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

  • Barjaktarevic (ucla)
  • Brooks Kuhn (ucdavis)
    Assistant Professor, Pulmonary, Critical Care, and Sleep Medicine, School of Medicine. Authored (or co-authored) 24 research publications

Details

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