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Tyrosine Kinase Inhibitor

Inhaled Imatinib for Pulmonary Arterial Hypertension (IMPAHCT Trial)

Phase 2 & 3
Recruiting
Research Sponsored by Aerovate Therapeutics
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
World Health Organization (WHO) Functional Class II, III or IV symptoms
Stable concomitant background therapy of at least two PAH approved medications
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 weeks
Awards & highlights

IMPAHCT Trial Summary

This trial is testing a new way to give a drug to people with PAH, and is measuring how well it works compared to a placebo.

Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
While specific side effects of AV-101 aren't listed here, similar drugs often cause respiratory issues like coughing or wheezing, digestive problems, headaches, fatigue and sometimes dizziness or swelling.

IMPAHCT Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My symptoms are moderate to very severe according to WHO standards.
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I have been on two stable PAH treatments.
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I can walk between 100 and 475 meters in 6 minutes.

IMPAHCT Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Phase 2b: Change from Baseline in Pulmonary Vascular Resistance (PVR)
Phase 3: Change from Baseline in Six Minute Walk Distance (6MWD)
Secondary outcome measures
Phase 2b: Change from Baseline in Health-Related Quality of Life emPHasis-10 Questionnaire Score
Phase 2b: Change from Baseline in N-terminal pro B-type natriuretic peptide (NT-proBNP)
Phase 2b: Change from Baseline in Registry to Evaluate Early and Long-Term PAH Disease Management (REVEAL) Lite 2.0 Risk Score
+8 more

IMPAHCT Trial Design

6Treatment groups
Experimental Treatment
Placebo Group
Group I: Phase 3 dose AV-101 (Optimal dose selected in Phase 2b)Experimental Treatment1 Intervention
Group II: Phase 2b medium dose AV-101Experimental Treatment1 Intervention
Group III: Phase 2b low dose AV-101Experimental Treatment1 Intervention
Group IV: Phase 2b high dose AV-101Experimental Treatment1 Intervention
Group V: Phase 2b PlaceboPlacebo Group1 Intervention
Group VI: Phase 3 PlaceboPlacebo Group1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
AV-101
2018
Completed Phase 2
~230

Find a Location

Who is running the clinical trial?

Aerovate TherapeuticsLead Sponsor
1 Previous Clinical Trials
462 Total Patients Enrolled
1 Trials studying Pulmonary Arterial Hypertension
462 Patients Enrolled for Pulmonary Arterial Hypertension

Media Library

AV-101 (Tyrosine Kinase Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT05036135 — Phase 2 & 3
Pulmonary Arterial Hypertension Research Study Groups: Phase 3 dose AV-101 (Optimal dose selected in Phase 2b), Phase 2b low dose AV-101, Phase 2b medium dose AV-101, Phase 2b high dose AV-101, Phase 2b Placebo, Phase 3 Placebo
Pulmonary Arterial Hypertension Clinical Trial 2023: AV-101 Highlights & Side Effects. Trial Name: NCT05036135 — Phase 2 & 3
AV-101 (Tyrosine Kinase Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05036135 — Phase 2 & 3
~79 spots leftby Dec 2024
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