Study of SAR447537 (INBRX-101) Compared to Plasma-derived A1PI Therapy in Adults With AATD Emphysema
ELEVAATE
Phase 2, Double-Blind, Randomized, Active-Control, Parallel Group Study to Assess the Pharmacokinetics, Pharmacodynamics, Immunogenicity, and Safety of SAR447537 (INBRX-101) Compared to Plasma-Derived Alpha1-Proteinase Inhibitor (A1PI) Augmentation Therapy in Adults With Alpha-1 Antitrypsin Deficiency (AATD) Emphysema
2 other identifiers
interventional
99
8 countries
65
Brief Summary
Phase 2 study to compare SAR447537 (INBRX-101) to plasma derived A1PI therapy in adults with AATD emphysema
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Oct 2023
65 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 28, 2023
CompletedFirst Posted
Study publicly available on registry
May 12, 2023
CompletedStudy Start
First participant enrolled
October 12, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 6, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
August 6, 2025
CompletedAugust 11, 2025
August 1, 2025
1.8 years
March 28, 2023
August 8, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Serum functional AAT (fAAT) levels at steady-state
To assess the mean change in average fAAT concentration as measured by anti-neutrophil elastase capacity \[ANEC\] from baseline to average serum trough fAAT concentration at steady-state (Ctrough,ss) in participants treated with SAR447537 compared to A1PI
32 Weeks
Secondary Outcomes (10)
fAAT Concentration changes
32 Weeks
Days with fAAT above the lower limit of the normal range
32 weeks
Incidence of TEAEs
32 Weeks
Anti-drug antibodies
32 Weeks
Population Pharmacokinetics: Clearance
32 Weeks
- +5 more secondary outcomes
Study Arms (3)
SAR447537 (INBRX-101) Q3W
EXPERIMENTALIV every 3-weeks (Q3W) and placebo (normal saline)
SAR447537 (INBRX-101) Q4W
EXPERIMENTALIV every 4-weeks (Q4W) and placebo (normal saline)
Zemaira (A1PI)
ACTIVE COMPARATOR60 mg/kg IV once weekly (QW) and placebo (normal saline)
Interventions
Eligibility Criteria
You may qualify if:
- 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% and ≤ 80% predicted at screening
- Current non-smoking status.
You may not qualify if:
- Receipt of A1PI augmentation therapy within 5 weeks prior to the first dose of study drug
- Known or suspected allergy to components of SAR447537 (INBRX-101), A1PI or human IgG
- Known selective or severe Immunoglobulin A (IgA) deficiency
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Sanofilead
Study Sites (65)
University of Alabama at Birmingham- Site Number : 105
Birmingham, Alabama, 35233-2110, United States
University of Alabama at Birmingham
Birmingham, Alabama, 35249, United States
St Joseph's Hospital and Medical Center- Site Number : 126
Phoenix, Arizona, 85013-4220, United States
St Joseph's Hospital and Medical Center
Phoenix, Arizona, 85013-4220, United States
David Geffen School of Medicine- Site Number : 124
Los Angeles, California, 90095-3075, United States
David Geffen School of Medicine
Los Angeles, California, 90095, United States
UC Davis Comprehensive Cancer Center- Site Number : 110
Sacramento, California, 95817, United States
UC Davis Medical Center
Sacramento, California, 95817, United States
National Jewish Medical and Research Center- Site Number : 123
Denver, Colorado, 80206-2761, United States
National Jewish Medical and Research Center
Denver, Colorado, 80206, United States
Western Connecticut Medical Group
Danbury, Connecticut, 06810, United States
University of Florida College of Medicine- Site Number : 101
Gainesville, Florida, 32610, United States
University of Florida
Gainesville, Florida, 32610, United States
Bruce W. Carter Miami VA Medical Center - NAVREF - PPDS- Site Number : 114
Miami, Florida, 33125-1624, United States
University of Miami
Miami, Florida, 33136, United States
Pulmonary and Sleep of Tampa Bay- Site Number : 115
Tampa, Florida, 33607-6316, United States
Pulmonary and Sleep of Tampa Bay
Tampa, Florida, 33607, United States
Loyola University Medical Center- Site Number : 112
Maywood, Illinois, 60153, United States
Loyola University Medical Center
Maywood, Illinois, 60153, United States
Indiana University
Indianapolis, Indiana, 46202-5128, United States
M Health Fairview Clinics and Surgery Center - Minneapolis- Site Number : 125
Minneapolis, Minnesota, 55455-4800, United States
M Health Fairview Clinics and Surgery Center - Minneapolis
Minneapolis, Minnesota, 55455-4800, United States
Hannibal Regional Healthcare System-HRMG-Hannibal- Site Number : 111
Hannibal, Missouri, 63401-6890, United States
Hannibal Clinic
Hannibal, Missouri, 63401, United States
Columbia University Irving Medical Center- Site Number : 104
New York, New York, 10032, United States
Oregon Health and Science University- Site Number : 117
Portland, Oregon, 97239, United States
Oregon Health and Science University
Portland, Oregon, 97239, United States
Clinical Research Associates Of Central PA , LLC- Site Number : 128
DuBois, Pennsylvania, 15801-2277, United States
Clinical Research Associates Of Central PA , LLC
DuBois, Pennsylvania, 15801-2277, United States
Penn State Health Milton S. Hershey Medical Center- Site Number : 122
Hershey, Pennsylvania, 17033-2360, United States
Penn State Health Milton S. Hershey Medical Center
Hershey, Pennsylvania, 17033, United States
Temple University Hospital- Site Number : 130
Philadelphia, Pennsylvania, 19140, United States
Temple University Hospital
Philadelphia, Pennsylvania, 19140, United States
Velocity Clinical Research - Spartanburg - PPDS- Site Number : 120
Spartanburg, South Carolina, 29303-4225, United States
Velocity Clinical Research - Spartanburg - PPDS
Spartanburg, South Carolina, 29303, United States
Houston Methodist Hospital- Site Number : 113
Houston, Texas, 77030, United States
Houston Methodist Hospital
Houston, Texas, 77030, United States
University of Utah Health
Salt Lake City, Utah, 84108, United States
University of Utah Health Care- Site Number : 106
Salt Lake City, Utah, 84132-0001, United States
Donna McIntyre
Brisbane, Queensland, 2650, Australia
Queensland Centre for Pulmonary Transplantation
Chermside, Queensland, Australia
Royal Adelaide Hospital
North Adelaide, South Australia, 5065, Australia
Eastern Health Clinical School
Box Hill, Victoria, 3128, Australia
Investigational Site Number : 203
Fitzroy, Victoria, 3065, Australia
St Vincent Hospital Melbourne
Fitzroy, Victoria, Australia
Frankston Hospital
Frankston, Victoria, 3199, Australia
Institute for Respiratory Health
Nedlands, Western Australia, 6009, Australia
Investigational Site Number : 206
Nedlands, Western Australia, 6009, Australia
Investigational Site Number : 201
Adelaide, 5000, Australia
Investigational Site Number : 202
Chermside, 4032, Australia
Investigational Site Number : 701
Hellerup, 2900, Denmark
Investigational Site Number : 702
Vejle, 7100, Denmark
NZRSI
Greenlane, Auckland, 1051, New Zealand
Investigational Site Number : 403
Auckland, 1051, New Zealand
Investigational Site Number : 404
Wellington, 6021, New Zealand
P3 Research
Wellington, 6021, New Zealand
Investigational Site Number : 801
Warsaw, Masovian Voivodeship, 01-138, Poland
Investigational Site Number : 802
Krakow, 30-688, Poland
Investigational Site Number : 901
Santander, Cantabria, 39008, Spain
Investigational Site Number : 903
Santiago de Compostela, La Coruña, 15706, Spain
Investigational Site Number : 601
Gothenburg, 413 46, Sweden
Ninewells Hospital - PPDS
Dundee, Angus, DD1 9SY, United Kingdom
Investigational Site Number : 306
Wythenshawe, Cheshire West And Chester, M23 9QZ, United Kingdom
Medicines Evaluation Unit
Manchester, Cheshire, M23 9QZ, United Kingdom
Investigational Site Number : 302
Birmingham, Warwickshire, B15 2WB, United Kingdom
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Clinical Sciences & Operations
Sanofi
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 28, 2023
First Posted
May 12, 2023
Study Start
October 12, 2023
Primary Completion
August 6, 2025
Study Completion
August 6, 2025
Last Updated
August 11, 2025
Record last verified: 2025-08
Data Sharing
- IPD Sharing
- Will share
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