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A Study of AV-101 (Dry Powder Inhaled Imatinib) in Patients With Pulmonary Arterial Hypertension (PAH) (IMPAHCT)

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ClinicalTrials.gov Identifier: NCT05036135
Recruitment Status : Recruiting
First Posted : September 5, 2021
Last Update Posted : February 17, 2023
Sponsor:
Information provided by (Responsible Party):
Aerovate Therapeutics

Tracking Information
First Submitted Date  ICMJE August 16, 2021
First Posted Date  ICMJE September 5, 2021
Last Update Posted Date February 17, 2023
Actual Study Start Date  ICMJE December 2, 2021
Estimated Primary Completion Date December 2024   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 30, 2021)
  • Phase 2b: Change from Baseline in Pulmonary Vascular Resistance (PVR) [ Time Frame: 24 weeks ]
  • Phase 3: Change from Baseline in Six Minute Walk Distance (6MWD) [ Time Frame: 24 weeks ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 30, 2021)
  • Phase 2b: Change from Baseline in N-terminal pro B-type natriuretic peptide (NT-proBNP) [ Time Frame: 24 weeks ]
  • Phase 2b: Change from Baseline in Six Minute Walk Distance (6MWD) [ Time Frame: 24 weeks ]
  • Phase 2b: Incidence of Clinical Worsening [ Time Frame: 24 weeks ]
  • Phase 2b: Proportion of Subjects with Improvement in WHO Functional Class [ Time Frame: 24 weeks ]
  • Phase 2b: Change from Baseline in Registry to Evaluate Early and Long-Term PAH Disease Management (REVEAL) Lite 2.0 Risk Score [ Time Frame: 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 Health-Related Quality of Life emPHasis-10 Questionnaire Score [ Time Frame: 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 [ Time Frame: 24 weeks ]
  • Phase 3: Time to Clinical Worsening [ Time Frame: 24 weeks ]
  • Phase 3: Proportion of Subjects with Improvement in WHO Functional Class [ Time Frame: 24 weeks ]
  • Phase 3: Change from Baseline in Registry to Evaluate Early and Long-Term PAH Disease Management (REVEAL) Lite 2.0 Risk Score [ Time Frame: 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 [ Time Frame: 24 weeks ]
    PAH-SYMPACT is a patient reported outcome instrument developed to assess PAH symptoms and impacts
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study of AV-101 (Dry Powder Inhaled Imatinib) in Patients With Pulmonary Arterial Hypertension (PAH)
Official Title  ICMJE 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)
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Pulmonary Arterial Hypertension
Intervention  ICMJE
  • Drug: AV-101
    AV-101 (imatinib) administered via dry powder inhalation
  • Drug: Placebo
    Placebo administered via dry powder inhalation
Study Arms  ICMJE
  • Experimental: Phase 2b low dose AV-101
    Intervention: Drug: AV-101
  • Experimental: Phase 2b medium dose AV-101
    Intervention: Drug: AV-101
  • Experimental: Phase 2b high dose AV-101
    Intervention: Drug: AV-101
  • Placebo Comparator: Phase 2b Placebo
    Intervention: Drug: Placebo
  • Experimental: Phase 3 dose AV-101 (Optimal dose selected in Phase 2b)
    Intervention: Drug: AV-101
  • Placebo Comparator: Phase 3 Placebo
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: August 30, 2021)		 462
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE January 2025
Estimated Primary Completion Date December 2024   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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 two 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 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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Toll Free Number (888) 373-8110 clinicaltrials@aerovatetx.com
Listed Location Countries  ICMJE Argentina,   Australia,   Belgium,   Canada,   Chile,   France,   Israel,   Italy,   Poland,   Puerto Rico,   Singapore,   South Africa,   Spain,   Sweden,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT05036135
Other Study ID Numbers  ICMJE AV-101-002
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Current Responsible Party Aerovate Therapeutics
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Aerovate Therapeutics
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Aerovate Therapeutics
Verification Date February 2023

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP