A Study of AV-101 (Dry Powder Inhaled Imatinib) in Patients With Pulmonary Arterial Hypertension (PAH)
- Registration Number
- NCT05036135
- Lead Sponsor
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 202
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description AV-101 10 mg AV-101 - AV-101 35 mg AV-101 - Placebo Placebo - AV-101 70 mg AV-101 -
- Primary Outcome Measures
Name Time Method Phase 2b: Change from Baseline in Pulmonary Vascular Resistance (PVR) 24 weeks Phase 3: Change from Baseline in Six Minute Walk Distance (6MWD) 24 weeks
- Secondary Outcome Measures
Name Time Method Phase 2b: Change from Baseline in Six Minute Walk Distance (6MWD) 24 weeks Phase 2b: Time to Clinical Worsening 24 weeks Phase 2b: Change from Baseline in Registry to Evaluate Early and Long-Term PAH Disease Management (REVEAL) Lite 2.0 Risk Score 24 weeks REVEAL Lite 2.0 risk scores range from 1 to 14; a higher score represents higher risk
Phase 2b: Change from Baseline in N-terminal pro B-type natriuretic peptide (NT-proBNP) 24 weeks Phase 2b: Proportion of Subjects with Improvement in WHO Functional Class 24 weeks Phase 2b: Change from Baseline in Health-Related Quality of Life emPHasis-10 Questionnaire Score 24 weeks emPHasis-10 questionnaire scores range from 0 - 50; a higher score represents a higher symptom burden
Phase 3: Change from Baseline in NT-proBNP 24 weeks Phase 3: Time to Clinical Worsening 24 weeks Phase 3: Proportion of Subjects with Improvement in WHO Functional Class 24 weeks Phase 3: Change from Baseline in Registry to Evaluate Early and Long-Term PAH Disease Management (REVEAL) Lite 2.0 Risk Score 24 weeks REVEAL Lite 2.0 risk scores range from 1 to 14; a higher score represents higher risk
Phase 3: Change from Baseline in Pulmonary Arterial Hypertension-Symptoms and Impact (PAH-SYMPACT) Questionnaire Score 24 weeks PAH-SYMPACT is a patient reported outcome instrument developed to assess PAH symptoms and impacts
Related Research Topics
Explore scientific publications, clinical data analysis, treatment approaches, and expert-compiled information related to the mechanisms and outcomes of this trial. Click any topic for comprehensive research insights.
Trial Locations
- Locations (128)
Arizona Pulmonary Specialists, Ltd.
🇺🇸Phoenix, Arizona, United States
University of Arizona, Department of Medicine
🇺🇸Tucson, Arizona, United States
UCLA/David Geffen School of Medicine-Pulmonary and Criticial Care
🇺🇸Los Angeles, California, United States
Kaiser Permanente Los Angeles Medical Center
🇺🇸Los Angeles, California, United States
Cedars-Sinai Medical Center, Pulmonary & Critical Care
🇺🇸Los Angeles, California, United States
Dept of Veterans Affairs Greater Los Angeles Healthcare System
🇺🇸Los Angeles, California, United States
UC Davis Medical Center
🇺🇸Sacramento, California, United States
University of California
🇺🇸San Francisco, California, United States
LA Biomedical Research Institute Harbor
🇺🇸Torrance, California, United States
University of Colorado Denver
🇺🇸Aurora, Colorado, United States
Scroll for more (118 remaining)Arizona Pulmonary Specialists, Ltd.🇺🇸Phoenix, Arizona, United States