Alpha 1-Antitrypsin DeficiencyPhase 2ELEVAATE OLENCT05897424
Long-term, Open-label Study of SAR447537 (INBRX-101) in Adults With Alpha-1 Antitrypsin Deficiency Emphysema
A Phase 2 study testing SAR447537 in people with Alpha 1-Antitrypsin Deficiency and Emphysema, run by Sanofi at 40 sites in 9 countries.
Trial summary
Phase 2 open label extension study to evaluate SAR447537 (INBRX-101) in adults with AATD emphysema Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Alpha 1-Antitrypsin Deficiency, Emphysema
- What is being tested?
- SAR447537
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 185 participants
- Where
- 40 sitesin 9 countries
- Study dates
- 20 Jun 2024to 30 Sep 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Males or females 18-80 years of age, inclusive, at the time of screening
- Diagnosis of AATD
- Evidence of emphysema secondary to AATD
- FEV1 of ≥ 30% predicted at screening and post-bronchodilator FEV1/FVC<0.7
- Current non-smoking status
Who cannot join
- For newly identified participants
- Receipt of A1PI augmentation therapy within 5 weeks prior to the first dose of study drug
- Known or suspected allergy to components of SAR447537, A1PI or human IgG
- Uncontrolled diabetes mellitus despite adequate antidiabetic pharmacologic treatment with a screening HbA1c value ≥9%
- Received IV immunoglobulins, monoclonal antibodies and/or other biologic therapies within 30 days
- On waiting list for lung or liver transplant
Show all 11Show fewer
- Acute respiratory tract infection or COPD exacerbation within 4 weeks prior to or during screening
- Evidence of decompensated cirrhosis
- Active cancers or has a history of malignancy within 5 years prior to screening
- 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 locations and contacts
40 sites in 9 countries.
40 sites in 9 countries
United States18 sites
UAB Lung Health Center- Site Number : 105
Birmingham, Alabama, 35205-2610
Brigham and Women's Hospital -75 Francis Street- Site Number : 131
Boston, Massachusetts, 02115-6105
Nuvance Health Medical Practices, Pulmonary & Sleep Specialists- Site Number : 119
Danbury, Connecticut, 06810-5038
National Jewish Medical and Research Center- Site Number : 123
Denver, Colorado, 80206-2761
University of Florida - Gainesville - 1600 SW Archer Rd- Site Number : 101
Gainesville, Florida, 32610-3003
Hannibal Regional Healthcare System-HRMG-Hannibal- Site Number : 111
Hannibal, Missouri, 63401-6890
Penn State Health Milton S. Hershey Medical Center- Site Number : 122
Hershey, Pennsylvania, 17033-2360
Houston Methodist Hospital- Site Number : 113
Houston, Texas, 77030-2703
Indiana University- Site Number : 127
Indianapolis, Indiana, 46202-5128
David Geffen School of Medicine at UCLA- Site Number : 124
Los Angeles, California, 90095-3075
University of Minnesota-420 Delaware Str SE- Site Number : 125
Minneapolis, Minnesota, 55455-0341
Columbia University Irving Medical Center- Site Number : 104
New York, New York, 10032-3729
Temple University Hospital - 3401 N Broad St- Site Number : 130
Philadelphia, Pennsylvania, 19140-5103
St Joseph's Hospital and Medical Center- Site Number : 126
Phoenix, Arizona, 85013-4220
Oregon Health and Science University- Site Number : 117
Portland, Oregon, 97239-3011
University of California Davis Medical Center- Site Number : 110
Sacramento, California, 95817-2201
University of Utah Health Care- Site Number : 106
Salt Lake City, Utah, 84132-0001
Velocity Clinical Research - Spartanburg - PPDS- Site Number : 120
Spartanburg, South Carolina, 29303-4225
Australia6 sites
Investigational Site Number : 207
Box Hill, Victoria, 3128
Investigational Site Number : 202
Chermside, Queensland, 4032
Investigational Site Number : 203
Fitzroy, Victoria, 3065
Investigational Site Number : 205
Frankston, Victoria, 3199
Investigational Site Number : 201
North Adelaide, South Australia, 5000
Investigational Site Number : 204
South Brisbane, Queensland, 4101
United Kingdom5 sites
Investigational Site Number : 309
Coventry, CV2 2DX
Investigational Site Number : 308
Dundee, Angus, DD1 9SY
Investigational Site Number : 307
Exeter, Devon, EX2 5DW
Investigational Site Number : 304
Southampton, Hampshire, SO16 6YD
Investigational Site Number : 306
Wythenshawe, Cheshire, M23 9QZ
Spain3 sites
Investigational Site Number : 902
Madrid, 28040
Investigational Site Number : 901
Santander, Cantabria, 39008
Investigational Site Number : 903
Santiago de Compostela, 15706
Denmark2 sites
Investigational Site Number : 701
Hellerup, 2900
Investigational Site Number : 702
Vejle, 7100
New Zealand2 sites
Investigational Site Number : 403
Auckland, 1051
Investigational Site Number : 404
Wellington, 6021
Poland2 sites
Investigational Site Number : 802
Krakow, 30-688
Investigational Site Number : 801
Warsaw, Masovian Voivodeship, 01-138
About this study
Official title: 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
Read the 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.
- Conditions
- Alpha 1-Antitrypsin Deficiency, Emphysema
- Being tested
- SAR447537
- Keywords
- AATD, Alpha 1-Antitrypsin Deficiency, Emphysema, INBRX-101, AAT, SAR447537
- Medical subject headings
- alpha 1-Antitrypsin Deficiency, Emphysema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SAR447537Drug
A1PI, Recombinant, Bivalent Fc Fusion Protein
| Study group | Role | What they receive |
|---|---|---|
| SAR447537 (INBRX-101) | Experimental | A1PI, Recombinant, Bivalent Fc Fusion Protein, in a solution for intravenous injection Receives: Drug: SAR447537 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Long-term safety and tolerability
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).
Measured: 3 years
Secondary outcomes (8)
Change in lung density by quantitative computerized tomography (CT)
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).
Measured: 3 years
Trough SAR447537 concentration changes
Change in SAR447537 concentration levels from baseline to end of treatment
Measured: 3 years
Trough serum functional AAT (fAAT) concentration changes
Change in fAAT concentration levels from baseline to end of treatment
Measured: 3 years
Covariate Analysis: Biometric Values: Weight
Assessment of the impact of participant's weight [in kg] on the pharmacokinetic profile of SAR447537
Measured: 3 years
Covariate Analysis: Biometric Values: Height
Assessment of the impact of participant's height [in cm] on the pharmacokinetic profile of SAR447537
Measured: 3 years
Covariate Analysis: Biometric Values: Age
Assessment of the impact of participant's age [in years] on the pharmacokinetic profile of SAR447537
Measured: 3 years
Covariate Analysis: Biometric Values: Sex
Assessment of the impact of participant's sex [male or female] on the pharmacokinetic profile of SAR447537
Measured: 3 years
Anti-drug antibodies
Frequency of anti-drug antibodies (ADA) against SAR447537 as well as neutralizing ADA (NAb) against SAR447537
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2023
- Study start20 Jun 2024
- Primary completion30 Jun 2028 (estimated)
- Study completion30 Sep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alpha 1-Antitrypsin DeficiencyStudies of the same condition, open and under way.
- More trials run by SanofiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Multicenter, single arm, open-label extension study
- Masking
- None (open label)
- Enrolment
- 185 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Sciences & Operations, Study director, Sanofi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05897424
- Sponsor's protocol ID
- INBRX101-01-202
- Other IDs
- 2023-508137-14-00, 2023
- Acronym
- ELEVAATE OLE
- Status last verified
- Apr 2026
- First submitted
- 31 May 2023
- Last updated
- 13 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT05897424
- Acronym / sponsor ID
- ELEVAATE OLE / INBRX101-01-202
- Conditions
- Alpha 1-Antitrypsin Deficiency, Emphysema
- Keywords
- AATD, Alpha 1-Antitrypsin Deficiency, Emphysema, INBRX-101, AAT, SAR447537
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 185 participants (estimated)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Study start
- 20 Jun 2024 (actual)
- Primary completion
- 30 Jun 2028 (estimated)
- Study completion
- 30 Sep 2028 (estimated)
- First posted
- 9 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Phase 2 open label extension study to evaluate SAR447537 (INBRX-101) in adults with AATD emphysema
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Multicenter, single arm, open-label extension study
| Arm | Type | Receives |
|---|---|---|
| SAR447537 (INBRX-101) | Experimental | Drug: SAR447537A1PI, Recombinant, Bivalent Fc Fusion Protein, in a solution for intravenous injection |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Males or females 18-80 years of age, inclusive, at the time of screening
- Diagnosis of AATD
- Evidence of emphysema secondary to AATD
- FEV1 of ≥ 30% predicted at screening and post-bronchodilator FEV1/FVC<0.7
- Current non-smoking status
Key exclusion criteria (11 listed)
- For newly identified participants
- Receipt of A1PI augmentation therapy within 5 weeks prior to the first dose of study drug
- Known or suspected allergy to components of SAR447537, A1PI or human IgG
- Uncontrolled diabetes mellitus despite adequate antidiabetic pharmacologic treatment with a screening HbA1c value ≥9%
- Received IV immunoglobulins, monoclonal antibodies and/or other biologic therapies within 30 days
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SAR447537A1PI, Recombinant, Bivalent Fc Fusion Protein | Drug | SAR447537 (INBRX-101) |
Primary outcome
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).
8 secondary outcomes
Change in lung density by quantitative computerized tomography (CT)
Time frame: 3 years
Trough SAR447537 concentration changes
Time frame: 3 years
Trough serum functional AAT (fAAT) concentration changes
Time frame: 3 years
Covariate Analysis: Biometric Values: Weight
Time frame: 3 years
Covariate Analysis: Biometric Values: Height
Time frame: 3 years
Covariate Analysis: Biometric Values: Age
Time frame: 3 years
Covariate Analysis: Biometric Values: Sex
Time frame: 3 years
Anti-drug antibodies
Time frame: 3 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2026.
- INBRX101-01-202 Plain Language Results SummaryLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. 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
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinical Sciences & Operations study director
Sanofi
40 sites in 9 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing SAR447537 in people with Alpha 1-Antitrypsin Deficiency and Emphysema, run by Sanofi at 40 sites in 9 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 13 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 40 sites in United States, Australia, United Kingdom, Spain, Denmark and 4 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Long-term safety and tolerability (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2026.