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

Sponsor
Inhibrx, Inc. (Industry)
Overall Status
Recruiting
CT.gov ID
NCT05856331
Collaborator
(none)
90
Enrollment
26
Locations
3
Arms
22
Anticipated Duration (Months)
3.5
Patients Per Site
0.2
Patients Per Site Per Month

Study Details

Study Description

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
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

Study Type:
Interventional
Anticipated Enrollment :
90 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Double-blind, randomized, active-control, parallel group interventional studyDouble-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
Anticipated Study Start Date :
May 1, 2023
Anticipated Primary Completion Date :
Jan 1, 2025
Anticipated Study Completion Date :
Mar 1, 2025

Arms and Interventions

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

Primary Outcome Measures

  1. Serum functional AAT (fAAT) levels at steady-state [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [32 Weeks]

    Assessment of the impact of patient's sex [male or female] on the pharmacokinetic profile of INBRX-101

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 80 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Locations

Site City State Country Postal Code
1 University of Alabama at Birmingham Birmingham Alabama United States 35249
2 David Geffen School of Medicine at UCLA Los Angeles California United States 90095
3 UC Davis Medical Center Sacramento California United States 95817
4 National Jewish Medical and Research Center Denver Colorado United States 80206
5 Western Connecticut Medical Group Danbury Connecticut United States 06810
6 GW Medical Faculty Associates - GW Cancer& Blood Disorders Washington District of Columbia United States 20037
7 GW Medical Faculty Associates Washington District of Columbia United States 20037
8 University of Florida Gainesville Florida United States 32610
9 University of Miami Miami Florida United States 33136
10 Pulmonary and Sleep of Tampa Bay Tampa Florida United States 33607
11 Cleveland Clinic Florida Weston Florida United States 33331
12 Loyola University Medical Center Maywood Illinois United States 60153
13 Hannibal Clinic Hannibal Missouri United States 63401
14 Pioneer Research Solutions Inc. Las Vegas Nevada United States 89106
15 Columbia University New York New York United States 10032
16 Oregon Health and Science University Portland Oregon United States 97006
17 Penn State Health Milton S. Hershey Medical Center Hershey Pennsylvania United States 17033
18 Velocity Clinical Research - Spartanburg - PPDS Spartanburg South Carolina United States 29303
19 Baylor Scott & White Research Institute Dallas Texas United States 75204
20 Houston Methodist Hospital Houston Texas United States 77030
21 University of Utah Health Salt Lake City Utah United States 84108
22 Donna McIntyre Brisbane Queensland Australia 2650
23 Queensland Centre for Pulmonary Transplantation Chermside Queensland Australia
24 Royal Adelaide Hospital North Adelaide South Australia Australia
25 St Vincent Hospital Melbourne Fitzroy Victoria Australia
26 Frankston Hospital Frankston Victoria Australia 3199

Sponsors and Collaborators

  • Inhibrx, Inc.

Investigators

  • Study Director: James Kalabus, Inhibrx, Inc.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Inhibrx, Inc.
ClinicalTrials.gov Identifier:
NCT05856331
Other Study ID Numbers:
  • INBRX101-01-201
First Posted:
May 12, 2023
Last Update Posted:
May 15, 2023
Last Verified:
May 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
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:
Alpha 1-Antitrypsin Deficiency
Pulmonary Emphysema
Emphysema
Alpha 1-Antitrypsin

Study Results

No Results Posted as of May 15, 2023