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

PHASE2RECRUITING

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

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Study details:

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.

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Eligibility criteria

Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.

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

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Eligibility

Age eligible for study : 18 and older

Healthy volunteers accepted : No

Gender eligible for study: All

Things to know

Study dates

Study start: 2024-06-20

Primary completion: 2028-06-01

Study completion finish: 2028-09-01

Study type

TREATMENT

Phase

PHASE2

Trial ID

NCT05897424

Intervention or treatment

DRUG: INBRX-101

Conditions

• Alpha 1-Antitrypsin Deficiency
• Emphysema

Image related to Alpha 1-Antitrypsin Deficiency

Condition: Alpha 1-Antitrypsin Deficiency, Emphysema
DRUG: INBRX-101
Chermside, Queensland, Australia
Sponsor: Sanofi

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Are you running this trial? If you're a clinic or sponsor, you can claim this study. Claim or learn more.

Find a site

Closest Location:

Lung Research Qld

Research sites nearby

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Lung Research Qld
Chermside, Queensland, Australia

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

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

Primary Outcome Measure	Primary Outcome Description	Primary Outcome 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

Secondary Outcome Measure	Secondary Outcome Description	Secondary Outcome 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

Frequently Asked Questions

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You may be eligible to participate in this trial based on your search.Apply for study

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References

Clinical Trials Gov: Open Label Extension Study of INBRX-101 in Adults With AATD Emphysema