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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years - 75 Years
Gender All
More Inclusion & Exclusion 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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT05036135
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 2/Phase 3
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Aerovate Therapeutics
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

N/A
Principal Investigator Affiliation N/A
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry
Overall Status Recruiting
Countries Australia, Belgium, Spain, United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Pulmonary Arterial Hypertension
Arms & Interventions

Arms

Experimental: Phase 2b low dose AV-101

Experimental: Phase 2b medium dose AV-101

Experimental: Phase 2b high dose AV-101

Placebo Comparator: Phase 2b Placebo

Experimental: Phase 3 dose AV-101 (Optimal dose selected in Phase 2b)

Placebo Comparator: Phase 3 Placebo

Interventions

Drug: - AV-101

AV-101 (imatinib) administered via dry powder inhalation

Drug: - Placebo

Placebo administered via dry powder inhalation

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Arizona Pulmonary Specialists, Ltd., Phoenix, Arizona

Status

Recruiting

Address

Arizona Pulmonary Specialists, Ltd.

Phoenix, Arizona, 85012

Los Angeles, California

Status

Recruiting

Address

Kaiser Permanente Los Angeles Medical Center

Los Angeles, California, 90027

Los Angeles, California

Status

Recruiting

Address

Dept of Veterans Affairs Greater Los Angeles Healthcare System

Los Angeles, California, 90073

Georgetown University Hospital, Washington, District of Columbia

Status

Recruiting

Address

Georgetown University Hospital

Washington, District of Columbia, 20007

Washington, District of Columbia

Status

Recruiting

Address

George Washington University Medical Faculty Associates, Inc.

Washington, District of Columbia, 20073

Mayo Clinic Florida, Jacksonville, Florida

Status

Recruiting

Address

Mayo Clinic Florida

Jacksonville, Florida, 32224

Indiana University Health, Indianapolis, Indiana

Status

Recruiting

Address

Indiana University Health

Indianapolis, Indiana, 46202

University of Kansas Medical Center, Kansas City, Kansas

Status

Recruiting

Address

University of Kansas Medical Center

Kansas City, Kansas, 66160

Washington University School of Medicine, Saint Louis, Missouri

Status

Recruiting

Address

Washington University School of Medicine

Saint Louis, Missouri, 63110

Brooklyn, New York

Status

Recruiting

Address

New York-Presbyterian Brooklyn Methodist Hospital

Brooklyn, New York, 11215

Durham, North Carolina

Status

Recruiting

Address

Duke University Medical Center - Duke South Clinic

Durham, North Carolina, 27710

Columbus, Ohio

Status

Recruiting

Address

The Ohio State University Wexner Medical Center

Columbus, Ohio, 43210

Thomas Jefferson University, Philadelphia, Pennsylvania

Status

Recruiting

Address

Thomas Jefferson University

Philadelphia, Pennsylvania, 19107

International Sites

Sunshine Coast University Hospital, Birtinya, Queensland, Australia

Status

Recruiting

Address

Sunshine Coast University Hospital

Birtinya, Queensland, 4575

Brussels, Belgium

Status

Recruiting

Address

Hopital Erasme - Cliniques Universitaires de Bruxelles

Brussels, , 1070

Hospital 12 de Octubre, Madrid, Spain

Status

Recruiting

Address

Hospital 12 de Octubre

Madrid, , 28014

For more information, please contact PHA at Research@PHAssociation.org and refer to the terms of service below.

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