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
Status: Completed
Location: See all (65) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY
Phase 2 study to compare SAR447537 (INBRX-101) to plasma derived A1PI therapy in adults with AATD emphysema
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: f
View:
• 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.
Locations
United States
Alabama
University of Alabama at Birmingham
Birmingham
University of Alabama at Birmingham- Site Number : 105
Birmingham
Arizona
St Joseph's Hospital and Medical Center
Phoenix
St Joseph's Hospital and Medical Center- Site Number : 126
Phoenix
California
David Geffen School of Medicine
Los Angeles
David Geffen School of Medicine- Site Number : 124
Los Angeles
UC Davis Comprehensive Cancer Center- Site Number : 110
Sacramento
UC Davis Medical Center
Sacramento
Colorado
National Jewish Medical and Research Center
Denver
National Jewish Medical and Research Center- Site Number : 123
Denver
Connecticut
Western Connecticut Medical Group
Danbury
Florida
University of Florida
Gainesville
University of Florida College of Medicine- Site Number : 101
Gainesville
Bruce W. Carter Miami VA Medical Center - NAVREF - PPDS- Site Number : 114
Miami
University of Miami
Miami
Pulmonary and Sleep of Tampa Bay
Tampa
Pulmonary and Sleep of Tampa Bay- Site Number : 115
Tampa
Illinois
Loyola University Medical Center
Maywood
Loyola University Medical Center- Site Number : 112
Maywood
Indiana
Indiana University
Indianapolis
Minnesota
M Health Fairview Clinics and Surgery Center - Minneapolis
Minneapolis
M Health Fairview Clinics and Surgery Center - Minneapolis- Site Number : 125
Minneapolis
Missouri
Hannibal Clinic
Hannibal
Hannibal Regional Healthcare System-HRMG-Hannibal- Site Number : 111
Hannibal
New York
Columbia University Irving Medical Center- Site Number : 104
New York
Oregon
Oregon Health and Science University
Portland
Oregon Health and Science University- Site Number : 117
Portland
Pennsylvania
Clinical Research Associates Of Central PA , LLC
Dubois
Clinical Research Associates Of Central PA , LLC- Site Number : 128
Dubois
Penn State Health Milton S. Hershey Medical Center
Hershey
Penn State Health Milton S. Hershey Medical Center- Site Number : 122
Hershey
Temple University Hospital
Philadelphia
Temple University Hospital- Site Number : 130
Philadelphia
South Carolina
Velocity Clinical Research - Spartanburg - PPDS
Spartanburg
Velocity Clinical Research - Spartanburg - PPDS- Site Number : 120
Spartanburg
Texas
Houston Methodist Hospital
Houston
Houston Methodist Hospital- Site Number : 113
Houston
Utah
University of Utah Health
Salt Lake City
University of Utah Health Care- Site Number : 106
Salt Lake City
Other Locations
Australia
Investigational Site Number : 201
Adelaide
Eastern Health Clinical School
Box Hill
Donna McIntyre
Brisbane
Investigational Site Number : 202
Chermside
Queensland Centre for Pulmonary Transplantation
Chermside
Investigational Site Number : 203
Fitzroy
St Vincent Hospital Melbourne
Fitzroy
Frankston Hospital
Frankston
Institute for Respiratory Health
Nedlands
Investigational Site Number : 206
Nedlands
Royal Adelaide Hospital
North Adelaide
Denmark
Investigational Site Number : 701
Hellerup
Investigational Site Number : 702
Vejle
New Zealand
Investigational Site Number : 403
Auckland
NZRSI
Greenlane
Investigational Site Number : 404
Wellington
P3 Research
Wellington
Poland
Investigational Site Number : 802
Krakow
Investigational Site Number : 801
Warsaw
Spain
Investigational Site Number : 901
Santander
Investigational Site Number : 903
Santiago De Compostela
Sweden
Investigational Site Number : 601
Gothenburg
United Kingdom
Investigational Site Number : 302
Birmingham
Ninewells Hospital - PPDS
Dundee
Medicines Evaluation Unit
Manchester
Investigational Site Number : 306
Wythenshawe
Time Frame
Start Date: 2023-10-12
Completion Date: 2025-08-06
Participants
Target number of participants: 99
Treatments
Experimental: SAR447537 (INBRX-101) Q3W
IV every 3-weeks (Q3W) and placebo (normal saline)
Experimental: SAR447537 (INBRX-101) Q4W
IV every 4-weeks (Q4W) and placebo (normal saline)
Active_comparator: Zemaira (A1PI)
60 mg/kg IV once weekly (QW) and placebo (normal saline)
Related Therapeutic Areas
Sponsors
Leads: Sanofi