Long-term, Open-label Study of SAR447537 (INBRX-101) in Adults With Alpha-1 Antitrypsin Deficiency Emphysema
- Registration Number
- NCT05897424
- Lead Sponsor
- Sanofi
- Brief Summary
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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 130
- 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
- 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
- Known or suspected diagnosis of type 1 diabetes or diagnosed with uncontrolled type 2 diabetes
- Received IV immunoglobulins, monoclonal antibodies and/or other biologic therapies within 30 days
- On waiting list for lung or liver transplant
- 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
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description SAR447537 (INBRX-101) SAR447537 A1PI, Recombinant, Bivalent Fc Fusion Protein, in a solution for intravenous injection
- Primary Outcome Measures
Name Time Method Long-term safety and tolerability 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).
- Secondary Outcome Measures
Name Time Method Change in lung density by quantitative computerized tomography (CT) 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).
Trough SAR447537 concentration changes 3 years Change in SAR447537 concentration levels from baseline to end of treatment
Trough serum functional AAT (fAAT) concentration changes 3 years Change in fAAT concentration levels from baseline to end of treatment
Covariate Analysis: Biometric Values: Weight 3 years Assessment of the impact of participant's weight \[in kg\] on the pharmacokinetic profile of SAR447537
Covariate Analysis: Biometric Values: Height 3 years Assessment of the impact of participant's height \[in cm\] on the pharmacokinetic profile of SAR447537
Covariate Analysis: Biometric Values: Age 3 years Assessment of the impact of participant's age \[in years\] on the pharmacokinetic profile of SAR447537
Covariate Analysis: Biometric Values: Sex 3 years Assessment of the impact of participant's sex \[male or female\] on the pharmacokinetic profile of SAR447537
Anti-drug antibodies 3 years Frequency of anti-drug antibodies (ADA) against SAR447537 as well as neutralizing ADA (NAb) against SAR447537
Trial Locations
- Locations (41)
University of Alabama at Birmingham- Site Number : 105
🇺🇸Birmingham, Alabama, United States
St. Joseph's Hospital and Medical Center- Site Number : 126
🇺🇸Phoenix, Arizona, United States
David Geffen School of Medicine at UCLA- Site Number : 124
🇺🇸Los Angeles, California, United States
University of California Davis Medical Center
🇺🇸Sacramento, California, United States
National Jewish Health Medical Center- Site Number : 123
🇺🇸Denver, Colorado, United States
Nuvance Health Medical Practices, Pulmonary & Sleep Specialists- Site Number : 119
🇺🇸Danbury, Connecticut, United States
Meris Clinical Research-310 Oakfield Dr- Site Number : 115
🇺🇸Brandon, Florida, United States
University of Florida - Gainesville - 1600 SW Archer Rd- Site Number : 101
🇺🇸Gainesville, Florida, United States
Indiana University Health University Hospital- Site Number : 127
🇺🇸Indianapolis, Indiana, United States
Brigham and Women's Hospital -75 Francis Street- Site Number : 131
🇺🇸Boston, Massachusetts, United States
University of Minnesota-420 Delaware Str SE- Site Number : 125
🇺🇸Minneapolis, Minnesota, United States
Hannibal Regional Healthcare System-HRMG-Hannibal- Site Number : 111
🇺🇸Hannibal, Missouri, United States
Columbia University Irving Medical Center- Site Number : 104
🇺🇸New York, New York, United States
Oregon Health and Science University- Site Number : 117
🇺🇸Portland, Oregon, United States
Penn State Health Milton S. Hershey Medical Center- Site Number : 122
🇺🇸Hershey, Pennsylvania, United States
Temple University Hospital - 3401 N Broad St- Site Number : 130
🇺🇸Philadelphia, Pennsylvania, United States
Investigational Site Number : 204
🇦🇺South Brisbane, Queensland, Australia
Velocity Clinical Research - Spartanburg - PPDS- Site Number : 120
🇺🇸Spartanburg, South Carolina, United States
Investigational Site Number : 202
🇦🇺Brisbane, Queensland, Australia
Houston Methodist Hospital- Site Number : 113
🇺🇸Houston, Texas, United States
University of Utah Health Care- Site Number : 106
🇺🇸Salt Lake City, Utah, United States
Investigational Site Number : 201
🇦🇺Adelaide, South Australia, Australia
Investigational Site Number : 205
🇦🇺Frankston, Victoria, Australia
Investigational Site Number : 203
🇦🇺Melbourne, Victoria, Australia
Investigational Site Number : 207
🇦🇺Melbourne, Victoria, Australia
Investigational Site Number : 701
🇩🇰Hellerup, Denmark
Investigational Site Number : 702
🇩🇰Vejle, Denmark
Investigational Site Number : 501
🇮🇪Dublin 9, Dublin, Ireland
Investigational Site Number : 403
🇳🇿Auckland, New Zealand
Investigational Site Number : 802
🇵🇱Krakow, Malopolskie, Poland
Investigational Site Number : 601
🇸🇪Gothenburg, Sweden
Investigational Site Number : 308
🇬🇧Dundee, Angus, United Kingdom
Investigational Site Number : 404
🇳🇿Wellington, New Zealand
Investigational Site Number : 903
🇪🇸Santiago de Compostela, A Coruña [La Coruña], Spain
Investigational Site Number : 901
🇪🇸Santander, Cantabria, Spain
Investigational Site Number : 902
🇪🇸Madrid, Spain
Investigational Site Number : 307
🇬🇧Exeter, Devon, United Kingdom
Investigational Site Number : 304
🇬🇧Southampton, Hampshire, United Kingdom
Investigational Site Number : 309
🇬🇧Coventry, United Kingdom
Investigational Site Number: 306
🇬🇧Manchester, United Kingdom
Investigational Site Number : 306
🇬🇧Wythenshawe, United Kingdom