Summary

Eligibility
for people ages 18-80 (full criteria)
Location
at UC Davis UCLA
Dates
study started
completion around
Principal Investigator
by Igor Barjaktarevic, MD, PhD (ucla)
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 University of California Health

Details

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