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

Description

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

Conditions

Alpha 1-Antitrypsin Deficiency, Emphysema

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Study Overview

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Study Details

Study overview

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

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

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

Condition
Alpha 1-Antitrypsin Deficiency
Intervention / Treatment

-

Contacts and Locations

Birmingham

University of Alabama at Birmingham- Site Number : 105, Birmingham, Alabama, United States, 35233

Phoenix

St. Joseph's Hospital and Medical Center- Site Number : 126, Phoenix, Arizona, United States, 85013

Los Angeles

David Geffen School of Medicine at UCLA- Site Number : 124, Los Angeles, California, United States, 90095-3075

Sacramento

University of California Davis Medical Center, Sacramento, California, United States, 95817-2201

Denver

National Jewish Health Medical Center- Site Number : 123, Denver, Colorado, United States, 80206

Danbury

Nuvance Health Medical Practices, Pulmonary & Sleep Specialists- Site Number : 119, Danbury, Connecticut, United States, 06810-5038

Brandon

Meris Clinical Research-310 Oakfield Dr- Site Number : 115, Brandon, Florida, United States, 33511-5706

Gainesville

University of Florida - Gainesville - 1600 SW Archer Rd- Site Number : 101, Gainesville, Florida, United States, 32610-3003

Indianapolis

Indiana University Health University Hospital- Site Number : 127, Indianapolis, Indiana, United States, 46202

Boston

Brigham and Women's Hospital -75 Francis Street- Site Number : 131, Boston, Massachusetts, United States, 02115-6105

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • 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

Ages Eligible for Study

18 Years to 80 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Sanofi,

Clinical Sciences & Operations, STUDY_DIRECTOR, Sanofi

Study Record Dates

2028-09-30