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A Prospective Phase III Multi-center, 2-Year Placebo Controlled, Double Blind Study to Evaluate the Efficacy and Safety of "Kamada-AAT for Inhalation" 80 mg per day in Adult Patients with Congenital Alpha-1 Antitrypsin Deficiency with Moderate and Severe Airflow Limitation (40% ≤ FEV1 ≤ 80% of predicted; FEV1/SVC ≤ 70%), Followed by a 2-Year Open-Label Extension

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Trial Profile

A Prospective Phase III Multi-center, 2-Year Placebo Controlled, Double Blind Study to Evaluate the Efficacy and Safety of "Kamada-AAT for Inhalation" 80 mg per day in Adult Patients with Congenital Alpha-1 Antitrypsin Deficiency with Moderate and Severe Airflow Limitation (40% ≤ FEV1 ≤ 80% of predicted; FEV1/SVC ≤ 70%), Followed by a 2-Year Open-Label Extension

Status: Recruiting
Phase of Trial: Phase III

Latest Information Update: 14 May 2024

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At a glance

  • Drugs Alpha 1-antitrypsin (Primary) ; Alpha 1-antitrypsin
  • Indications Alpha 1-antitrypsin deficiency
  • Focus Registrational; Therapeutic Use
  • Acronyms InnovAATe
  • Sponsors Kamada
  • Most Recent Events

    • 07 May 2024 According to a Kamada media release, Following recent positive feedback from the U.S. Food and Drug Administration (FDA) through which the FDA expressed its willingness to potentially accept a P<0.1 alpha level in evaluating InnovAATe for meeting the efficacy primary endpoint for registration, we recently filed an IND amendment with both a revised Statistical Analysis Plan (SAP) and study protocol, and we expect further FDA feedback during the second half of 2024
    • 07 Mar 2024 According to a Kamada media release,the company is planning to present a revised statistical analysis plan (SAP) and study protocol for the InnovAATe study and to seek the FDA feedback by mid-2024
    • 21 Sep 2023 Results assessing the impact of Dutch governmental NPI's on the COPD exacerbations and respiratory infections rate in patients with severe alpha-1 antitrypsin deficiency published in the COPD: Journal of Chronic Obstructive Pulmonary Disease
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