Inhaled Imatinib for Pulmonary Arterial Hypertension (IMPAHCT Trial)

Recruiting in Palo Alto (17 mi)

+127 other locations

Age: 18+

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Phase 2 & 3

Waitlist Available

Sponsor: Aerovate Therapeutics

Prior Safety Data

Trial Summary

What is the purpose of this trial?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.

Eligibility Criteria

This trial is for people with Pulmonary Arterial Hypertension (PAH) who can walk at least 100 meters but not more than 475 meters. They should be on stable PAH medication and have WHO Functional Class II, III or IV symptoms. It's not for those with left-sided heart disease, other types of pulmonary hypertension, or women who are pregnant or breastfeeding.

Inclusion Criteria

My symptoms are moderate to very severe according to WHO standards.

I have been on two stable PAH treatments.

I can walk between 100 and 475 meters in 6 minutes.

Exclusion Criteria

My condition is classified as Group 2 to 5 pulmonary hypertension.

I have a history of heart disease affecting the left side of my heart.

Participant Groups

The IMPAHCT study is testing AV-101 (inhaled imatinib) to see if it helps patients with PAH. The first part will find the best dose by comparing three different amounts to a placebo. The second part measures how far patients can walk in six minutes after taking the drug for 24 weeks.

4Treatment groups

Experimental Treatment

Placebo Group

Group I: AV-101 70 mgExperimental Treatment1 Intervention

Group II: AV-101 35 mgExperimental Treatment1 Intervention

Group III: AV-101 10 mgExperimental Treatment1 Intervention

Group IV: PlaceboPlacebo Group1 Intervention