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	Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, China, Czechia, France, Germany, Greece, Israel, Italy, Latvia, Mexico, Netherlands, Poland, Portugal, Puerto Rico, Singapore, South Africa, Spain, Sweden, United Kingdom, 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

Site Contact

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