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InnovAATe: Kamada-AAT for Inhalation in Alpha-1 Antitrypsin Deficiency
NCT04204252Phase 3
Key facts
- Status
- Terminated
- Start
- Nov 2019
- Primary completion
- Feb 2026
- Countries
- 6
- Sponsor
- Kamada Ltd.
- Modality
- Recombinant Proteins and Enzymes
- Conditions
- alpha-1 antitrypsin deficiency (AATD)
01
Overview
Phase 3, randomised, double-blind trial in alpha-1 antitrypsin deficiency (AATD) comparing Inhaled AAT with Placebo (2 arms). Primary endpoint: Forced Expiratory Volume in 1 second post bronchodilator at 104 weeks. Started Nov 2019; status: terminated.
02
Design
2 arms- Study design
- RandomizedDouble-blind
Inhaled AAT
Daily inhalation of 80 mg/day Kamada-AAT for Inhalation
Placebo
Daily inhalation of a solution of NaCl in phosphate buffer solution with 0.01% TWEEN-80
03
Who it enrols
Adults aged 18-65 with severe Alpha 1-Antitrypsin Deficiency (Pi(ZZ), Pi(Z/Null), or Pi(Null/Null) genotypes), serum AAT <= 11 uM, and clinical evidence of moderate to severe airflow limitation. Must be naive or washed out of AAT treatment for 8 weeks. Excludes patients with IgA deficiency, recent severe exacerbations, recent lung/liver transplant, or active smoking/substance abuse.
04
Endpoints
Primary
Forced Expiratory Volume in 1 second post bronchodilator
Secondary
CT densitometry whole-lung 15th percentile lung density at total lung capacity
Forced Expiratory Volume in 1 second percentage of predicted
Ratio of Forced Expiratory Volume in 1 second to Forced Vital Capacity
Number of Exacerbations
6 minute walk test
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