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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT05856331
Registration number
NCT05856331
Ethics application status
Date submitted
28/03/2023
Date registered
12/05/2023
Date last updated
4/06/2024
Titles & IDs
Public title
Study of INBRX-101 Compared to Plasma-derived A1PI Therapy in Adults With AATD Emphysema
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Scientific 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
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Secondary ID [1]
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INBRX101-01-201
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Universal Trial Number (UTN)
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Trial acronym
ELEVAATE
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Alpha 1-Antitrypsin Deficiency
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Emphysema
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Condition category
Condition code
Human Genetics and Inherited Disorders
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Other human genetics and inherited disorders
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Respiratory
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Other respiratory disorders / diseases
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - INBRX-101
Treatment: Drugs - Zemaira
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)
Treatment: Drugs: INBRX-101
A1PI, Recombinant, Bivalent Fc Fusion Protein
Treatment: Drugs: Zemaira
Alpha1-Proteinase Inhibitor (Human)
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Serum functional AAT (fAAT) levels at steady-state
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Assessment method [1]
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To assess the mean change in average fAAT concentration as measured by anti-neutrophil elastase capacity [ANEC] from baseline to average serum trough fAAT concentration at steady-state (Ctrough,ss) in patients treated with INBRX-101 compared to A1PI
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Timepoint [1]
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32 Weeks
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Secondary outcome [1]
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fAAT Concentration changes
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Assessment method [1]
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Mean change in fAAT concentration from baseline to fAAT average concentration at steady-state (Cavg, ss) in patients treated with INBRX-101 compared to A1PI.
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Timepoint [1]
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32 Weeks
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Secondary outcome [2]
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Days with fAAT above the lower limit of the normal range
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Assessment method [2]
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Percentage of days with fAAT above the lower limit of the normal range during steady-state dosing in patients treated with INBRX-101 compared to A1PI.
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Timepoint [2]
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32 weeks
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Secondary outcome [3]
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Incidence of TEAEs
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Assessment method [3]
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Incidence of all treatment-emergent adverse events (TEAEs), TEAEs = Grade 3, serious adverse events (SAEs), TEAEs requiring withdrawal from IP treatment, and infusion reactions will be determined.
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Timepoint [3]
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32 Weeks
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Secondary outcome [4]
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Anti-drug antibodies
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Assessment method [4]
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Frequency of anti-drug antibodies (ADA) against INBRX-101 and endogenous AAT, as well as neutralizing ADA (NAb) against INBRX-101 and endogenous AAT will be determined.
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Timepoint [4]
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32 Weeks
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Secondary outcome [5]
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Population Pharmacokinetics: Clearance
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Assessment method [5]
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Modeling by means of appropriate software to characterize the pharmacokinetic profile of INBRX-101 via estimation of the parameter clearance
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Timepoint [5]
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32 Weeks
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Secondary outcome [6]
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Population Pharmacokinetics: Volume of Distribution
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Assessment method [6]
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Modeling by means of appropriate software to characterize the pharmacokinetic profile of INBRX-101 via estimation of the parameter volume of distribution
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Timepoint [6]
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32 Weeks
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Secondary outcome [7]
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Covariate Analysis: Biometric Values: Weight
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Assessment method [7]
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Assessment of the impact of patient's weight [in kg] on the pharmacokinetic profile of INBRX-101
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Timepoint [7]
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32 Weeks
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Secondary outcome [8]
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Covariate Analysis: Biometric Values: Height
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Assessment method [8]
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Assessment of the impact of patient's height [in cm] on the pharmacokinetic profile of INBRX-101
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Timepoint [8]
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32 Weeks
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Secondary outcome [9]
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Covariate Analysis: Biometric Values: Age
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Assessment method [9]
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Assessment of the impact of patient's age [in years] on the pharmacokinetic profile of INBRX-101
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Timepoint [9]
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32 Weeks
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Secondary outcome [10]
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Covariate Analysis: Biometric Values: Sex
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Assessment method [10]
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Assessment of the impact of patient's sex [male or female] on the pharmacokinetic profile of INBRX-101
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Timepoint [10]
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32 Weeks
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Eligibility
Key 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.
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Minimum age
18
Years
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Maximum age
80
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key 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
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 2
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
12/10/2023
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
1/06/2025
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Actual
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Sample size
Target
90
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
QLD,SA,VIC,WA
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Recruitment hospital [1]
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Donna McIntyre - Brisbane
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Recruitment hospital [2]
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Queensland Centre for Pulmonary Transplantation - Chermside
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Recruitment hospital [3]
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Royal Adelaide Hospital - North Adelaide
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Recruitment hospital [4]
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Eastern Health Clinical School - Box Hill
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Recruitment hospital [5]
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St Vincent Hospital Melbourne - Fitzroy
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Recruitment hospital [6]
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Frankston Hospital - Frankston
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Recruitment hospital [7]
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Institute for Respiratory Health - Nedlands
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Recruitment postcode(s) [1]
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2650 - Brisbane
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Recruitment postcode(s) [2]
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- Chermside
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Recruitment postcode(s) [3]
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5065 - North Adelaide
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Recruitment postcode(s) [4]
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3128 - Box Hill
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Recruitment postcode(s) [5]
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- Fitzroy
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Recruitment postcode(s) [6]
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3199 - Frankston
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Recruitment postcode(s) [7]
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6009 - Nedlands
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Recruitment outside Australia
Country [1]
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United States of America
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State/province [1]
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Alabama
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Arizona
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California
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Colorado
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Connecticut
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Florida
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Illinois
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Indiana
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Massachusetts
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Minnesota
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Missouri
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Oregon
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Pennsylvania
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South Carolina
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Texas
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Utah
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New Zealand
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Auckland
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New Zealand
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Wellington
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United Kingdom
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Angus
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United Kingdom
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Cheshire
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United Kingdom
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Devon
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United Kingdom
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Hampshire
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Country [24]
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United Kingdom
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State/province [24]
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Warwickshire
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Inhibrx Biosciences, Inc
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
Phase 2 study to compare INBRX-101 to plasma derived A1PI therapy in adults with AATD
emphysema
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Trial website
https://clinicaltrials.gov/ct2/show/NCT05856331
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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James Kalabus
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Address
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Inhibrx Biosciences, Inc
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Gabe Berman
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Address
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Country
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Phone
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858-500-7833
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT05856331
Download to PDF