Open Label Extension Study of INBRX-101 in Adults With AATD Emphysema

• Status: Not yet recruiting
• Trial end date: 2027-12-01
• Target enrollment: 0
• Participant gender: All

Summary

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

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

Details

• Lead Sponsor: Inhibrx, Inc.

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% 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