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

Sponsor

Inhibrx, Inc. (Industry)

Overall Status

Not yet recruiting

CT.gov ID

NCT05897424

Collaborator

(none)

130

Enrollment

Arm

Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Alpha 1-Antitrypsin Deficiency Emphysema	Drug: INBRX-101	Phase 2

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 Design

Study Type:

Interventional

Anticipated Enrollment :

130 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Intervention Model Description:

Multicenter, single arm, open-label extension studyMulticenter, single arm, open-label extension study

Masking:

None (Open Label)

Primary Purpose:

Treatment

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.

Anticipated Study Start Date :

Jan 1, 2024

Anticipated Primary Completion Date :

Sep 1, 2027

Anticipated Study Completion Date :

Dec 1, 2027

Arms and Interventions

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

Arm

Intervention/Treatment

Experimental: INBRX-101 Q3W

IV every 3-weeks (Q3W)

Drug: INBRX-101

A1PI, Recombinant, Bivalent Fc Fusion Protein

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts 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