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The trial is taking place at:
K

Kaiser Permanente Los Angeles Medical Center | Department of Research and Evaluation

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A Study of AV-101 (Dry Powder Inhaled Imatinib) in Patients With Pulmonary Arterial Hypertension (PAH) (IMPAHCT)

A

Aerovate Therapeutics

Status and phase

Active, not recruiting
Phase 3
Phase 2

Conditions

Pulmonary Arterial Hypertension

Treatments

Drug: AV-101
Drug: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT05036135
AV-101-002

Details and patient eligibility

About

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.

Enrollment

462 estimated patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

Key Inclusion Criteria

  • PAH belonging to one of the subgroups:

    1. I/HPAH, PAH-CTD,
    2. 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),
    3. HIV associated or
    4. PAH due to repaired congenital heart disease (at least 1 year since repair)
  • World Health Organization (WHO) Functional Class II, III or IV symptoms

  • Stable concomitant background therapy of at least one PAH approved medications

  • Able to walk a distance of at least 100 m but no more than 475 m during the Screening 6-minute walk tests.

Key Exclusion Criteria

  • Pulmonary hypertension (PH) belonging to Groups 2 to 5
  • A history of left-sided heart disease
  • Pregnant or breast-feeding females

Additional criteria may apply, per protocol

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

462 participants in 6 patient groups, including a placebo group

Phase 2b low dose AV-101
Experimental group
Treatment:
Drug: AV-101
Phase 2b medium dose AV-101
Experimental group
Treatment:
Drug: AV-101
Phase 2b high dose AV-101
Experimental group
Treatment:
Drug: AV-101
Phase 2b Placebo
Placebo Comparator group
Treatment:
Drug: Placebo
Phase 3 dose AV-101 (Optimal dose selected in Phase 2b)
Experimental group
Treatment:
Drug: AV-101
Phase 3 Placebo
Placebo Comparator group
Treatment:
Drug: Placebo

Trial contacts and locations

129

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Central trial contact

Toll Free Number

Data sourced from clinicaltrials.gov

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