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

  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% and ≤ 80% predicted at screening 5. Current non-smoking status.

Exclusion Criteria

  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 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

ArmDescriptionAssigned Intervention
Experimental
INBRX-101 Q3W 		IV every 3-weeks (Q3W) and placebo (normal saline)
  • Drug: INBRX-101
    A1PI, Recombinant, Bivalent Fc Fusion Protein
Experimental
INBRX-101 Q4W 		IV every 4-weeks (Q4W) and placebo (normal saline)
  • Drug: INBRX-101
    A1PI, Recombinant, Bivalent Fc Fusion Protein
Active Comparator
Zemaira (A1PI) 		60 mg/kg IV once weekly (QW) and placebo (normal saline)
  • Drug: Zemaira
    Alpha1-Proteinase Inhibitor (Human)

Recruiting Locations

University of Alabama at Birmingham
Birmingham, Alabama 35249
Contact:
Dianne Freemen
205-996-2709
dsmurphy@uabmc.edu

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.