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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT05897424
Registration number
NCT05897424
Ethics application status
Date submitted
31/05/2023
Date registered
9/06/2023
Date last updated
11/07/2025
Titles & IDs
Public title
Long-term, Open-label Study of SAR447537 (INBRX-101) in Adults With Alpha-1 Antitrypsin Deficiency Emphysema
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Scientific 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
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Secondary ID [1]
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2023-508137-14-00
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Secondary ID [2]
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INBRX101-01-202
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Universal Trial Number (UTN)
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Trial acronym
ELEVAATE OLE
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Alpha 1-Antitrypsin Deficiency
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Emphysema
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Condition category
Condition code
Human Genetics and Inherited Disorders
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Other human genetics and inherited disorders
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Respiratory
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Other respiratory disorders / diseases
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - SAR447537
Experimental: SAR447537 (INBRX-101) - A1PI, Recombinant, Bivalent Fc Fusion Protein, in a solution for intravenous injection
Treatment: Drugs: SAR447537
A1PI, Recombinant, Bivalent Fc Fusion Protein
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Long-term safety and tolerability
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Assessment method [1]
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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).
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Timepoint [1]
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3 years
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Secondary outcome [1]
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Change in lung density by quantitative computerized tomography (CT)
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Assessment method [1]
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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).
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Timepoint [1]
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3 years
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Secondary outcome [2]
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Trough SAR447537 concentration changes
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Assessment method [2]
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Change in SAR447537 concentration levels from baseline to end of treatment
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Timepoint [2]
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3 years
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Secondary outcome [3]
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Trough serum functional AAT (fAAT) concentration changes
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Assessment method [3]
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Change in fAAT concentration levels from baseline to end of treatment
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Timepoint [3]
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3 years
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Secondary outcome [4]
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Covariate Analysis: Biometric Values: Weight
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Assessment method [4]
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Assessment of the impact of participant's weight \[in kg\] on the pharmacokinetic profile of SAR447537
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Timepoint [4]
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3 years
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Secondary outcome [5]
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Covariate Analysis: Biometric Values: Height
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Assessment method [5]
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Assessment of the impact of participant's height \[in cm\] on the pharmacokinetic profile of SAR447537
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Timepoint [5]
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3 years
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Secondary outcome [6]
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Covariate Analysis: Biometric Values: Age
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Assessment method [6]
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Assessment of the impact of participant's age \[in years\] on the pharmacokinetic profile of SAR447537
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Timepoint [6]
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3 years
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Secondary outcome [7]
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Covariate Analysis: Biometric Values: Sex
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Assessment method [7]
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Assessment of the impact of participant's sex \[male or female\] on the pharmacokinetic profile of SAR447537
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Timepoint [7]
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3 years
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Secondary outcome [8]
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Anti-drug antibodies
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Assessment method [8]
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Frequency of anti-drug antibodies (ADA) against SAR447537 as well as neutralizing ADA (NAb) against SAR447537
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Timepoint [8]
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3 years
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Eligibility
Key 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
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Minimum age
18
Years
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Maximum age
80
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key 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.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Not applicable
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Single group
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Other design features
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Phase
Phase 2
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
20/06/2024
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
30/09/2028
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Actual
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Sample size
Target
130
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
QLD,SA,VIC
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Recruitment hospital [1]
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Investigational Site Number : 202 - Brisbane
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Recruitment hospital [2]
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Investigational Site Number : 204 - South Brisbane
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Recruitment hospital [3]
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Investigational Site Number : 201 - Adelaide
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Recruitment hospital [4]
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Investigational Site Number : 205 - Frankston
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Recruitment hospital [5]
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Investigational Site Number : 203 - Melbourne
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Recruitment hospital [6]
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Investigational Site Number : 207 - Melbourne
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Recruitment postcode(s) [1]
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4032 - Brisbane
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Recruitment postcode(s) [2]
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4101 - South Brisbane
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Recruitment postcode(s) [3]
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5000 - Adelaide
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Recruitment postcode(s) [4]
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3199 - Frankston
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Recruitment postcode(s) [5]
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3065 - Melbourne
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Recruitment postcode(s) [6]
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3128 - Melbourne
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Recruitment outside Australia
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United States of America
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Alabama
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Coventry
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Sanofi
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
Phase 2 open label extension study to evaluate SAR447537 (INBRX-101) in adults with AATD emphysema
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Trial website
https://clinicaltrials.gov/study/NCT05897424
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Clinical Sciences & Operations
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Address
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Sanofi
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Contact person for public queries
Name
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Trial Transparency email recommended (Toll free for US & Canada)
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Address
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Country
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Phone
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800-633-1610
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Data sharing statement
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT05897424
Download to PDF