A follow-up clinical trial will evaluate the long-term safety and efficacy of the dry powder inhaled formulation of imatinib (AV-101) in patients with pulmonary arterial hypertension (PAH).
The IMPAHCT-FUL: Inhaled iMatinib Pulmonary Arterial Hypertension Clinical Trial – Follow Up Long Term Extension trial is expected to start November 2, 2022, and has not yet begun recruiting patients.
Investigators aim to recruit 462 participants to the interventional study who will receive low-, medium-, or high-dose AV-101 until the optimal dose has been selected in the 24-week, placebo-controlled parent trial (AV-101-002). All subjects who successfully complete the parent trial will be offered the opportunity to join the new trial.
Primary outcome measures of the study are safety and tolerability of AV-101, which will be assessed by incidence of adverse events. Additional outcome measures include time to clinical worsening and change from baseline in 6-minute walk distance (6MWD), N-terminal pro-brain natriuretic peptide (NT-proBNP), and right ventricular function.
Read more about PAH therapies
Clinical worsening events will be defined as deaths, hospitalization for worsening PAH, initiation of parenteral prostanoids, or a 15% or more decline from baseline in 6MWD accompanied with continued or worsening World Health Organization functional class III or IV symptoms.
6MWD and NT-proBNP will be assessed at baseline, weeks 4, 12, and 24, and every 12 weeks up to study completion. Right ventricular function will be measured by resting transthoracic echocardiography at baseline, week 24, and every 12 weeks up to study completion.
The trial is sponsored by Aerovate Therapeutics. The expected completion date is December 31, 2025.
AV-101 was shown to be well tolerated by healthy adult volunteers in the phase 1 trial.
Inhaled imatinib pulmonary arterial hypertension clinical trial – follow up long term extension (IMPAHCT-FUL) (IMPAHCT-FUL). ClinicalTrials.gov. September 28, 2022. Updated September 28, 2022. Accessed October 18, 2022.