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

April 8, 2026 updated by: Sanofi

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

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed 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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
185

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Trial Transparency email recommended (Toll free for US & Canada)
  • Phone Number: option 6 800-633-1610
  • Email: contact-us@sanofi.com

Study Locations

  • Australia
    • Queensland
      • Chermside, Queensland, Australia, 4032
        • Investigational Site Number : 202
      • South Brisbane, Queensland, Australia, 4101
        • Investigational Site Number : 204
    • South Australia
      • North Adelaide, South Australia, Australia, 5000
        • Investigational Site Number : 201
    • Victoria
      • Box Hill, Victoria, Australia, 3128
        • Investigational Site Number : 207
      • Fitzroy, Victoria, Australia, 3065
        • Investigational Site Number : 203
      • Frankston, Victoria, Australia, 3199
        • Investigational Site Number : 205
  • Denmark
      • Hellerup, Denmark, 2900
        • Investigational Site Number : 701
      • Vejle, Denmark, 7100
        • Investigational Site Number : 702
  • Ireland
    • Dublin
      • Dublin, Dublin, Ireland, D09 XR63
        • Investigational Site Number : 501
  • New Zealand
      • Auckland, New Zealand, 1051
        • Investigational Site Number : 403
      • Wellington, New Zealand, 6021
        • Investigational Site Number : 404
  • Poland
      • Krakow, Poland, 30-688
        • Investigational Site Number : 802
    • Masovian Voivodeship
      • Warsaw, Masovian Voivodeship, Poland, 01-138
        • Investigational Site Number : 801
  • Spain
      • Madrid, Spain, 28040
        • Investigational Site Number : 902
      • Santiago de Compostela, Spain, 15706
        • Investigational Site Number : 903
    • Cantabria
      • Santander, Cantabria, Spain, 39008
        • Investigational Site Number : 901
  • Sweden
      • Gothenburg, Sweden, 413 46
        • Investigational Site Number : 601
  • United Kingdom
      • Coventry, United Kingdom, CV2 2DX
        • Investigational Site Number : 309
    • Angus
      • Dundee, Angus, United Kingdom, DD1 9SY
        • Investigational Site Number : 308
    • Cheshire
      • Wythenshawe, Cheshire, United Kingdom, M23 9QZ
        • Investigational Site Number : 306
    • Devon
      • Exeter, Devon, United Kingdom, EX2 5DW
        • Investigational Site Number : 307
    • Hampshire
      • Southampton, Hampshire, United Kingdom, SO16 6YD
        • Investigational Site Number : 304
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35205-2610
        • UAB Lung Health Center- Site Number : 105
    • Arizona
      • Phoenix, Arizona, United States, 85013-4220
        • St Joseph's Hospital and Medical Center- Site Number : 126
    • California
      • Los Angeles, California, United States, 90095-3075
        • David Geffen School of Medicine at UCLA- Site Number : 124
      • Sacramento, California, United States, 95817-2201
        • University of California Davis Medical Center- Site Number : 110
    • Colorado
      • Denver, Colorado, United States, 80206-2761
        • National Jewish Medical and Research Center- Site Number : 123
    • Connecticut
      • Danbury, Connecticut, United States, 06810-5038
        • Nuvance Health Medical Practices, Pulmonary & Sleep Specialists- Site Number : 119
    • Florida
      • Gainesville, Florida, United States, 32610-3003
        • University of Florida - Gainesville - 1600 SW Archer Rd- Site Number : 101
    • Indiana
      • Indianapolis, Indiana, United States, 46202-5128
        • Indiana University- Site Number : 127
    • Massachusetts
      • Boston, Massachusetts, United States, 02115-6105
        • Brigham and Women's Hospital -75 Francis Street- Site Number : 131
    • Minnesota
      • Minneapolis, Minnesota, United States, 55455-0341
        • University of Minnesota-420 Delaware Str SE- Site Number : 125
    • Missouri
      • Hannibal, Missouri, United States, 63401-6890
        • Hannibal Regional Healthcare System-HRMG-Hannibal- Site Number : 111
    • New York
      • New York, New York, United States, 10032-3729
        • Columbia University Irving Medical Center- Site Number : 104
    • Oregon
      • Portland, Oregon, United States, 97239-3011
        • Oregon Health and Science University- Site Number : 117
    • Pennsylvania
      • Hershey, Pennsylvania, United States, 17033-2360
        • Penn State Health Milton S. Hershey Medical Center- Site Number : 122
      • Philadelphia, Pennsylvania, United States, 19140-5103
        • Temple University Hospital - 3401 N Broad St- Site Number : 130
    • South Carolina
      • Spartanburg, South Carolina, United States, 29303-4225
        • Velocity Clinical Research - Spartanburg - PPDS- Site Number : 120
    • Texas
      • Houston, Texas, United States, 77030-2703
        • Houston Methodist Hospital- Site Number : 113
    • Utah
      • Salt Lake City, Utah, United States, 84132-0001
        • University of Utah Health Care- Site Number : 106

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: SAR447537 (INBRX-101)
A1PI, Recombinant, Bivalent Fc Fusion Protein, in a solution for intravenous injection
Drug: SAR447537
A1PI, Recombinant, Bivalent Fc Fusion Protein

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Long-term safety and tolerability
Time Frame: 3 years
Incidence of all treatment emergent adverse events (TEAEs), TEAEs ≥ Grade 3, serious adverse events (SAEs), TEAEs leading to discontinuation from SAR447537, and adverse events of special interest (AESIs) (including infusion-related reactions).
3 years

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Trough serum functional AAT (fAAT) concentration changes
Time Frame: 3 years
Change in fAAT concentration levels from baseline to end of treatment
3 years
Change in lung density by quantitative computerized tomography (CT)
Time Frame: 3 years
Assess the annual rate of change in lung density assessed by serial quantitative CT (15th percentile point, PD15) at total lung capacity (TLC), centrally read, from baseline to end of treatment (EoT).
3 years
Trough SAR447537 concentration changes
Time Frame: 3 years
Change in SAR447537 concentration levels from baseline to end of treatment
3 years
Covariate Analysis: Biometric Values: Weight
Time Frame: 3 years
Assessment of the impact of participant's weight [in kg] on the pharmacokinetic profile of SAR447537
3 years
Covariate Analysis: Biometric Values: Height
Time Frame: 3 years
Assessment of the impact of participant's height [in cm] on the pharmacokinetic profile of SAR447537
3 years
Covariate Analysis: Biometric Values: Age
Time Frame: 3 years
Assessment of the impact of participant's age [in years] on the pharmacokinetic profile of SAR447537
3 years
Covariate Analysis: Biometric Values: Sex
Time Frame: 3 years
Assessment of the impact of participant's sex [male or female] on the pharmacokinetic profile of SAR447537
3 years
Anti-drug antibodies
Time Frame: 3 years
Frequency of anti-drug antibodies (ADA) against SAR447537 as well as neutralizing ADA (NAb) against SAR447537
3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Sanofi

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Clinical Sciences & Operations, Sanofi

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 20, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 30, 2028

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 30, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 31, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 31, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 9, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 13, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 8, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • INBRX101-01-202
  • 2023-508137-14-00 (Registry Identifier: CTIS)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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