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

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.

Phase 2 open label extension study to evaluate INBRX-101 in adults with AATD emphysema

Study Overview

• Status: Not yet recruiting
• Conditions: Emphysema; Alpha 1-Antitrypsin Deficiency
• Intervention / Treatment: Drug: INBRX-101

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.

• Study Type: Interventional
• Enrollment (Estimated): 130
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Christopher Burris; Phone Number: 858-500-7833; Email: clinicaltrials@inhibrx.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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% predicted at screening and post-bronchodilator FEV1/FVC<0.7 (Cohort 1 new patients only)
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 or suspected diagnosis of type 1 diabetes or diagnosed with uncontrolled type 2 diabetes
4. Received IV immunoglobulins, monoclonal antibodies and/or other biologic therapies within 30 days
5. On waiting list for lung or liver transplant
6. Acute respiratory tract infection or COPD exacerbation within 4 weeks prior to or during screening
7. Evidence of decompensated cirrhosis
8. Active cancers or has a history of malignancy within 5 years prior to screening
9. History of unstable cor pulmonale
10. Clinically significant congestive heart failure

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: INBRX-101 Q3W; IV every 3-weeks (Q3W)	Drug: INBRX-101; A1PI, Recombinant, Bivalent Fc Fusion Protein

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	3 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	3 years
Trough INBRX-101 concentration changes	Change in INBRX-101 concentration levels from baseline to end of treatment	3 years
Trough serum functional AAT (fAAT) concentration changes	Change in fAAT concentration levels from baseline to end of treatment	3 years
Covariate Analysis: Biometric Values: Weight	Assessment of the impact of patient's weight [in kg] on the pharmacokinetic profile of INBRX-101	3 years
Covariate Analysis: Biometric Values: Height	Assessment of the impact of patient's height [in cm] on the pharmacokinetic profile of INBRX-101	3 years
Covariate Analysis: Biometric Values: Age	Assessment of the impact of patient's age [in years] on the pharmacokinetic profile of INBRX-101	3 years
Covariate Analysis: Biometric Values: Sex	Assessment of the impact of patient's sex [male or female] on the pharmacokinetic profile of INBRX-101	3 years
Anti-drug antibodies	Frequency of anti-drug antibodies (ADA) against INBRX-101 as well as neutralizing ADA (NAb) against INBRX-101	3 years

Collaborators and Investigators

• Sponsor: Inhibrx, Inc.
• Investigators: Study Director: Erin Babcock, Inhibrx, Inc.

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2024
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): December 1, 2027

Study Registration Dates

• First Submitted: May 31, 2023
• First Submitted That Met QC Criteria: May 31, 2023
• First Posted (Actual): June 9, 2023

Study Record Updates

• Last Update Posted (Estimated): March 5, 2024
• Last Update Submitted That Met QC Criteria: March 4, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: Emphysema; AATD; Alpha 1-Antitrypsin Deficiency; AAT; INBRX-101
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Respiratory Tract Diseases; Lung Diseases; Disease Attributes; Liver Diseases; Genetic Diseases, Inborn; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive; Subcutaneous Emphysema; Chronic Disease; Pulmonary Emphysema; Emphysema; Alpha 1-Antitrypsin Deficiency
• Other Study ID Numbers: INBRX101-01-202

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No