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

About the study

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.

Who can take part

You may be eligible to participate in the study if you meet the following criteria:

INCLUSION CRITERIA

Key Inclusion Criteria

PAH belonging to one of the subgroups:

I/HPAH, PAH-CTD,
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),
HIV associated or
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.

EXCLUSION CRITERIA

Key Exclusion Criteria