Inhaled Imatinib Pulmonary Arterial Hypertension Clinical Trial (IMPAHCT) or A Phase 2b/3, Randomized, Controlled, 24-week Dose Ranging and Confirmatory Study of AV-101 in Patients with PAH

Phase 1

• Conditions: Pulmonary Arterial Hypertension (PAH); MedDRA version: 20.0Level: LLTClassification code: 10077740Term: Pulmonary arterial hypertension WHO functional class II Class: 10038738; MedDRA version: 21.1Level: PTClassification code: 10064911Term: Pulmonary arterial hypertension Class: 100000004855; MedDRA version: 20.0Level: LLTClassification code: 10077729Term: Pulmonary arterial hypertension WHO functional class III Class: 10038738; MedDRA version: 20.0Level: LLTClassification code: 10077730Term: Pulmonary arterial hypertension WHO functional class IV Class: 10038738; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: CTIS2023-508734-34-00
• Lead Sponsor: Aerovate Therapeutics Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-02-01
• Study Completion: 2024-08-09
• Last Update Posted: 21 August 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 462

Inclusion Criteria

Male or female between 18 and 75 years of age inclusive at the Screening Visit, A diagnosis of PAH belonging to one of the subgroups of the NICE classification of Group 1*: a. I/HPAH, PAH-CTD, b. PAH due to drugs and/or toxins/chemicals (having been in the care of the investigator for at least one year with no relapses of drug or toxin/chemical abuse), c. HIV associated or d. PAH due to repaired congenital heart disease (at least 1 year since repair). *Excluding patients with Portopulmonary Hypertension, World Health Organization (WHO) Functional Class II, III or IV symptoms, Must be able to walk a distance of at least 100 m but no more than 475 m during the screening 6-minute walk test.

Exclusion Criteria

Pulmonary hypertension (PH) belonging to Groups 2 to 5 of the 2018 NICE classification and Group 1 diagnosed with Portopulmonary Hypertension., A history of left ventricular ejection fraction (LVEF) = 40% on echocardiogram within 12 months of screening, or clinically significant ischemic, mitral or aortic valve disease, or constrictive heart disease, in the opinion of the Investigator, Pregnant or breast-feeding females

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified