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NCT05897424 · ClinicalTrials.gov registry record · Phase 2
Long-term, Open-label Study of SAR447537 (INBRX-101) in Adults With Alpha-1 Antitrypsin Deficiency Emphysema
A Phase 2 study of Emphysema and Alpha-1 Antitrypsin Deficiency, sponsored by Sanofi.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 185
- Enrollment target
- 20
- Study locations
NCT05897424: Recruiting Phase 2 study of Emphysema and Alpha-1 Antitrypsin Deficiency, sponsored by Sanofi.
NCT05897424 is a Phase 2 study of Emphysema and Alpha-1 Antitrypsin Deficiency that is actively recruiting participants, run by Sanofi. The registered enrollment target is 185 participants, below the 3,796-participant average among 25 other Emphysema trials with a reported enrollment target (95% lower). The trial reports 20 study locations across 17 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05897424, a Phase 2 study of Emphysema and Alpha-1 Antitrypsin Deficiency, is actively recruiting participants, sponsored by Sanofi.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 185 participants
- Enrollment target
- 20
- Study locations
Study Summary
Phase 2 open label extension study to evaluate SAR447537 (INBRX-101) in adults with AATD emphysema
Primary Outcome
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).
Conditions Studied
Interventions
- DRUG SAR447537
Study Locations (20)
California
- David Geffen School of Medicine at UCLA- Site Number : 124 - Los Angeles
- University of California Davis Medical Center- Site Number : 110 - Sacramento
Pennsylvania
- Penn State Health Milton S. Hershey Medical Center- Site Number : 122 - Hershey
- Temple University Hospital - 3401 N Broad St- Site Number : 130 - Philadelphia
Queensland
- Investigational Site Number : 202 - Chermside
- Investigational Site Number : 204 - South Brisbane
Alabama
- UAB Lung Health Center- Site Number : 105 - Birmingham
Arizona
- St Joseph's Hospital and Medical Center- Site Number : 126 - Phoenix
Colorado
- National Jewish Medical and Research Center- Site Number : 123 - Denver
Connecticut
- Nuvance Health Medical Practices, Pulmonary & Sleep Specialists- Site Number : 119 - Danbury
Florida
- University of Florida - Gainesville - 1600 SW Archer Rd- Site Number : 101 - Gainesville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 185 participants |
| Start Date | 2024-06-20 |
| Est. Completion | 2028-09-30 |
| Phase | Phase 2 |
What NCT05897424 shows while recruiting
NCT05897424 is an interventional study that assigns participants to a tested intervention. The registered 185 participants enrollment target is mid-sized for trials with a published cap, below the 3,796-participant average among 25 other Emphysema trials with a reported enrollment target (95% lower).
The record links to 2 conditions, with Emphysema appearing as the primary indexed condition, and to 1 intervention - of which SAR447537 is the first listed.
NCT05897424 names 20 study sites across 17 states, led by California, Pennsylvania, Queensland.
Frequently Asked Questions
What is clinical trial NCT05897424 about?
NCT05897424 is a clinical study titled "Long-term, Open-label Study of SAR447537 (INBRX-101) in Adults With Alpha-1 Antitrypsin Deficiency Emphysema". Phase 2 open label extension study to evaluate SAR447537 (INBRX-101) in adults with AATD emphysema
What is the current status of trial NCT05897424?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 185 participants. The study started on 2024-06-20. Estimated completion is 2028-09-30.
What conditions does trial NCT05897424 study?
This clinical trial studies the following conditions: Emphysema, Alpha-1 Antitrypsin Deficiency.
What interventions are being tested in trial NCT05897424?
The interventions under investigation include: SAR447537 (DRUG).
Who is sponsoring clinical trial NCT05897424?
This trial is sponsored by Sanofi, which has 713 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05897424 being conducted?
This trial has 20 study locations across Alabama, Arizona, California, Colorado, Connecticut. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Emphysema
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05897424's enrollment target sits among peer trials
185 11th of 25 higher than 15 of 25 other Emphysema trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Emphysema trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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