NCT05036135

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

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)

• Status: Terminated
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 202 (actual)
• Sponsor: Aerovate Therapeutics · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Pulmonary Arterial Hypertension

Interventions

Type	Name	Description
DRUG	AV-101	AV-101 (imatinib) administered via dry powder inhalation
DRUG	Placebo	Placebo administered via dry powder inhalation

Timeline

• Start date: 2021-12-02
• Primary completion: 2024-08-09
• Completion: 2024-08-09
• First posted: 2021-09-05
• Last updated: 2024-08-23

Locations

128 sites across 26 countries: United States, 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

Regulatory

• FDA-regulated drug study