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Open Label Extension Study of INBRX-101 in Adults With AATD Emphysema (ELEVAATE OLE)

Primary Purpose

Alpha 1-Antitrypsin Deficiency, Emphysema

Status
Not yet recruiting
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
INBRX-101
Sponsored by
Inhibrx, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alpha 1-Antitrypsin Deficiency focused on measuring AATD, Alpha 1-Antitrypsin Deficiency, Emphysema, INBRX-101, AAT

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Males or females 18-80 years of age, inclusive, at the time of screening Diagnosis of AATD Evidence of emphysema secondary to AATD FEV1 of ≥ 30% predicted at screening and post-bronchodilator FEV1/FVC<0.7 (Cohort 1 new patients only) Current non-smoking status Exclusion Criteria: Receipt of A1PI augmentation therapy within 5 weeks prior to the first dose of study drug Known or suspected allergy to components of INBRX-101, A1PI or human IgG Known or suspected diagnosis of type 1 diabetes or diagnosed with uncontrolled type 2 diabetes Received IV immunoglobulins, monoclonal antibodies and/or other biologic therapies within 30 days On waiting list for lung or liver transplant Acute respiratory tract infection or COPD exacerbation within 4 weeks prior to or during screening Evidence of decompensated cirrhosis Active cancers or has a history of malignancy within 5 years prior to screening History of unstable cor pulmonale Clinically significant congestive heart failure

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    INBRX-101 Q3W

    Arm Description

    IV every 3-weeks (Q3W)

    Outcomes

    Primary Outcome Measures

    Long-term safety and tolerability
    Incidence of all treatment emergent adverse events (TEAEs), TEAEs ≥ Grade 3, serious adverse events (SAEs), TEAEs requiring withdrawal from investigational product (IP) treatment, and adverse events of special interest (AESIs).

    Secondary Outcome Measures

    Change in lung density by quantitative computerized tomography (CT)
    Assess the annual rate of change in lung density assessed by serial quantitative CT (15th percentile point, PD15) at total lung capacity (TLC), centrally read, from baseline to end of treatment.
    Trough INBRX-101 concentration changes
    Change in INBRX-101 concentration levels from baseline to end of treatment
    Trough serum functional AAT (fAAT) concentration changes
    Change in fAAT concentration levels from baseline to end of treatment
    Covariate Analysis: Biometric Values: Weight
    Assessment of the impact of patient's weight [in kg] on the pharmacokinetic profile of INBRX-101
    Covariate Analysis: Biometric Values: Height
    Assessment of the impact of patient's height [in cm] on the pharmacokinetic profile of INBRX-101
    Covariate Analysis: Biometric Values: Age
    Assessment of the impact of patient's age [in years] on the pharmacokinetic profile of INBRX-101
    Covariate Analysis: Biometric Values: Sex
    Assessment of the impact of patient's sex [male or female] on the pharmacokinetic profile of INBRX-101
    Anti-drug antibodies
    Frequency of anti-drug antibodies (ADA) against INBRX-101 as well as neutralizing ADA (NAb) against INBRX-101

    Full Information

    First Posted
    May 31, 2023
    Last Updated
    May 31, 2023
    Sponsor
    Inhibrx, Inc.
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05897424
    Brief Title
    Open Label Extension Study of INBRX-101 in Adults With AATD Emphysema
    Acronym
    ELEVAATE OLE
    Official Title
    This is a Phase 2, Single Arm, Open Label Extension Study, Evaluating the Long-Term Safety and Clinical Efficacy of INBRX-101 in Adults With Alpha-1 Antitrypsin Deficiency (AATD) Emphysema.
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    January 2024 (Anticipated)
    Primary Completion Date
    September 2027 (Anticipated)
    Study Completion Date
    December 2027 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Inhibrx, Inc.

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    Yes
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    Phase 2 open label extension study to evaluate INBRX-101 in adults with AATD emphysema
    Detailed Description
    This is a Phase 2, Single Arm, Open Label Extension Study, Evaluating the Long-Term Safety and Clinical Efficacy of INBRX-101 in Adults With Alpha-1 Antitrypsin Deficiency (AATD) Emphysema.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Alpha 1-Antitrypsin Deficiency, Emphysema
    Keywords
    AATD, Alpha 1-Antitrypsin Deficiency, Emphysema, INBRX-101, AAT

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Single Group Assignment
    Model Description
    Multicenter, single arm, open-label extension study
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    130 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    INBRX-101 Q3W
    Arm Type
    Experimental
    Arm Description
    IV every 3-weeks (Q3W)
    Intervention Type
    Drug
    Intervention Name(s)
    INBRX-101
    Intervention Description
    A1PI, Recombinant, Bivalent Fc Fusion Protein
    Primary Outcome Measure Information:
    Title
    Long-term safety and tolerability
    Description
    Incidence of all treatment emergent adverse events (TEAEs), TEAEs ≥ Grade 3, serious adverse events (SAEs), TEAEs requiring withdrawal from investigational product (IP) treatment, and adverse events of special interest (AESIs).
    Time Frame
    3 years
    Secondary Outcome Measure Information:
    Title
    Change in lung density by quantitative computerized tomography (CT)
    Description
    Assess the annual rate of change in lung density assessed by serial quantitative CT (15th percentile point, PD15) at total lung capacity (TLC), centrally read, from baseline to end of treatment.
    Time Frame
    3 years
    Title
    Trough INBRX-101 concentration changes
    Description
    Change in INBRX-101 concentration levels from baseline to end of treatment
    Time Frame
    3 years
    Title
    Trough serum functional AAT (fAAT) concentration changes
    Description
    Change in fAAT concentration levels from baseline to end of treatment
    Time Frame
    3 years
    Title
    Covariate Analysis: Biometric Values: Weight
    Description
    Assessment of the impact of patient's weight [in kg] on the pharmacokinetic profile of INBRX-101
    Time Frame
    3 years
    Title
    Covariate Analysis: Biometric Values: Height
    Description
    Assessment of the impact of patient's height [in cm] on the pharmacokinetic profile of INBRX-101
    Time Frame
    3 years
    Title
    Covariate Analysis: Biometric Values: Age
    Description
    Assessment of the impact of patient's age [in years] on the pharmacokinetic profile of INBRX-101
    Time Frame
    3 years
    Title
    Covariate Analysis: Biometric Values: Sex
    Description
    Assessment of the impact of patient's sex [male or female] on the pharmacokinetic profile of INBRX-101
    Time Frame
    3 years
    Title
    Anti-drug antibodies
    Description
    Frequency of anti-drug antibodies (ADA) against INBRX-101 as well as neutralizing ADA (NAb) against INBRX-101
    Time Frame
    3 years

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    80 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Males or females 18-80 years of age, inclusive, at the time of screening Diagnosis of AATD Evidence of emphysema secondary to AATD FEV1 of ≥ 30% predicted at screening and post-bronchodilator FEV1/FVC<0.7 (Cohort 1 new patients only) Current non-smoking status Exclusion Criteria: Receipt of A1PI augmentation therapy within 5 weeks prior to the first dose of study drug Known or suspected allergy to components of INBRX-101, A1PI or human IgG Known or suspected diagnosis of type 1 diabetes or diagnosed with uncontrolled type 2 diabetes Received IV immunoglobulins, monoclonal antibodies and/or other biologic therapies within 30 days On waiting list for lung or liver transplant Acute respiratory tract infection or COPD exacerbation within 4 weeks prior to or during screening Evidence of decompensated cirrhosis Active cancers or has a history of malignancy within 5 years prior to screening History of unstable cor pulmonale Clinically significant congestive heart failure
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Christopher Burris
    Phone
    858-500-7833
    Email
    clinicaltrials@inhibrx.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Erin Babcock
    Organizational Affiliation
    Inhibrx, Inc.
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Learn more about this trial

    Open Label Extension Study of INBRX-101 in Adults With AATD Emphysema

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