Study of INBRX-101 Compared to Plasma-derived A1PI Therapy in Adults With AATD Emphysema (ELEVAATE)
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, A1PI, 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% and ≤ 80% predicted at screening 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 selective or severe Immunoglobulin A (IgA) deficiency 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
- University of Alabama at BirminghamRecruiting
- St Joseph's Hospital and Medical Center
- David Geffen School of Medicine at UCLA
- UC Davis Medical Center
- National Jewish Medical and Research Center
- Western Connecticut Medical GroupRecruiting
- GW Medical Faculty Associates - GW Cancer& Blood Disorders
- GW Medical Faculty AssociatesRecruiting
- University of FloridaRecruiting
- University of Miami
- Pulmonary and Sleep of Tampa Bay
- Cleveland Clinic Florida
- University of Chicago
- Loyola University Medical Center
- Indiana University
- M Health Fairview Clinics and Surgery Center - Minneapolis
- Hannibal ClinicRecruiting
- Columbia University
- Oregon Health and Science UniversityRecruiting
- Clinical Research Associates Of Central PA , LLC
- Penn State Health Milton S. Hershey Medical Center
- Velocity Clinical Research - Spartanburg - PPDSRecruiting
- Houston Methodist Hospital
- University of Utah Health
- Donna McIntyreRecruiting
- Queensland Centre for Pulmonary TransplantationRecruiting
- Royal Adelaide Hospital
- Eastern Health Clinical School
- St Vincent Hospital MelbourneRecruiting
- Frankston HospitalRecruiting
- NZRSIRecruiting
- Ninewells Hospital - PPDS
- Medicines Evaluation Unit
- Royal Devon and Exeter Hospital (Wonford) - Barrack Rd
- Southampton General Hospital
- Queen Elizabeth Hospital Birmingham
- Royal Infirmary of Edinburgh - PPDS
Arms of the Study
Arm 1
Arm 2
Arm 3
Experimental
Experimental
Active Comparator
INBRX-101 Q3W
INBRX-101 Q4W
Zemaira (A1PI)
IV every 3-weeks (Q3W) and placebo (normal saline)
IV every 4-weeks (Q4W) and placebo (normal saline)
60 mg/kg IV once weekly (QW) and placebo (normal saline)