search
Back to results

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

Primary Purpose

Pulmonary Arterial Hypertension

Status
Recruiting
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
AV-101
Sponsored by
Aerovate Therapeutics
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pulmonary Arterial Hypertension focused on measuring Pulmonary Arterial Hypertension, Lungs, Pulmonary, PAH, AV-101, imatinib, IMPAHCT, IMPAHCT-FUL

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Key Inclusion Criteria:

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.

Key Exclusion Criteria:

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.

Sites / Locations

  • Arizona Pulmonary Specialist. LTD.Recruiting
  • Kaiser Permanente - Los Angeles Medical CenterRecruiting
  • GW Medical Faculty AssociatesRecruiting
  • Indiana University HealthRecruiting
  • Ohio State UniversityRecruiting
  • Vanderbilt University Medical Center
  • Insituto Medico DAMIC
  • Hospital Dr. Jose Maria CullenRecruiting
  • Sunshine Coast University HospitalRecruiting
  • The Prince Charles HospitalRecruiting
  • Cliniques Universitaires de Bruxelles Hopital ErasmeRecruiting
  • University of Alberta HospitalRecruiting
  • Jewish General HospitalRecruiting
  • Groupement Hospitalier Sud - Hôpital BicêtreRecruiting
  • Hadassah University Hospital - Ein KeremRecruiting
  • Azienda Ospedaliero Universitaria Ospedali Riuniti - FoggiaRecruiting
  • Istituto Mediterraneo per i Trapianti e Terapie ad Alta SpecializzazioneRecruiting
  • Fondazione IRCCS Policlinico San MatteoRecruiting
  • Azienda Ospedaliera Universitaria Policlinico Umberto IRecruiting
  • Krakowski Szpital Specjalistyczny im. Jana Pawla IIRecruiting
  • National University HospitalRecruiting
  • Tan Tock Seng HospitalRecruiting
  • Center of Chest Disease JohannesburgRecruiting
  • Hospital Universitari Vall d'HebronRecruiting
  • Hospital 12 de OctubreRecruiting
  • Imperial College Healthcare NHS TrustRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

low dose AV-101

medium dose AV-101

high dose AV-101

Arm Description

Outcomes

Primary Outcome Measures

Safety and tolerability of AV-101
as measured by Incidence of Adverse Events

Secondary Outcome Measures

Full Information

First Posted
September 15, 2022
Last Updated
October 13, 2023
Sponsor
Aerovate Therapeutics
search

1. Study Identification

Unique Protocol Identification Number
NCT05557942
Brief Title
Inhaled iMatinib Pulmonary Arterial Hypertension Clinical Trial - Follow Up Long Term Extension (IMPAHCT-FUL)
Acronym
IMPAHCT-FUL
Official Title
A Long-Term Extension, Multi-Center Safety Study of AV-101 in Subjects With Pulmonary Arterial Hypertension (PAH) Who Have Completed Study AV-101-002 (IMPAHCT-FUL)
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 2, 2022 (Actual)
Primary Completion Date
December 31, 2025 (Anticipated)
Study Completion Date
December 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Aerovate Therapeutics

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
IMPAHCT-FUL: Inhaled iMatinib Pulmonary Arterial Hypertension Clinical Trial - Follow Up Long Term Extension (LTE) Trial is a follow up study to establish the long-term safety of AV-101. The long-term effects of AV-101 on efficacy measures will also be assessed. Subjects who successfully complete the 24-week placebo-controlled parent trial (AV-101-002) will be offered the opportunity to continue into this LTE study. Subjects who enroll in the study will receive one of three active AV-101 doses until such time as the optimal dose has been selected in the parent study.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulmonary Arterial Hypertension
Keywords
Pulmonary Arterial Hypertension, Lungs, Pulmonary, PAH, AV-101, imatinib, IMPAHCT, IMPAHCT-FUL

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
462 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
low dose AV-101
Arm Type
Experimental
Arm Title
medium dose AV-101
Arm Type
Experimental
Arm Title
high dose AV-101
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
AV-101
Intervention Description
AV-101 (imatinib) administered via dry powder inhalation
Primary Outcome Measure Information:
Title
Safety and tolerability of AV-101
Description
as measured by Incidence of Adverse Events
Time Frame
Through Study completion, anticipated to be approximately 3 years
Other Pre-specified Outcome Measures:
Title
Change from baseline in the 6MWD
Time Frame
Baseline, weeks 4,12 and 24, and every 12 weeks up to study completion
Title
Change from baseline in NT-proBNP
Time Frame
Baseline, weeks 4,12 and 24, and every 12 weeks up to study completion
Title
Change from baseline in Right Ventricular (RV) function (e.g. TAPSE, RVFAC, RV/PA coupling, TRJV etc.) as measured by Resting Transthoracic Echocardiography
Time Frame
Baseline, week 24, and every 12 weeks up to study completion
Title
Time to Clinical Worsening
Description
Clinical Worsening Events will be defined as: Death (all causes) Hospitalization for worsening PAH Initiation of parenteral prostanoids (subcutaneous or intravenous infusion) ≥ 15% decline from baseline in 6MWD accompanied with continued or worsening to WHO FC III or IV symptoms. The decline in 6MWD must be confirmed with a repeat test on a different day within 2 weeks Time to clinical worsening is the number of days between the earliest occurrence of the clinical worsening component and the date of the first dose in the parent trial.
Time Frame
Through Study completion, anticipated to be approximately 3 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Key Inclusion Criteria: 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. Key Exclusion Criteria: 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Toll Free Number
Phone
(888) 373-8110
Email
clinicaltrials@aerovatetx.com
Facility Information:
Facility Name
Arizona Pulmonary Specialist. LTD.
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85012
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Naomi Habib, MD
Facility Name
Kaiser Permanente - Los Angeles Medical Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90027
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kenneth Wei, MD
Facility Name
GW Medical Faculty Associates
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20037
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mardi Gomberg-Maitland, MD
Facility Name
Indiana University Health
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Roberto Machado, MD
Facility Name
Ohio State University
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Veronica Franco, MD
Facility Name
Vanderbilt University Medical Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ivan Robbins, MD
Facility Name
Insituto Medico DAMIC
City
Córdoba
ZIP/Postal Code
5009
Country
Argentina
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Luis Guzman, MD
Facility Name
Hospital Dr. Jose Maria Cullen
City
Santa Fe
ZIP/Postal Code
S3000EOZ
Country
Argentina
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Cristian Edgardo Botta, MD
Facility Name
Sunshine Coast University Hospital
City
Birtinya
State/Province
Queensland
ZIP/Postal Code
4575
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
James Anderson, MD
Facility Name
The Prince Charles Hospital
City
Chermside
State/Province
Queensland
ZIP/Postal Code
4032
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
John Feenstra, MD
Facility Name
Cliniques Universitaires de Bruxelles Hopital Erasme
City
Bruxelles
ZIP/Postal Code
1070
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jean-Luc Vachiery, MD
Facility Name
University of Alberta Hospital
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 2B7
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Evangelos Michelakis, MD
Facility Name
Jewish General Hospital
City
Montréal
State/Province
Quebec
ZIP/Postal Code
H3T 1E2
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
David Langleben, MD
Facility Name
Groupement Hospitalier Sud - Hôpital Bicêtre
City
Le Kremlin-Bicêtre
ZIP/Postal Code
94275
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Olivier Sitbon, MD
Facility Name
Hadassah University Hospital - Ein Kerem
City
Jerusalem
ZIP/Postal Code
91999
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Neville Berkman, MD, FRCP
Facility Name
Azienda Ospedaliero Universitaria Ospedali Riuniti - Foggia
City
Foggia
ZIP/Postal Code
71122
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michele Correale, MD
Facility Name
Istituto Mediterraneo per i Trapianti e Terapie ad Alta Specializzazione
City
Palermo
ZIP/Postal Code
90127
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Patrizio Vitulo, MD
Facility Name
Fondazione IRCCS Policlinico San Matteo
City
Pavia
ZIP/Postal Code
27100
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Stefano Ghio, MD
Facility Name
Azienda Ospedaliera Universitaria Policlinico Umberto I
City
Rome
ZIP/Postal Code
137
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dario Vizza, MD
Facility Name
Krakowski Szpital Specjalistyczny im. Jana Pawla II
City
Kraków
ZIP/Postal Code
31-202
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Grzegorz Kopec, MD
Facility Name
National University Hospital
City
Singapore
ZIP/Postal Code
119074
Country
Singapore
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ting Ting Low, MD
Facility Name
Tan Tock Seng Hospital
City
Singapore
ZIP/Postal Code
308433
Country
Singapore
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kwang How Mok, MD
Facility Name
Center of Chest Disease Johannesburg
City
Johannesburg
ZIP/Postal Code
2193
Country
South Africa
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Paul Williams, MD
Facility Name
Hospital Universitari Vall d'Hebron
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Manuel Lopez Meseguer, MD, PhD
Facility Name
Hospital 12 de Octubre
City
Madrid
ZIP/Postal Code
28014
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pilar Escribano Subias, MD
Facility Name
Imperial College Healthcare NHS Trust
City
London
ZIP/Postal Code
W12 0HS
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Luke Howard, MD

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs