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

Emphysema Clinical Trial

— 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.

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05897424
• Other study ID #: INBRX101-01-202
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: June 2024
• Est. completion date: December 2027

Study information

• Verified date: March 2024
• Source: Inhibrx, Inc.
• Contact: Christopher Burris
• Phone: 858-500-7833
• Email: clinicaltrials[@]inhibrx.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 130
• Est. completion date: December 2027
• Est. primary completion date: September 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Alpha 1-Antitrypsin Deficiency
• Emphysema
• Pulmonary Emphysema

Intervention

Drug:
• INBRX-101
A1PI, Recombinant, Bivalent Fc Fusion Protein

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Inhibrx, Inc.

Outcome

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