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

Last updated: May 14, 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

  • Investigational Site Number : 202

    Brisbane, Queensland 4032
    Australia

    Active - Recruiting

  • Lung Research Qld

    Chermside, Queensland 4032
    Australia

    Site Not Available

  • Investigational Site Number : 204

    South Brisbane, Queensland 4101
    Australia

    Active - Recruiting

  • Investigational Site Number : 201

    Adelaide, South Australia 5000
    Australia

    Active - Recruiting

  • Investigational Site Number : 205

    Frankston, Victoria 3199
    Australia

    Active - Recruiting

  • Investigational Site Number : 203

    Melbourne, Victoria 3065
    Australia

    Active - Recruiting

  • Investigational Site Number : 207

    Melbourne, Victoria 3128
    Australia

    Active - Recruiting

  • Investigational Site Number : 701

    Hellerup, 2900
    Denmark

    Active - Recruiting

  • Investigational Site Number : 702

    Vejle, 7100
    Denmark

    Active - Recruiting

  • Investigational Site Number : 501

    Dublin 9, Dublin D09 XR63
    Ireland

    Active - Recruiting

  • Investigational Site Number : 403

    Auckland, 1051
    New Zealand

    Active - Recruiting

  • Investigational Site Number : 404

    Wellington, 6021
    New Zealand

    Active - Recruiting

  • Investigational Site Number : 802

    Krakow, Malopolskie 31-501
    Poland

    Active - Recruiting

  • Investigational Site Number : 903

    Santiago de Compostela, A Coruña [La Coruña] 15706
    Spain

    Active - Recruiting

  • Investigational Site Number : 901

    Santander, Cantabria 39008
    Spain

    Active - Recruiting

  • Investigational Site Number : 902

    Madrid, 28040
    Spain

    Active - Recruiting

  • Investigational Site Number : 601

    Gothenburg, 413 45
    Sweden

    Active - Recruiting

  • Investigational Site Number : 308

    Dundee, Angus DD1 9SY
    United Kingdom

    Active - Recruiting

  • Investigational Site Number : 307

    Exeter, Devon EX2 5DW
    United Kingdom

    Active - Recruiting

  • Investigational Site Number : 304

    Southampton, Hampshire SO16 6YD
    United Kingdom

    Active - Recruiting

  • Investigational Site Number : 309

    Coventry, CV2 2DX
    United Kingdom

    Active - Recruiting

  • Investigational Site Number: 306

    Manchester, M23 9QZ
    United Kingdom

    Active - Recruiting

  • Investigational Site Number : 306

    Wythenshawe, M23 9QZ
    United Kingdom

    Active - Recruiting

  • University of Alabama at Birmingham- Site Number : 105

    Birmingham, Alabama 35233
    United States

    Active - Recruiting

  • St. Joseph's Hospital and Medical Center- Site Number : 126

    Phoenix, Arizona 85013
    United States

    Active - Recruiting

  • David Geffen School of Medicine at UCLA- Site Number : 124

    Los Angeles, California 90095-3075
    United States

    Active - Recruiting

  • University of California Davis Medical Center

    Sacramento, California 95817-2201
    United States

    Active - Recruiting

  • National Jewish Health Medical Center- Site Number : 123

    Denver, Colorado 80206
    United States

    Active - Recruiting

  • Nuvance Health Medical Practices, Pulmonary & Sleep Specialists- Site Number : 119

    Danbury, Connecticut 06810-5038
    United States

    Active - Recruiting

  • Meris Clinical Research-310 Oakfield Dr- Site Number : 115

    Brandon, Florida 33511-5706
    United States

    Active - Recruiting

  • University of Florida - Gainesville - 1600 SW Archer Rd- Site Number : 101

    Gainesville, Florida 32610-3003
    United States

    Active - Recruiting

  • Indiana University Health University Hospital- Site Number : 127

    Indianapolis, Indiana 46202
    United States

    Active - Recruiting

  • Brigham and Women's Hospital -75 Francis Street- Site Number : 131

    Boston, Massachusetts 02115-6105
    United States

    Active - Recruiting

  • University of Minnesota-420 Delaware Str SE- Site Number : 125

    Minneapolis, Minnesota 55455-0341
    United States

    Active - Recruiting

  • Hannibal Regional Healthcare System-HRMG-Hannibal- Site Number : 111

    Hannibal, Missouri 63401-6890
    United States

    Active - Recruiting

  • Columbia University Irving Medical Center- Site Number : 104

    New York, New York 10032-3729
    United States

    Active - Recruiting

  • Oregon Health and Science University- Site Number : 117

    Portland, Oregon 97239
    United States

    Active - Recruiting

  • Penn State Health Milton S. Hershey Medical Center- Site Number : 122

    Hershey, Pennsylvania 17033-2360
    United States

    Active - Recruiting

  • Temple University Hospital - 3401 N Broad St- Site Number : 130

    Philadelphia, Pennsylvania 19140-5103
    United States

    Active - Recruiting

  • Velocity Clinical Research - Spartanburg - PPDS- Site Number : 120

    Spartanburg, South Carolina 29303-4225
    United States

    Active - Recruiting

  • Houston Methodist Hospital- Site Number : 113

    Houston, Texas 77030
    United States

    Active - Recruiting

  • University of Utah Health Care- Site Number : 106

    Salt Lake City, Utah 84132-0001
    United States

    Active - Recruiting

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