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Study of SAR447537 (INBRX-101) Compared to Plasma-derived A1PI Therapy in Adults With AATD Emphysema
Phase 2 study to compare SAR447537 (INBRX-101) to plasma derived A1PI therapy in adults with AATD emphysema.
Study details:
This is a Phase 2, Double-Blind, Randomized, Active-Control, Parallel Group Study to Assess the Pharmacokinetics, Pharmacodynamics, Immunogenicity, and Safety of SAR447537 (INBRX-101) Compared to Plasma-Derived Alpha1-Proteinase Inhibitor (A1PI) Augmentation Therapy 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: 2023-10-12
Primary completion: 2025-08-07
Study completion finish: 2025-10-30
Study type
TREATMENT
Phase
PHASE2
Trial ID
NCT05856331
Intervention or treatment
DRUG: INBRX-101
DRUG: Zemaira
Conditions
- • Alpha 1-Antitrypsin Deficiency
- • Emphysema
Find a site
Closest Location:
Donna McIntyre
Research sites nearby
Select from list below to view details:
Donna McIntyre
Brisbane, Queensland, Australia
Queensland Centre for Pulmonary Transplantation
Chermside, Queensland, Australia
Royal Adelaide Hospital
North Adelaide, South Australia, Australia
Eastern Health Clinical School
Box Hill, Victoria, 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
|
EXPERIMENTAL: INBRX-101 Q4W
| DRUG: INBRX-101
|
ACTIVE_COMPARATOR: Zemaira (A1PI)
| DRUG: Zemaira
|
What is the study measuring?
Primary outcome
Primary Outcome Measure | Primary Outcome Description | Primary Outcome Time Frame |
---|---|---|
Serum functional AAT (fAAT) levels at steady-state | To assess the mean change in average fAAT concentration as measured by anti-neutrophil elastase capacity \[ANEC\] from baseline to average serum trough fAAT concentration at steady-state (Ctrough,ss) in patients treated with INBRX-101 compared to A1PI | 32 Weeks |
Secondary outcome
Secondary Outcome Measure | Secondary Outcome Description | Secondary Outcome Time Frame |
---|---|---|
fAAT Concentration changes | Mean change in fAAT concentration from baseline to fAAT average concentration at steady-state (Cavg, ss) in patients treated with INBRX-101 compared to A1PI. | 32 Weeks |
Days with fAAT above the lower limit of the normal range | Percentage of days with fAAT above the lower limit of the normal range during steady-state dosing in patients treated with INBRX-101 compared to A1PI. | 32 weeks |
Incidence of TEAEs | Incidence of all treatment-emergent adverse events (TEAEs), TEAEs ≥ Grade 3, serious adverse events (SAEs), TEAEs requiring withdrawal from IP treatment, and infusion reactions will be determined. | 32 Weeks |
Anti-drug antibodies | Frequency of anti-drug antibodies (ADA) against INBRX-101 and endogenous AAT, as well as neutralizing ADA (NAb) against INBRX-101 and endogenous AAT will be determined. | 32 Weeks |
Population Pharmacokinetics: Clearance | Modeling by means of appropriate software to characterize the pharmacokinetic profile of INBRX-101 via estimation of the parameter clearance | 32 Weeks |
Population Pharmacokinetics: Volume of Distribution | Modeling by means of appropriate software to characterize the pharmacokinetic profile of INBRX-101 via estimation of the parameter volume of distribution | 32 Weeks |
Covariate Analysis: Biometric Values: Weight | Assessment of the impact of patient's weight \[in kg\] on the pharmacokinetic profile of INBRX-101 | 32 Weeks |
Covariate Analysis: Biometric Values: Height | Assessment of the impact of patient's height \[in cm\] on the pharmacokinetic profile of INBRX-101 | 32 Weeks |
Covariate Analysis: Biometric Values: Age | Assessment of the impact of patient's age \[in years\] on the pharmacokinetic profile of INBRX-101 | 32 Weeks |
Covariate Analysis: Biometric Values: Sex | Assessment of the impact of patient's sex \[male or female\] on the pharmacokinetic profile of INBRX-101 | 32 Weeks |
Frequently Asked Questions
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