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

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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

    Study type

    TREATMENT

    phase

    Phase

      PHASE2

    trial

    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

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    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/ArmIntervention/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 MeasurePrimary Outcome DescriptionPrimary Outcome Time Frame
    Serum functional AAT (fAAT) levels at steady-stateTo 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 A1PI32 Weeks

    Secondary outcome

    Secondary Outcome MeasureSecondary Outcome DescriptionSecondary Outcome Time Frame
    fAAT Concentration changesMean 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 rangePercentage 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 TEAEsIncidence 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 antibodiesFrequency 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: ClearanceModeling by means of appropriate software to characterize the pharmacokinetic profile of INBRX-101 via estimation of the parameter clearance32 Weeks
    Population Pharmacokinetics: Volume of DistributionModeling by means of appropriate software to characterize the pharmacokinetic profile of INBRX-101 via estimation of the parameter volume of distribution32 Weeks
    Covariate Analysis: Biometric Values: WeightAssessment of the impact of patient's weight \[in kg\] on the pharmacokinetic profile of INBRX-10132 Weeks
    Covariate Analysis: Biometric Values: HeightAssessment of the impact of patient's height \[in cm\] on the pharmacokinetic profile of INBRX-10132 Weeks
    Covariate Analysis: Biometric Values: AgeAssessment of the impact of patient's age \[in years\] on the pharmacokinetic profile of INBRX-10132 Weeks
    Covariate Analysis: Biometric Values: SexAssessment of the impact of patient's sex \[male or female\] on the pharmacokinetic profile of INBRX-10132 Weeks

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    References

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

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