ElevAAte - New Treatment for Adults with Alpha-1 Antitrypsin Deficiency (AATD) Emphysems

Who can take part?

• Males or females 18-80 years of age, inclusive, at the time of screening
• Diagnosis of AATD
• Evidence of emphysema secondary to AATD
• FEV1 of ≥ 30% and ≤ 80% predicted at screening
• Current non-smoking status.

What is involved for you?

Your participation will last up to 51 weeks;

• Screening Period (up to 7 weeks – 2 Visits) 
• Treatment Period (32 weeks – 10 Visits)(You will have to visit the study center weekly once study drug is assigned to you until the end of the treatment period)
• Safety Follow-up Period (12 weeks – 2 Visits) 

Study Events:

• Ability to give informed consent
• Eligibility A1P1 genotype confirmation
• Demographics
• Medical and Smoking History
• Physical Examination
• Height and Weight
• Vital Signs
• Prior and concomitant medication, therapies and procedures
• Adverse Events
• Pulmonary exacerbation event assessments
• Eligibility safety laboratory test
• Eligibility antigenic AAT lab test
• Pregnancy Test
• Urine Drug Test
• Electrocardiogram (ECG)
• Nasal brushing/swab for biomarker
• Pulmonary function tests
• Patient reported questionnaires
• CT Scan
• Blood Tests

Trial dates

October 2023 - March 2025