Summary

Eligibility
for people ages 18-80 (full criteria)
Location
at UC Davis UCLA
Dates
study started
completion around
Principal Investigator
by Barjaktarevic (ucla)Brooks Kuhn (ucdavis)

Description

Summary

Phase 2 study to compare INBRX-101 to plasma derived A1PI therapy in adults with AATD emphysema

Official Title

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

Details

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.

Keywords

Alpha 1-Antitrypsin Deficiency, Emphysema, AATD, INBRX-101, A1PI, AAT, Pulmonary Emphysema, Alpha 1-Antitrypsin, Zemaira, INBRX-101 Q3W, INBRX-101 Q4W, Zemaira (A1PI)

Eligibility

You can join if…

Open to people ages 18-80

  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.

You CAN'T join if...

  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

Locations

  • David Geffen School of Medicine accepting new patients
    Los Angeles California 90095 United States
  • UC Davis Medical Center accepting new patients
    Sacramento California 95817 United States

Lead Scientists at University of California Health

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Sanofi
ID
NCT05856331
Phase
Phase 2 research study
Study Type
Interventional
Participants
Expecting 90 study participants
Last Updated