Study of INBRX-101 Compared to Plasma-derived A1PI Therapy in Adults With AATD Emphysema

• Status: Recruiting
• Trial end date: 2025-03-01
• Target enrollment: 0
• Participant gender: All

Summary

Phase 2 study to compare INBRX-101 to plasma derived A1PI therapy in adults with AATD emphysema

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Inhibrx, Inc.
• Treatments: Alpha 1-Antitrypsin

Criteria

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