Study of SAR447537 (INBRX-101) Compared to Plasma-derived A1PI Therapy in Adults With AATD Emphysema
Public ClinicalTrials.gov record NCT05856331. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
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
Study identification
- NCT ID
- NCT05856331
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2
- Lead sponsor
- Sanofi
- Industry
- Enrollment
- 99 participants
Conditions and interventions
Conditions
Interventions
- SAR447537 Drug
- Zemaira Drug
Drug
Eligibility (public fields only)
- Age range
- 18 Years to 80 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Oct 11, 2023
- Primary completion
- Aug 5, 2025
- Completion
- Aug 5, 2025
- Last update posted
- Aug 10, 2025
2023 – 2025
United States locations
- U.S. sites
- 39
- U.S. states
- 16
- U.S. cities
- 21
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| University of Alabama at Birmingham- Site Number : 105 | Birmingham | Alabama | 35233-2110 | — |
| University of Alabama at Birmingham | Birmingham | Alabama | 35249 | — |
| St Joseph's Hospital and Medical Center- Site Number : 126 | Phoenix | Arizona | 85013-4220 | — |
| St Joseph's Hospital and Medical Center | Phoenix | Arizona | 85013-4220 | — |
| David Geffen School of Medicine- Site Number : 124 | Los Angeles | California | 90095-3075 | — |
| David Geffen School of Medicine | Los Angeles | California | 90095 | — |
| UC Davis Comprehensive Cancer Center- Site Number : 110 | Sacramento | California | 95817 | — |
| UC Davis Medical Center | Sacramento | California | 95817 | — |
| National Jewish Medical and Research Center- Site Number : 123 | Denver | Colorado | 80206-2761 | — |
| National Jewish Medical and Research Center | Denver | Colorado | 80206 | — |
| Western Connecticut Medical Group | Danbury | Connecticut | 06810 | — |
| University of Florida College of Medicine- Site Number : 101 | Gainesville | Florida | 32610 | — |
| University of Florida | Gainesville | Florida | 32610 | — |
| Bruce W. Carter Miami VA Medical Center - NAVREF - PPDS- Site Number : 114 | Miami | Florida | 33125-1624 | — |
| University of Miami | Miami | Florida | 33136 | — |
| Pulmonary and Sleep of Tampa Bay- Site Number : 115 | Tampa | Florida | 33607-6316 | — |
| Pulmonary and Sleep of Tampa Bay | Tampa | Florida | 33607 | — |
| Loyola University Medical Center- Site Number : 112 | Maywood | Illinois | 60153 | — |
| Loyola University Medical Center | Maywood | Illinois | 60153 | — |
| Indiana University | Indianapolis | Indiana | 46202-5128 | — |
| M Health Fairview Clinics and Surgery Center - Minneapolis- Site Number : 125 | Minneapolis | Minnesota | 55455-4800 | — |
| M Health Fairview Clinics and Surgery Center - Minneapolis | Minneapolis | Minnesota | 55455-4800 | — |
| Hannibal Regional Healthcare System-HRMG-Hannibal- Site Number : 111 | Hannibal | Missouri | 63401-6890 | — |
| Hannibal Clinic | Hannibal | Missouri | 63401 | — |
| Columbia University Irving Medical Center- Site Number : 104 | New York | New York | 10032 | — |
| Oregon Health and Science University- Site Number : 117 | Portland | Oregon | 97239 | — |
| Oregon Health and Science University | Portland | Oregon | 97239 | — |
| Clinical Research Associates Of Central PA , LLC- Site Number : 128 | DuBois | Pennsylvania | 15801-2277 | — |
| Clinical Research Associates Of Central PA , LLC | DuBois | Pennsylvania | 15801-2277 | — |
| Penn State Health Milton S. Hershey Medical Center- Site Number : 122 | Hershey | Pennsylvania | 17033-2360 | — |
| Penn State Health Milton S. Hershey Medical Center | Hershey | Pennsylvania | 17033 | — |
| Temple University Hospital- Site Number : 130 | Philadelphia | Pennsylvania | 19140 | — |
| Temple University Hospital | Philadelphia | Pennsylvania | 19140 | — |
| Velocity Clinical Research - Spartanburg - PPDS- Site Number : 120 | Spartanburg | South Carolina | 29303-4225 | — |
| Velocity Clinical Research - Spartanburg - PPDS | Spartanburg | South Carolina | 29303 | — |
| Houston Methodist Hospital- Site Number : 113 | Houston | Texas | 77030 | — |
| Houston Methodist Hospital | Houston | Texas | 77030 | — |
| University of Utah Health | Salt Lake City | Utah | 84108 | — |
| University of Utah Health Care- Site Number : 106 | Salt Lake City | Utah | 84132-0001 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 26 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT05856331, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Aug 10, 2025 · Synced Jul 22, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete protocol, eligibility criteria, and contact information for NCT05856331 live on ClinicalTrials.gov.