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

    Study type

    TREATMENT

    phase

    Phase

      PHASE2

    trial

    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

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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)
    DRUG: INBRX-101
    • A1PI, Recombinant, Bivalent Fc Fusion Protein

    What is the study measuring?

    Primary outcome

    Primary Outcome MeasurePrimary Outcome DescriptionPrimary Outcome Time Frame
    Long-term safety and tolerabilityIncidence 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 MeasureSecondary Outcome DescriptionSecondary 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 changesChange in INBRX-101 concentration levels from baseline to end of treatment3 years
    Trough serum functional AAT (fAAT) concentration changesChange in fAAT concentration levels from baseline to end of treatment3 years
    Covariate Analysis: Biometric Values: WeightAssessment of the impact of patient's weight \[in kg\] on the pharmacokinetic profile of INBRX-1013 years
    Covariate Analysis: Biometric Values: HeightAssessment of the impact of patient's height \[in cm\] on the pharmacokinetic profile of INBRX-1013 years
    Covariate Analysis: Biometric Values: AgeAssessment of the impact of patient's age \[in years\] on the pharmacokinetic profile of INBRX-1013 years
    Covariate Analysis: Biometric Values: SexAssessment of the impact of patient's sex \[male or female\] on the pharmacokinetic profile of INBRX-1013 years
    Anti-drug antibodiesFrequency of anti-drug antibodies (ADA) against INBRX-101 as well as neutralizing ADA (NAb) against INBRX-1013 years

    Frequently Asked Questions

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    References

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

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