Phase 2 double blind study of INBRX-101 compared to A1PI therapy
Research type
Research Study
Full title
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
IRAS ID
1008715
Contact name
David Kao
Contact email
Sponsor organisation
Inhibrx, Inc.
Eudract number
2022-002234-14
Clinicaltrials.gov Identifier
Research summary
Study to assess the pharmacokinetic (PK, how the body affects the medication) and pharmacodynamics (PD, how the medication affects the body), immunogenicity (how the immune system reacts to the medication) and safety of the study medication, INBRX-101 and another treatment for alpha 1 antitrypsin deficiency (AATD) emphysema (lung disease, causing shortness of breath) called an alpha 1-proteinase inhibitor (A1PI) also known as Zemaira.
This study will be a randomised double blind study meaning that participants that enter this study will be randomly assigned to receive either INBHRX-101 or Zemaira and that neither the study doctor nor the participants will know if they are receiving INBRX-101 or Zemaira.
Participants with AATD emphysema have significantly lower blood level of the protein alpha 1 antitrypsin (AAT), AAT has an important function protecting the lungs. INBRX-101 is expected to raise the AAT level in the blood to ‘normal’ physiological levels. Current A1PI therapies fail to achieve normal levels. INBRX-101 differs from other AATD treatments as it has a special modification designed to prevent loss of the AAT activity over time, meaning the AAT is more stable and so remains in the lungs to function for longer, creating a clear unmet need for INBRX-101.
In this study participants will undergo screening (up to 7 weeks), washout if currently taking other A1PI medicines (5 weeks), before starting in the treatment period (32 treatment weeks ), to receive either INHRX-101 every 3 or 4 weeks, or A1PI therapy (Zemaira)weekly. Some participants will also be invited to participate in PK and/or bronchoscopy (tube into lungs from nose or mouth) sub-studies. The sub-studies will only take place at certain study sites. A 12= week follow up period will then commence.
Assessments will include assessment of vital signs as well as blood/urine tests, electrocardiogram, questionnaires, lung function tests, and a CT scan.
REC name
South Central - Hampshire A Research Ethics Committee
REC reference
23/SC/0400
Date of REC Opinion
3 Jan 2024
REC opinion
Further Information Favourable Opinion