Summary

Eligibility
for people ages 18-80 (full criteria)
Location
at Los Angeles, California and other locations
Dates
study started
completion around
Principal Investigator
by Igor Barjaktarevic, MD, PhD
Headshot of Igor Barjaktarevic
Igor Barjaktarevic

Description

Summary

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

Official Title

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

Details

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.

Keywords

Alpha 1-Antitrypsin Deficiency, Emphysema, AATD, INBRX-101, AAT, SAR447537, Pulmonary Emphysema, SAR447537 (INBRX-101)

Eligibility

You can join if…

Open to people ages 18-80

  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

You CAN'T join if...

  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. 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 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
  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.

Locations

  • David Geffen School of Medicine at UCLA- Site Number : 124 accepting new patients
    Los Angeles California 90095-3075 United States
  • University of California Davis Medical Center accepting new patients
    Sacramento California 95817-2201 United States

Lead Scientist at UCLA

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Sanofi
Links
Sign up for this study
ID
NCT05897424
Phase
Phase 2 research study
Study Type
Interventional
Participants
Expecting 130 study participants
Last Updated