Study of INBRX-101 Compared to Plasma-derived A1PI Therapy in Adults With AATD Emphysema
Purpose
Phase 2 study to compare INBRX-101 to plasma derived A1PI therapy 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% and ≤ 80% predicted at screening 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 INBRX-101, A1PI or human IgG 3. Known selective or severe Immunoglobulin A (IgA) deficiency 4. Known or suspected diagnosis of type 1 diabetes or diagnosed with uncontrolled type 2 diabetes 5. Received IV immunoglobulins, monoclonal antibodies and/or other biologic therapies within 30 days 6. On waiting list for lung or liver transplant 7. Acute respiratory tract infection or COPD exacerbation within 4 weeks prior to or during screening 8. Evidence of decompensated cirrhosis 9. Active cancers or has a history of malignancy within 5 years prior to screening 10. History of unstable cor pulmonale 11. Clinically significant congestive heart failure
Study Design
- Phase
- Phase 2
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Intervention Model Description
- Double-blind, randomized, active-control, parallel group interventional study
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental INBRX-101 Q3W |
IV every 3-weeks (Q3W) and placebo (normal saline) |
|
|
Experimental INBRX-101 Q4W |
IV every 4-weeks (Q4W) and placebo (normal saline) |
|
|
Active Comparator Zemaira (A1PI) |
60 mg/kg IV once weekly (QW) and placebo (normal saline) |
|
Recruiting Locations
University of Alabama at Birmingham
Birmingham, Alabama 35249
Birmingham, Alabama 35249
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, Double-Blind, Randomized, Active-Control, Parallel Group Study to Assess the Pharmacokinetics, Pharmacodynamics, Immunogenicity, and Safety of INBRX-101 Compared to Plasma-Derived Alpha1-Proteinase Inhibitor (A1PI) Augmentation Therapy in Adults With Alpha-1 Antitrypsin Deficiency (AATD) Emphysema.