Active Not Recruiting INTERVENTIONAL NCT05897424

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

A Phase 2, Single Arm, Open Label Extension Study, Evaluating the Long-Term Safety and Clinical Efficacy of SAR447537 (INBRX-101) in Adults With Alpha-1 Antitrypsin Deficiency (AATD) Emphysema

Sponsor: Sanofi

Conditions Alpha 1-Antitrypsin Deficiency Emphysema

Interventions SAR447537

Updated 12 times since 2023 Last updated: Apr 8, 2026 Started: Jun 20, 2024 Primary completion: Jun 30, 2028 Completion: Sep 30, 2028

This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

This observational or N/A phase trial investigates Alpha 1-Antitrypsin Deficiency and Emphysema and is currently ongoing. Sanofi leads this study, which shows 12 recorded versions since 2024 — indicating substantial longitudinal coverage. The change history captured here reflects the iterative nature of clinical trial conduct.

Study Description(click to expand)

This is a Phase 2, Single Arm, Open Label Extension Study, Evaluating the Long-Term Safety and Clinical Efficacy of SAR447537 (INBRX-101) in Adults With Alpha-1 Antitrypsin Deficiency (AATD) Emphysema.

Status Flow

Change History

12 versions recorded

Apr 13, 2026 — Present [daily]

Active Not Recruiting

Status: Recruiting → Active Not Recruiting · Phase: PHASE2 → None
Jan 2026 — Present [monthly]

Recruiting PHASE2
Nov 2025 — Present [monthly]

Recruiting PHASE2
Sep 2025 — Nov 2025 [monthly]

Recruiting PHASE2
Aug 2025 — Sep 2025 [monthly]

Recruiting PHASE2

▶ Show 7 earlier versions

Jun 2025 — Aug 2025 [monthly]

Recruiting PHASE2
Apr 2025 — Jun 2025 [monthly]

Recruiting PHASE2
Sep 2024 — Apr 2025 [monthly]

Recruiting PHASE2
Aug 2024 — Sep 2024 [monthly]

Recruiting PHASE2

Status: Not Yet Recruiting → Recruiting
Jul 2024 — Aug 2024 [monthly]

Not Yet Recruiting PHASE2
Apr 2024 — Jul 2024 [monthly]

Not Yet Recruiting PHASE2
Jul 2023 — Apr 2024 [monthly]

Not Yet Recruiting PHASE2

First recorded

Eligibility Summary

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

Contact Information

Sponsor contact:

Sanofi

Data source: ClinicalTrials.gov

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations

Auckland, New Zealand , Birmingham, United States , Boston, United States , Box Hill, Australia , Chermside, Australia , Coventry, United Kingdom , Danbury, United States , Denver, United States , Dublin, Ireland , Dundee, United Kingdom and 30 more locations