Long-term, Open-label Study of SAR447537 (INBRX-101) in Adults With Alpha-1 Antitrypsin Deficiency Emphysema
Purpose
Phase 2 open label extension study to evaluate SAR447537 (INBRX-101) in adults with AATD emphysema
Conditions
- Alpha 1-Antitrypsin Deficiency
- Emphysema
Eligibility
- Eligible Ages
- Between 18 Years and 80 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- 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 Criteria
- 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.
Study Design
- Phase
- Phase 2
- Study Type
- Interventional
- Allocation
- N/A
- Intervention Model
- Single Group Assignment
- Intervention Model Description
- Multicenter, single arm, open-label extension study
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental SAR447537 (INBRX-101) |
A1PI, Recombinant, Bivalent Fc Fusion Protein, in a solution for intravenous injection |
|
Recruiting Locations
University of Alabama at Birmingham- Site Number : 105
Birmingham, Alabama 35233
Birmingham, Alabama 35233
More Details
- Status
- Recruiting
- Sponsor
- Sanofi
Study Contact
Trial Transparency email recommended (Toll free for US & Canada)800-633-1610
Contact-us@sanofi.com
Detailed 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.