Phase 2 open label extension study to evaluate SAR447537 (INBRX-101) in adults with AATD emphysema
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
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
185
A1PI, Recombinant, Bivalent Fc Fusion Protein
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).
Time frame: 3 years
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).
Time frame: 3 years
Trough SAR447537 concentration changes
Change in SAR447537 concentration levels from baseline to end of treatment
Time frame: 3 years
Trough serum functional AAT (fAAT) concentration changes
Change in fAAT concentration levels from baseline to end of treatment
Time frame: 3 years
Covariate Analysis: Biometric Values: Weight
Assessment of the impact of participant's weight \[in kg\] on the pharmacokinetic profile of SAR447537
Time frame: 3 years
Covariate Analysis: Biometric Values: Height
Assessment of the impact of participant's height \[in cm\] on the pharmacokinetic profile of SAR447537
Time frame: 3 years
Covariate Analysis: Biometric Values: Age
Assessment of the impact of participant's age \[in years\] on the pharmacokinetic profile of SAR447537
Trial Transparency email recommended (Toll free for US & Canada)
CONTACT
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UAB Lung Health Center- Site Number : 105
Birmingham, Alabama, United States
ACTIVE_NOT_RECRUITINGSt Joseph's Hospital and Medical Center- Site Number : 126
Phoenix, Arizona, United States
ACTIVE_NOT_RECRUITINGDavid Geffen School of Medicine at UCLA- Site Number : 124
Los Angeles, California, United States
RECRUITINGUniversity of California Davis Medical Center- Site Number : 110
Sacramento, California, United States
ACTIVE_NOT_RECRUITINGNational Jewish Medical and Research Center- Site Number : 123
Denver, Colorado, United States
ACTIVE_NOT_RECRUITINGNuvance Health Medical Practices, Pulmonary & Sleep Specialists- Site Number : 119
Danbury, Connecticut, United States
ACTIVE_NOT_RECRUITINGUniversity of Florida - Gainesville - 1600 SW Archer Rd- Site Number : 101
Gainesville, Florida, United States
ACTIVE_NOT_RECRUITINGIndiana University- Site Number : 127
Indianapolis, Indiana, United States
ACTIVE_NOT_RECRUITINGBrigham and Women's Hospital -75 Francis Street- Site Number : 131
Boston, Massachusetts, United States
ACTIVE_NOT_RECRUITINGUniversity of Minnesota-420 Delaware Str SE- Site Number : 125
Minneapolis, Minnesota, United States
ACTIVE_NOT_RECRUITING...and 30 more locations
Time frame: 3 years
Covariate Analysis: Biometric Values: Sex
Assessment of the impact of participant's sex \[male or female\] on the pharmacokinetic profile of SAR447537
Time frame: 3 years
Anti-drug antibodies
Frequency of anti-drug antibodies (ADA) against SAR447537 as well as neutralizing ADA (NAb) against SAR447537
Time frame: 3 years