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Study of SAR447537 (INBRX-101) Compared to Plasma-derived A1PI Therapy in Adults With AATD Emphysema

PHASE2ACTIVE_NOT_RECRUITING

Phase 2 study to compare SAR447537 (INBRX-101) to plasma derived A1PI therapy in adults with AATD emphysema.

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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.

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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% and ≤ 80% predicted at screening

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 SAR447537 (INBRX-101), A1PI or human IgG

Known selective or severe Immunoglobulin A (IgA) deficiency

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: 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

Image related to Alpha 1-Antitrypsin Deficiency

Condition: Alpha 1-Antitrypsin Deficiency, Emphysema
DRUG: INBRX-101 and other drugs
Brisbane, Queensland, Australia and more
Sponsor: Sanofi

You may be eligible to participate in this trial based on your search. Check eligibility by answering some questions.

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:

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 IV every 3-weeks (Q3W) and placebo (normal saline)	DRUG: INBRX-101 A1PI, Recombinant, Bivalent Fc Fusion Protein
EXPERIMENTAL: INBRX-101 Q4W IV every 4-weeks (Q4W) and placebo (normal saline)	DRUG: INBRX-101 A1PI, Recombinant, Bivalent Fc Fusion Protein
ACTIVE_COMPARATOR: Zemaira (A1PI) 60 mg/kg IV once weekly (QW) and placebo (normal saline)	DRUG: Zemaira Alpha1-Proteinase Inhibitor (Human)

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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References

Clinical Trials Gov: Study of SAR447537 (INBRX-101) Compared to Plasma-derived A1PI Therapy in Adults With AATD Emphysema