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Study of INBRX-101 Compared to Plasma-derived A1PI Therapy in Adults With AATD Emphysema (ELEVAATE)

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ClinicalTrials.gov Identifier: NCT05856331
Recruitment Status : Recruiting
First Posted : May 12, 2023
Last Update Posted : April 24, 2024
Sponsor:
Information provided by (Responsible Party):
Inhibrx, Inc.

Study Description
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Brief Summary:
Phase 2 study to compare INBRX-101 to plasma derived A1PI therapy in adults with AATD emphysema

Condition or disease Intervention/treatment Phase
Alpha 1-Antitrypsin Deficiency Emphysema Drug: INBRX-101 Drug: Zemaira Phase 2

Detailed Description:
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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Double-blind, randomized, active-control, parallel group interventional study
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Actual Study Start Date : October 12, 2023
Estimated Primary Completion Date : November 2024
Estimated Study Completion Date : March 2025

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: INBRX-101 Q3W
IV every 3-weeks (Q3W) and placebo (normal saline)
 Drug: INBRX-101
A1PI, Recombinant, Bivalent Fc Fusion Protein
Experimental: INBRX-101 Q4W
IV every 4-weeks (Q4W) and placebo (normal saline)
 Drug: INBRX-101
A1PI, Recombinant, Bivalent Fc Fusion Protein
Active Comparator: Zemaira (A1PI)
60 mg/kg IV once weekly (QW) and placebo (normal saline)
 Drug: Zemaira
Alpha1-Proteinase Inhibitor (Human)


Outcome Measures
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Primary Outcome Measures :
  1. Serum functional AAT (fAAT) levels at steady-state [ Time Frame: 32 Weeks ]
    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


Secondary Outcome Measures :
  1. fAAT Concentration changes [ Time Frame: 32 Weeks ]
    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.

  2. Days with fAAT above the lower limit of the normal range [ Time Frame: 32 weeks ]
    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.

  3. Incidence of TEAEs [ Time Frame: 32 Weeks ]
    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.

  4. Anti-drug antibodies [ Time Frame: 32 Weeks ]
    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.

  5. Population Pharmacokinetics: Clearance [ Time Frame: 32 Weeks ]
    Modeling by means of appropriate software to characterize the pharmacokinetic profile of INBRX-101 via estimation of the parameter clearance

  6. Population Pharmacokinetics: Volume of Distribution [ Time Frame: 32 Weeks ]
    Modeling by means of appropriate software to characterize the pharmacokinetic profile of INBRX-101 via estimation of the parameter volume of distribution

  7. Covariate Analysis: Biometric Values: Weight [ Time Frame: 32 Weeks ]
    Assessment of the impact of patient's weight [in kg] on the pharmacokinetic profile of INBRX-101

  8. Covariate Analysis: Biometric Values: Height [ Time Frame: 32 Weeks ]
    Assessment of the impact of patient's height [in cm] on the pharmacokinetic profile of INBRX-101

  9. Covariate Analysis: Biometric Values: Age [ Time Frame: 32 Weeks ]
    Assessment of the impact of patient's age [in years] on the pharmacokinetic profile of INBRX-101

  10. Covariate Analysis: Biometric Values: Sex [ Time Frame: 32 Weeks ]
    Assessment of the impact of patient's sex [male or female] on the pharmacokinetic profile of INBRX-101


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05856331


Contacts
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Contact: Gabe Berman 858-500-7833 clinicaltrials@inhibrx.com

Locations
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Sponsors and Collaborators
Inhibrx, Inc.
Investigators
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Study Director: James Kalabus Inhibrx, Inc.
More Information
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Responsible Party: Inhibrx, Inc.
ClinicalTrials.gov Identifier: NCT05856331    
Other Study ID Numbers: INBRX101-01-201
First Posted: May 12, 2023    Key Record Dates
Last Update Posted: April 24, 2024
Last Verified: April 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Inhibrx, Inc.:
AATD
Alpha 1-Antitrypsin Deficiency
Emphysema
 INBRX-101
A1PI
AAT
Additional relevant MeSH terms:
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Alpha 1-Antitrypsin Deficiency
Pulmonary Emphysema
Emphysema
Pathologic Processes
Pulmonary Disease, Chronic Obstructive
Lung Diseases, Obstructive
Lung Diseases
Respiratory Tract Diseases
Chronic Disease
Disease Attributes
 Liver Diseases
Digestive System Diseases
Genetic Diseases, Inborn
Subcutaneous Emphysema
Alpha 1-Antitrypsin
Trypsin Inhibitors
Serine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action