Phase 2 study comparing INBRX-101 to plasma-derived A1PI therapy for AATD emphysema

Phase 1

Recruiting

• Conditions: Alpha-1 Antitrypsin Deficiency (AATD) Emphysema; MedDRA version: 23.1Level: LLTClassification code: 10001806Term: Alpha-1 anti-trypsin deficiency Class: 10010331; Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]; Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]

• Registration Number: CTIS2023-508084-76-00
• Lead Sponsor: Inhibrx Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-12-21
• Last Update Posted: 21 August 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 94

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% and = 80% predicted at screening 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 selective or severe Immunoglobulin A (IgA) deficiency 4. Known or suspected diagnosis of type 1 diabetes or diagnosed with uncontrolled type 2 diabetes 5. Received IV immunoglobulins, monoclonal antibodies and/or other biologic therapies within 30 days 6. On waiting list for lung or liver transplant 7. Acute respiratory tract infection or COPD exacerbation within 4 weeks prior to or during screening 8. Evidence of decompensated cirrhosis 9. Active cancers or has a history of malignancy within 5 years prior to screening 10. History of unstable cor pulmonale 11. Clinically significant congestive heart failure

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified