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

Sanofi

Status and phase: Enrolling; Phase 2

Conditions: Emphysema; Alpha 1-Antitrypsin Deficiency

Treatments: Drug: Zemaira; Drug: INBRX-101

Study type: Interventional

Funder types: Industry

Identifiers

NCT05856331

2023-508084-76-00 (EU Trial (CTIS) Number)

INBRX101-01-201

Details and patient eligibility

About

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

Full description

This is a 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.

Enrollment: 90 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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90 participants in 3 patient groups

INBRX-101 Q3W

Experimental group

Description:

IV every 3-weeks (Q3W) and placebo (normal saline)

Treatment:

Drug: INBRX-101

INBRX-101 Q4W

Experimental group

Description:

IV every 4-weeks (Q4W) and placebo (normal saline)

Treatment:

Drug: INBRX-101

Zemaira (A1PI)

Active Comparator group

Description:

60 mg/kg IV once weekly (QW) and placebo (normal saline)

Treatment:

Drug: Zemaira