Clinical Trials in Spain / 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 Spain tracker
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
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)
- Long-term safety and tolerability — 3 years
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).
Trial sites (40)
| Facility | City | Region | Status |
|---|---|---|---|
| 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 Spain
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 Spain