Long-term, Open-label Study of SAR447537 (INBRX-101) in Adults With Alpha-1 Antitrypsin Deficiency Emphysema (ELEVAATE OLE)

Sanofi

Status and phase: Enrolling; Phase 2

Conditions: Emphysema; Alpha 1-Antitrypsin Deficiency

Treatments: Drug: SAR447537

Study type: Interventional

Funder types: Industry

Identifiers

NCT05897424

INBRX101-01-202

2023-508137-14-00 (EU Trial (CTIS) Number)

Details and patient eligibility

About

Phase 2 open label extension study to evaluate SAR447537 (INBRX-101) in adults with AATD emphysema

Full description

This is a Phase 2, Single Arm, Open Label Extension Study, Evaluating the Long-Term Safety and Clinical Efficacy of SAR447537 (INBRX-101) in Adults With Alpha-1 Antitrypsin Deficiency (AATD) Emphysema.

Enrollment: 185 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% predicted at screening and post-bronchodilator FEV1/FVC<0.7
5. Current non-smoking status

Exclusion criteria

For newly identified participants

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 SAR447537, A1PI or human IgG
3. Uncontrolled diabetes mellitus despite adequate antidiabetic pharmacologic treatment with a screening HbA1c value ≥9%
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

The above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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185 participants in 1 patient group

SAR447537 (INBRX-101)

Experimental group

Description:

A1PI, Recombinant, Bivalent Fc Fusion Protein, in a solution for intravenous injection

Treatment:

Drug: SAR447537