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Open Label Extension Study of INBRX-101 in Adults With AATD Emphysema
Phase 2 open label extension study to evaluate INBRX-101 in adults with AATD emphysema.
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.
Eligibility criteria
Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.
Inclusion criteria
Exclusion criteria
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
Find a site
Closest Location:
Lung Research Qld
Research sites nearby
Select from list below to view details:
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
| DRUG: INBRX-101
|
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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