🇮🇪Ireland
16°C Partly Cloudy · Dublin
Live Updates
--:--:-- IST
Writer Login
Latest
Clinical Trials in the UK / NCT05897424
Active, not recruiting Phase 2

Long-term, Open-label Study of SAR447537 (INBRX-101) in Adults With Alpha-1 Antitrypsin Deficiency Emphysema

NCT05897424 · tracked via the Priya Life Science UK tracker
Sponsor
Sanofi
Phase
Phase 2
Started
2024-06-20
Last updated
2026-04-13

Condition(s) studied

Alpha 1-Antitrypsin DeficiencyEmphysema

Investigational drug(s) / intervention(s)

SAR447537

SAR447537: A1PI, Recombinant, Bivalent Fc Fusion Protein

Study summary

Phase 2 open label extension study to evaluate SAR447537 (INBRX-101) in adults with AATD emphysema

Eligibility

Sex
ALL
Min age
18 Years
Max age
80 Years
Healthy volunteers
No
Inclusion Criteria: 1. Males or females 18-80 years of age, inclusive, at the time of screening 2. Diagnosis of AATD 3. Evidence of emphysema secondary to AATD 4. FEV1 of ≥ 30% predicted at screening and post-bronchodilator FEV1/FVC\<0.7 5. Current non-smoking status Exclusion Criteria: For newly identified participants 1. Receipt of A1PI augmentation therapy within 5 weeks prior to the first dose of study drug 2. Known or suspected allergy to components of SAR447537, A1PI or human IgG 3. Uncontrolled diabetes mellitus despite adequate antidiabetic pharmacologic treatment with a screening HbA1c value ≥9% 4. Received IV immunoglobulins, monoclonal antibodies and/or other biologic therapies within 30 days 5. On waiting list for lung or liver transplant 6. Acute respiratory tract infection or COPD exacerbation within 4 weeks prior to or during screening 7. Evidence of decompensated cirrhosis 8. Active cancers or has a history of malignancy within 5 years prior to screening 9. History of unstable cor pulmonale The above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.

Primary outcome measure(s)

Trial sites (40)

FacilityCityRegionStatus
UAB Lung Health Center- Site Number : 105 Birmingham Alabama
St Joseph's Hospital and Medical Center- Site Number : 126 Phoenix Arizona
David Geffen School of Medicine at UCLA- Site Number : 124 Los Angeles California
University of California Davis Medical Center- Site Number : 110 Sacramento California
National Jewish Medical and Research Center- Site Number : 123 Denver Colorado
Nuvance Health Medical Practices, Pulmonary & Sleep Specialists- Site Number : 119 Danbury Connecticut
University of Florida - Gainesville - 1600 SW Archer Rd- Site Number : 101 Gainesville Florida
Indiana University- Site Number : 127 Indianapolis Indiana
Brigham and Women's Hospital -75 Francis Street- Site Number : 131 Boston Massachusetts
University of Minnesota-420 Delaware Str SE- Site Number : 125 Minneapolis Minnesota
Hannibal Regional Healthcare System-HRMG-Hannibal- Site Number : 111 Hannibal Missouri
Columbia University Irving Medical Center- Site Number : 104 New York New York
Oregon Health and Science University- Site Number : 117 Portland Oregon
Penn State Health Milton S. Hershey Medical Center- Site Number : 122 Hershey Pennsylvania
Temple University Hospital - 3401 N Broad St- Site Number : 130 Philadelphia Pennsylvania
Velocity Clinical Research - Spartanburg - PPDS- Site Number : 120 Spartanburg South Carolina
Houston Methodist Hospital- Site Number : 113 Houston Texas
University of Utah Health Care- Site Number : 106 Salt Lake City Utah
Investigational Site Number : 202 Chermside Queensland
Investigational Site Number : 204 South Brisbane Queensland
Investigational Site Number : 201 North Adelaide South Australia
Investigational Site Number : 207 Box Hill Victoria
Investigational Site Number : 203 Fitzroy Victoria
Investigational Site Number : 205 Frankston Victoria
Investigational Site Number : 701 Hellerup Denmark
Investigational Site Number : 702 Vejle Denmark
Investigational Site Number : 501 Dublin Dublin
Investigational Site Number : 403 Auckland New Zealand
Investigational Site Number : 404 Wellington New Zealand
Investigational Site Number : 801 Warsaw Masovian Voivodeship
Investigational Site Number : 802 Krakow Poland
Investigational Site Number : 901 Santander Cantabria
Investigational Site Number : 902 Madrid Spain
Investigational Site Number : 903 Santiago de Compostela Spain
Investigational Site Number : 601 Gothenburg Sweden
Investigational Site Number : 308 Dundee Angus
Investigational Site Number : 306 Wythenshawe Cheshire
Investigational Site Number : 307 Exeter Devon
Investigational Site Number : 304 Southampton Hampshire
Investigational Site Number : 309 Coventry United Kingdom

More Sanofi trials in the UK

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05897424 on ClinicalTrials.gov ↗ ← All trials in the UK