Open Label Extension Study of INBRX-101 in Adults With AATD Emphysema (ELEVAATE OLE)
Alpha 1-Antitrypsin Deficiency, Emphysema
About this trial
This is an interventional treatment trial for Alpha 1-Antitrypsin Deficiency focused on measuring AATD, Alpha 1-Antitrypsin Deficiency, Emphysema, INBRX-101, AAT
Eligibility Criteria
Inclusion Criteria: 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% predicted at screening and post-bronchodilator FEV1/FVC<0.7 (Cohort 1 new patients only) Current non-smoking status Exclusion Criteria: Receipt of A1PI augmentation therapy within 5 weeks prior to the first dose of study drug Known or suspected allergy to components of INBRX-101, A1PI or human IgG Known or suspected diagnosis of type 1 diabetes or diagnosed with uncontrolled type 2 diabetes Received IV immunoglobulins, monoclonal antibodies and/or other biologic therapies within 30 days On waiting list for lung or liver transplant Acute respiratory tract infection or COPD exacerbation within 4 weeks prior to or during screening Evidence of decompensated cirrhosis Active cancers or has a history of malignancy within 5 years prior to screening History of unstable cor pulmonale Clinically significant congestive heart failure
Sites / Locations
Arms of the Study
Arm 1
Experimental
INBRX-101 Q3W
IV every 3-weeks (Q3W)