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Trial record 1 of 1 for:    NCT05036135
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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 : May 16, 2022
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Pulmonary Arterial Hypertension Drug: AV-101 Drug: Placebo Phase 2 Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 462 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official 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)
Actual Study Start Date : December 2, 2021
Estimated Primary Completion Date : December 2024
Estimated Study Completion Date : January 2025


Arm Intervention/treatment
Experimental: Phase 2b low dose AV-101 Drug: AV-101
AV-101 (imatinib) administered via dry powder inhalation

Experimental: Phase 2b medium dose AV-101 Drug: AV-101
AV-101 (imatinib) administered via dry powder inhalation

Experimental: Phase 2b high dose AV-101 Drug: AV-101
AV-101 (imatinib) administered via dry powder inhalation

Placebo Comparator: Phase 2b Placebo Drug: Placebo
Placebo administered via dry powder inhalation

Experimental: Phase 3 dose AV-101 (Optimal dose selected in Phase 2b) Drug: AV-101
AV-101 (imatinib) administered via dry powder inhalation

Placebo Comparator: Phase 3 Placebo Drug: Placebo
Placebo administered via dry powder inhalation




Primary Outcome Measures :
  1. Phase 2b: Change from Baseline in Pulmonary Vascular Resistance (PVR) [ Time Frame: 24 weeks ]
  2. Phase 3: Change from Baseline in Six Minute Walk Distance (6MWD) [ Time Frame: 24 weeks ]

Secondary Outcome Measures :
  1. Phase 2b: Change from Baseline in N-terminal pro B-type natriuretic peptide (NT-proBNP) [ Time Frame: 24 weeks ]
  2. Phase 2b: Change from Baseline in Six Minute Walk Distance (6MWD) [ Time Frame: 24 weeks ]
  3. Phase 2b: Incidence of Clinical Worsening [ Time Frame: 24 weeks ]
  4. Phase 2b: Proportion of Subjects with Improvement in WHO Functional Class [ Time Frame: 24 weeks ]
  5. 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

  6. 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

  7. Phase 3: Change from Baseline in NT-proBNP [ Time Frame: 24 weeks ]
  8. Phase 3: Time to Clinical Worsening [ Time Frame: 24 weeks ]
  9. Phase 3: Proportion of Subjects with Improvement in WHO Functional Class [ Time Frame: 24 weeks ]
  10. 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

  11. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05036135


Contacts
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Contact: Toll Free Number (888) 373-8110 clinicaltrials@aerovatetx.com

Locations
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United States, Indiana
Indiana University Health Recruiting
Indianapolis, Indiana, United States, 46202
Principal Investigator: Roberto Machado, MD         
United States, Kansas
University of Kansas Medical Center Recruiting
Kansas City, Kansas, United States, 66160
Principal Investigator: Leslie A Spikes, MD         
Sponsors and Collaborators
Aerovate Therapeutics
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Responsible Party: Aerovate Therapeutics
ClinicalTrials.gov Identifier: NCT05036135    
Other Study ID Numbers: AV-101-002
First Posted: September 5, 2021    Key Record Dates
Last Update Posted: May 16, 2022
Last Verified: May 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Keywords provided by Aerovate Therapeutics:
Pulmonary Arterial Hypertension
Lungs
Pulmonary
PAH
AV-101
imatinib
IMPAHCT
Additional relevant MeSH terms:
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Pulmonary Arterial Hypertension
Familial Primary Pulmonary Hypertension
Hypertension
Vascular Diseases
Cardiovascular Diseases
Hypertension, Pulmonary
Lung Diseases
Respiratory Tract Diseases