This is a Phase 2, Single Arm, Open Label Extension Study, Evaluating the Long-Term Safety and Clinical Efficacy of INBRX-101 in Adults With Alpha-1 Antitrypsin Deficiency (AATD) Emphysema.

INBRX101-01-202

Phase 2 open label extension study to evaluate INBRX-101 in adults with AATD emphysema

2024-06-01

2027-09-01

2027-12-01

Not yet recruiting

Early phase I

130

Inclusion Criteria: 1. Males or females 18-80 years of age, inclusive, at the time of screening 2. Diagnosis of AATD 3. Evidence of emphysema secondary to AATD 4. FEV1 of ≥ 30% predicted at screening and post-bronchodilator FEV1/FVC\<0.7 (Cohort 1 new patients only) 5. Current non-smoking status Exclusion Criteria: 1. Receipt of A1PI augmentation therapy within 5 weeks prior to the first dose of study drug 2. Known or suspected allergy to components of INBRX-101, A1PI or human IgG 3. Known or suspected diagnosis of type 1 diabetes or diagnosed with uncontrolled type 2 diabetes 4. Received IV immunoglobulins, monoclonal antibodies and/or other biologic therapies within 30 days 5. On waiting list for lung or liver transplant 6. Acute respiratory tract infection or COPD exacerbation within 4 weeks prior to or during screening 7. Evidence of decompensated cirrhosis 8. Active cancers or has a history of malignancy within 5 years prior to screening 9. History of unstable cor pulmonale 10. Clinically significant congestive heart failure

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Multicenter, single arm, open-label extension study', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 130, 'type': 'ESTIMATED'}}

2024-03-05