de Gran Canaria, 35010, Spain

Location

Hospital 12 de Octubre

Madrid, 28014, Spain

Location

Hospital Universitario Virgen de la Victoria

Málaga, 29071, Spain

Location

Hospital universtario de Salamanca

Salamanca, 37007, Spain

Location

Hosp. Universitario Marques de Valdecilla

Santander, 39003, Spain

Location

Hospital Universitario de Toledo

Toledo, 45007, Spain

Location

Imperial College Healthcare NHS Trust

London, W12 0HS, United Kingdom

Location

MeSH Terms

Conditions

Pulmonary Arterial Hypertension

Condition Hierarchy (Ancestors)

Hypertension, Pulmonary; Lung Diseases; Respiratory Tract Diseases

Results Point of Contact

• Title: Toll Free Number
• Organization: Aerovate Therapeutics

clinicaltrials@aerovatetx.com

(888) 373-8110

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 15, 2022
• First Posted: September 28, 2022
• Study Start: November 2, 2022
• Primary Completion: August 8, 2024
• Study Completion: August 8, 2024
• Last Updated: October 10, 2024
• Results First Posted: October 10, 2024

Record last verified: 2024-10

Locations

GB (1); US (16); ZA (1); BE (2); IL (1); PL (3); PT (2); SG (2); ES (7); DE (3); LA (1); AU (4); CL (1); AR (5); ME (2); CA (3); CN (8); CO (1); FR (3); IT (6)