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

Last updated: February 28, 2025
Sponsor: Sanofi
Overall Status: Active - Recruiting

Phase

2

Condition

Emphysema

Treatment

SAR447537

INBRX-101

Clinical Study ID

NCT05897424
INBRX101-01-202
2023-508137-14-00
  • Ages 18-80
  • All Genders

Study Summary

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

Eligibility Criteria

Inclusion

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

Exclusion Criteria:

  1. Receipt of A1PI augmentation therapy within 5 weeks prior to the first dose of studydrug

  2. Known or suspected allergy to components of SAR447537, A1PI or human IgG

  3. Known or suspected diagnosis of type 1 diabetes or diagnosed with uncontrolled type 2 diabetes

  4. Received IV immunoglobulins, monoclonal antibodies and/or other biologic therapieswithin 30 days

  5. On waiting list for lung or liver transplant

  6. Acute respiratory tract infection or COPD exacerbation within 4 weeks prior to orduring 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

  10. Clinically significant congestive heart failure

The above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.

Study Design

Total Participants: 130
Treatment Group(s): 2
Primary Treatment: SAR447537
Phase: 2
Study Start date:
June 20, 2024
Estimated Completion Date:
September 30, 2028

Study Description

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.

Connect with a study center

  • Lung Research Qld

    Chermside, Queensland 4032
    Australia

    Active - Recruiting

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