NCT05856331
Study of INBRX-101 Compared to Plasma-derived A1PI Therapy in Adults With AATD Emphysema
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PHASE2
RECRUITING
NCT05856331
INTERVENTIONAL
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
Phase 2 study to compare INBRX-101 to plasma derived A1PI therapy in adults with AATD emphysema
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
Alpha 1-Antitrypsin Deficiency
Emphysema
- 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)
- Sanofi