AV-101 for Pulmonary Arterial Hypertension

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Pulmonary Arterial Hypertension+6 MoreAV-101 - Drug
Eligibility
18 - 75
All Sexes
What conditions do you have?
Select

Study 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.

Eligible Conditions
  • Pulmonary Arterial Hypertension

Treatment Effectiveness

Study Objectives

2 Primary · 11 Secondary · Reporting Duration: 24 weeks

24 weeks
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 Pulmonary Vascular Resistance (PVR)
Phase 2b: Change from Baseline in Registry to Evaluate Early and Long-Term PAH Disease Management (REVEAL) Lite 2.0 Risk Score
Phase 2b: Change from Baseline in Six Minute Walk Distance (6MWD)
Phase 2b: Incidence of Clinical Worsening
Phase 2b: Proportion of Subjects with Improvement in WHO Functional Class
Phase 3: Change from Baseline in NT-proBNP
Phase 3: Change from Baseline in Pulmonary Arterial Hypertension-Symptoms and Impact (PAH-SYMPACT) Questionnaire Score
Phase 3: Change from Baseline in Registry to Evaluate Early and Long-Term PAH Disease Management (REVEAL) Lite 2.0 Risk Score
Phase 3: Change from Baseline in Six Minute Walk Distance (6MWD)
Phase 3: Proportion of Subjects with Improvement in WHO Functional Class
Phase 3: Time to Clinical Worsening

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Trial Design

6 Treatment Groups

Phase 2b high dose AV-101
1 of 6
Phase 2b low dose AV-101
1 of 6
Phase 2b medium dose AV-101
1 of 6
Phase 3 dose AV-101 (Optimal dose selected in Phase 2b)
1 of 6
Phase 2b Placebo
1 of 6
Phase 3 Placebo
1 of 6

Experimental Treatment

Non-Treatment Group

462 Total Participants · 6 Treatment Groups

Primary Treatment: AV-101 · Has Placebo Group · Phase 2 & 3

Phase 2b high dose AV-101
Drug
Experimental Group · 1 Intervention: AV-101 · Intervention Types: Drug
Phase 2b low dose AV-101
Drug
Experimental Group · 1 Intervention: AV-101 · Intervention Types: Drug
Phase 2b medium dose AV-101
Drug
Experimental Group · 1 Intervention: AV-101 · Intervention Types: Drug
Phase 3 dose AV-101 (Optimal dose selected in Phase 2b)
Drug
Experimental Group · 1 Intervention: AV-101 · Intervention Types: Drug
Phase 2b Placebo
Drug
PlaceboComparator Group · 1 Intervention: Placebo · Intervention Types: Drug
Phase 3 Placebo
Drug
PlaceboComparator Group · 1 Intervention: Placebo · Intervention Types: Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
AV-101
Not yet FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 24 weeks

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

Eligibility Criteria

Age 18 - 75 · All Participants · 8 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
, and NH3 I, HPAH, PAH-CTD, and NH3 are all chemicals.
is recommended in patients with newly diagnosed, IPF Patients with newly diagnosed IPF should receive stable background therapy with at least two approved medications for PAH.
The World Health Organization (WHO) has classified symptoms into three categories: functional class II, III, or IV
PAH that is the result of drug and/or toxin/chemical abuse that has been in the care of the investigator for at least one year with no relapses of drug or toxin/chemical abuse.
People with HIV and congenital heart disease who have had their heart repaired at least a year ago are at risk for HIV-associated pulmonary arterial hypertension (HIV-PAH).
The person is able to walk a distance of at least 100 m but no more than 475 m during the Screening 6-minute walk tests.

Who else is applying?

What state do they live in?
Florida100.0%
How old are they?
18 - 65100.0%
What portion of applicants met pre-screening criteria?
Did not meet criteria100.0%