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 Sex
- 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
For newly identified participants 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. Uncontrolled diabetes mellitus despite adequate antidiabetic pharmacologic treatment with a screening HbA1c value ≥9% 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 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
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.