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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05036135




Registration number
NCT05036135
Ethics application status
Date submitted
16/08/2021
Date registered
5/09/2021

Titles & IDs
Public title
A Study of AV-101 (Dry Powder Inhaled Imatinib) in Patients With Pulmonary Arterial Hypertension (PAH)
Scientific title
IMPAHCT: A Phase 2b/3, Randomized, Double-Blind, Placebo-Controlled, 24-Week Dose Ranging and Confirmatory Study to Evaluate the Safety and Efficacy of AV-101 in Patients With Pulmonary Arterial Hypertension (PAH)
Secondary ID [1] 0 0
AV-101-002
Universal Trial Number (UTN)
Trial acronym
IMPAHCT
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pulmonary Arterial Hypertension 0 0
Condition category
Condition code
Respiratory 0 0 0 0
Other respiratory disorders / diseases
Human Genetics and Inherited Disorders 0 0 0 0
Other human genetics and inherited disorders
Cardiovascular 0 0 0 0
Hypertension

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - AV-101
Treatment: Drugs - Placebo

Experimental: AV-101 10 mg -

Experimental: AV-101 35 mg -

Experimental: AV-101 70 mg -

Placebo comparator: Placebo -


Treatment: Drugs: AV-101
AV-101 (imatinib) administered via dry powder inhalation

Treatment: Drugs: Placebo
Placebo administered via dry powder inhalation
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Phase 2b: Change from Baseline in Pulmonary Vascular Resistance (PVR)
Timepoint [1] 0 0
24 weeks
Primary outcome [2] 0 0
Phase 3: Change from Baseline in Six Minute Walk Distance (6MWD)
Timepoint [2] 0 0
24 weeks
Secondary outcome [1] 0 0
Phase 2b: Change from Baseline in N-terminal pro B-type natriuretic peptide (NT-proBNP)
Timepoint [1] 0 0
24 weeks
Secondary outcome [2] 0 0
Phase 2b: Change from Baseline in Six Minute Walk Distance (6MWD)
Timepoint [2] 0 0
24 weeks
Secondary outcome [3] 0 0
Phase 2b: Time to Clinical Worsening
Timepoint [3] 0 0
24 weeks
Secondary outcome [4] 0 0
Phase 2b: Proportion of Subjects with Improvement in WHO Functional Class
Timepoint [4] 0 0
24 weeks
Secondary outcome [5] 0 0
Phase 2b: Change from Baseline in Registry to Evaluate Early and Long-Term PAH Disease Management (REVEAL) Lite 2.0 Risk Score
Timepoint [5] 0 0
24 weeks
Secondary outcome [6] 0 0
Phase 2b: Change from Baseline in Health-Related Quality of Life emPHasis-10 Questionnaire Score
Timepoint [6] 0 0
24 weeks
Secondary outcome [7] 0 0
Phase 3: Change from Baseline in NT-proBNP
Timepoint [7] 0 0
24 weeks
Secondary outcome [8] 0 0
Phase 3: Time to Clinical Worsening
Timepoint [8] 0 0
24 weeks
Secondary outcome [9] 0 0
Phase 3: Proportion of Subjects with Improvement in WHO Functional Class
Timepoint [9] 0 0
24 weeks
Secondary outcome [10] 0 0
Phase 3: Change from Baseline in Registry to Evaluate Early and Long-Term PAH Disease Management (REVEAL) Lite 2.0 Risk Score
Timepoint [10] 0 0
24 weeks
Secondary outcome [11] 0 0
Phase 3: Change from Baseline in Pulmonary Arterial Hypertension-Symptoms and Impact (PAH-SYMPACT) Questionnaire Score
Timepoint [11] 0 0
24 weeks

Eligibility
Key inclusion 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
Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
2/12/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
9/08/2024
Sample size
Target
Accrual to date
Final
202
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC
Recruitment hospital [1] 0 0
Royal Prince Alfred Hospital - Camperdown
Recruitment hospital [2] 0 0
Concord Repatriation General Hospital - Concord West
Recruitment hospital [3] 0 0
Nepean Hospital - Kingswood
Recruitment hospital [4] 0 0
Westmead Hospital - Westmead
Recruitment hospital [5] 0 0
Sunshine Coast University Hospital - Birtinya
Recruitment hospital [6] 0 0
The Prince Charles Hospital - Chermside
Recruitment hospital [7] 0 0
The Alfred Hospital - Melbourne
Recruitment hospital [8] 0 0
Royal Adelaide Hospital - Adelaide
Recruitment hospital [9] 0 0
Fiona Stanley Hospital - Murdoch
Recruitment postcode(s) [1] 0 0
2050 - Camperdown
Recruitment postcode(s) [2] 0 0
2138 - Concord West
Recruitment postcode(s) [3] 0 0
2747 - Kingswood
Recruitment postcode(s) [4] 0 0
2145 - Westmead
Recruitment postcode(s) [5] 0 0
4575 - Birtinya
Recruitment postcode(s) [6] 0 0
4032 - Chermside
Recruitment postcode(s) [7] 0 0
3004 - Melbourne
Recruitment postcode(s) [8] 0 0
5000 - Adelaide
Recruitment postcode(s) [9] 0 0
6150 - Murdoch
Recruitment outside Australia
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United States of America
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Arizona
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California
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Colorado
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District of Columbia
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Florida
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Georgia
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Indiana
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Iowa
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Kansas
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Massachusetts
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Michigan
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Minnesota
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Missouri
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Nebraska
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New Mexico
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New York
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North Carolina
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Ohio
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Oregon
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Pennsylvania
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Tennessee
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Texas
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Virginia
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Argentina
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Buenos Aires
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Caba
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Argentina
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Córdoba
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Argentina
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Santa Fe
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Austria
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Vienna
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Brussels
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Leuven
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São Paulo
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Chile
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Praha
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Germany
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Giesen
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Germany
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Heidelberg
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Monza
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Napoli
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Pavia
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Rome
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Riga
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Jalisco
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Mexico City
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Netherlands
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Krakow
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Poznan
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Wroclaw
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Lódz
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Portugal
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Almada
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Lisboa
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Portugal
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Porto
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Puerto Rico
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Guaynabo
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Singapore
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Singapore
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South Africa
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Johannesburg
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Barcelona
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Las Palmas de Gran Canaria
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Madrid
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Málaga
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Santander
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Toledo
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Sweden
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Umeå
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England
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Glasgow
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London
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United Kingdom
State/province [96] 0 0
Newcastle

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Aerovate Therapeutics
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Toll Free Number
Address 0 0
Country 0 0
Phone 0 0
(888) 373-8110
Fax 0 0
Email 0 0
clinicaltrials@aerovatetx.com
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT05036135