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Long-term, Open-label Study o...

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

Last Updated: 2025-10-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE2

Total Enrollment

185 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-06-20

Study Completion Date

2028-09-30

Brief Summary

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

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Detailed Description

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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.

Conditions

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Alpha 1-Antitrypsin Deficiency Emphysema

Study Design

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Allocation Method

Intervention Model

SINGLE_GROUP

Multicenter, single arm, open-label extension study

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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SAR447537 (INBRX-101)

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

Group Type EXPERIMENTAL

SAR447537

Intervention Type DRUG

A1PI, Recombinant, Bivalent Fc Fusion Protein

Interventions

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SAR447537

A1PI, Recombinant, Bivalent Fc Fusion Protein

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Clinical Sciences & Operations

Role: STUDY_DIRECTOR

Sanofi

Locations

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