NCT05856331

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

Official Title:

Phase 2, Double-Blind, Randomized, Active-Control, Parallel Group Study to Assess the Pharmacokinetics, Pharmacodynamics, Immunogenicity, and Safety of INBRX-101 Compared to Plasma-Derived Alpha1-Proteinase Inhibitor (A1PI) Augmentation Therapy in Adults With Alpha-1 Antitrypsin Deficiency (AATD) Emphysema

Summary

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

Eligibility

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

Disease(s) and\or Condition(s)

Alpha 1-Antitrypsin Deficiency

Emphysema

Primary Purpose
  • TREATMENT
Intervention/Treatment
    • Type: DRUG
    • Name: INBRX-101
    • Description: A1PI, Recombinant, Bivalent Fc Fusion Protein
    • Arm Group Labels: INBRX-101 Q3W, INBRX-101 Q4W
    • Type: DRUG
    • Name: Zemaira
    • Description: Alpha1-Proteinase Inhibitor (Human)
    • Arm Group Labels: Zemaira (A1PI)
Sponsor
  • Sanofi