RECRUITING

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

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Conditions

Alpha 1-Antitrypsin DeficiencyEmphysemaAATDINBRX-101AATSAR447537

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Quick Facts

Study Start:2024-06-20
Study Completion:2028-09-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05897424

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.

Ages Eligible for Study:18 Years to 80 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Males or females 18-80 years of age, inclusive, at the time of screening
  2. 2. Diagnosis of AATD
  3. 3. Evidence of emphysema secondary to AATD
  4. 4. FEV1 of ≥ 30% predicted at screening and post-bronchodilator FEV1/FVC\<0.7
  5. 5. Current non-smoking status
  1. 1. Receipt of A1PI augmentation therapy within 5 weeks prior to the first dose of study drug
  2. 2. Known or suspected allergy to components of SAR447537, A1PI or human IgG
  3. 3. Known or suspected diagnosis of type 1 diabetes or diagnosed with uncontrolled type 2 diabetes
  4. 4. Received IV immunoglobulins, monoclonal antibodies and/or other biologic therapies within 30 days
  5. 5. On waiting list for lung or liver transplant
  6. 6. Acute respiratory tract infection or COPD exacerbation within 4 weeks prior to or during screening
  7. 7. Evidence of decompensated cirrhosis
  8. 8. Active cancers or has a history of malignancy within 5 years prior to screening
  9. 9. History of unstable cor pulmonale
  10. 10. Clinically significant congestive heart failure

Contacts and Locations

Study Contact

Trial Transparency email recommended (Toll free for US & Canada)
CONTACT
800-633-1610
Contact-us@sanofi.com

Principal Investigator

Clinical Sciences & Operations
STUDY_DIRECTOR
Sanofi

Study Locations (Sites)

University of Alabama at Birmingham- Site Number : 105
Birmingham, Alabama, 35233
United States
St. Joseph's Hospital and Medical Center- Site Number : 126
Phoenix, Arizona, 85013
United States
David Geffen School of Medicine at UCLA- Site Number : 124
Los Angeles, California, 90095-3075
United States
University of California Davis Medical Center
Sacramento, California, 95817-2201
United States
National Jewish Health Medical Center- Site Number : 123
Denver, Colorado, 80206
United States
Nuvance Health Medical Practices, Pulmonary & Sleep Specialists- Site Number : 119
Danbury, Connecticut, 06810-5038
United States
Meris Clinical Research-310 Oakfield Dr- Site Number : 115
Brandon, Florida, 33511-5706
United States
University of Florida - Gainesville - 1600 SW Archer Rd- Site Number : 101
Gainesville, Florida, 32610-3003
United States
Indiana University Health University Hospital- Site Number : 127
Indianapolis, Indiana, 46202
United States
Brigham and Women's Hospital -75 Francis Street- Site Number : 131
Boston, Massachusetts, 02115-6105
United States
University of Minnesota-420 Delaware Str SE- Site Number : 125
Minneapolis, Minnesota, 55455-0341
United States
Hannibal Regional Healthcare System-HRMG-Hannibal- Site Number : 111
Hannibal, Missouri, 63401-6890
United States
Columbia University Irving Medical Center- Site Number : 104
New York, New York, 10032-3729
United States
Oregon Health and Science University- Site Number : 117
Portland, Oregon, 97239
United States
Penn State Health Milton S. Hershey Medical Center- Site Number : 122
Hershey, Pennsylvania, 17033-2360
United States
Temple University Hospital - 3401 N Broad St- Site Number : 130
Philadelphia, Pennsylvania, 19140-5103
United States
Velocity Clinical Research - Spartanburg - PPDS- Site Number : 120
Spartanburg, South Carolina, 29303-4225
United States
Houston Methodist Hospital- Site Number : 113
Houston, Texas, 77030
United States
University of Utah Health Care- Site Number : 106
Salt Lake City, Utah, 84132-0001
United States

Collaborators and Investigators

Sponsor: Sanofi

  • Clinical Sciences & Operations, STUDY_DIRECTOR, Sanofi

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-06-20
Study Completion Date2028-09-30

Study Record Updates

Study Start Date2024-06-20
Study Completion Date2028-09-30

Terms related to this study

Keywords Provided by Researchers

  • AATD
  • Alpha 1-Antitrypsin Deficiency
  • Emphysema
  • INBRX-101
  • AAT
  • SAR447537

Additional Relevant MeSH Terms

  • Alpha 1-Antitrypsin Deficiency
  • Emphysema