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: 130 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

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. 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

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)

---

130 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