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Prospective Phase 3 Multi-center 2-Year Placebo Controlled Double Blind Study to Evaluate the Efficacy and Safety of Kamada-AAT for Inhalation 80 Mg/Day in Alpha-1 Antitrypsin Deficiency with Moderate and Severe Airflow Limitation Followed by a 2-Year Open Label Extension

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Trial Profile

Prospective Phase 3 Multi-center 2-Year Placebo Controlled Double Blind Study to Evaluate the Efficacy and Safety of Kamada-AAT for Inhalation 80 Mg/Day in Alpha-1 Antitrypsin Deficiency with Moderate and Severe Airflow Limitation Followed by a 2-Year Open Label Extension

Status: Discontinued
Phase of Trial: Phase III

Latest Information Update: 18 Dec 2025

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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

  • 08 Dec 2025 According to a Kamada media release, company announced that the independent Data and Safety Monitoring Board (DSMB) advised the Company that, based on a prespecified interim futility analysis, the Phase 3 InnovAATe trial is unlikely to demonstrate a statistically significant benefit in its primary endpoint. Based on the futility analysis outcome, the Company will discontinue the trial.
  • 08 Dec 2025 Status changed from recruiting to discontinued.
  • 10 Nov 2025 According to a Kamada media release, Interim Futility Analysis to be Conducted in Current Quarter

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