OverviewStudy detailsEligibilityThings to knowResearchStudy plan
info
Simplify with AI

Long-term, Open-label Study of SAR447537 (INBRX-101) in Adults With Alpha-1 Antitrypsin Deficiency Emphysema

PHASE2ACTIVE_NOT_RECRUITING

Phase 2 open label extension study to evaluate SAR447537 (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 SAR447537 (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

  1. Males or females 18-80 years of age, inclusive, at the time of screening
  2. Diagnosis of AATD
  3. Evidence of emphysema secondary to AATD
  4. FEV1 of ≥ 30% predicted at screening and post-bronchodilator FEV1/FVC<0.7
  5. Current non-smoking status

Exclusion criteria

  1. Receipt of A1PI augmentation therapy within 5 weeks prior to the first dose of study drug
  2. Known or suspected allergy to components of SAR447537, A1PI or human IgG
  3. Uncontrolled diabetes mellitus despite adequate antidiabetic pharmacologic treatment with a screening HbA1c value ≥9%
  4. Received IV immunoglobulins, monoclonal antibodies and/or other biologic therapies within 30 days
  5. On waiting list for lung or liver transplant
  6. Acute respiratory tract infection or COPD exacerbation within 4 weeks prior to or during screening
  7. Evidence of decompensated cirrhosis
  8. Active cancers or has a history of malignancy within 5 years prior to screening
  9. History of unstable cor pulmonale

Eligibility

Age eligible for study : NA

Healthy volunteers accepted : No

Gender eligible for study: ALL

Things to know

Study dates

Study start:

Primary completion:

Study completion finish:

study type

Study type

TREATMENT

phase

Phase

    PHASE2

trial

Study ID

NCT05897424

Intervention or treatment

DRUG: SAR447537

Conditions

  • Alpha 1-Antitrypsin Deficiency
  • Emphysema

  • Condition: Alpha 1-Antitrypsin Deficiency, Emphysema

  • DRUG: SAR447537

  • Brisbane, Queensland, Australia and more

  • Sponsor: Sanofi

Save

Share

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

Research sites nearby

Closest Location:

Investigational Site Number : 202

Select from list below to view details:

  • Investigational Site Number : 202

    Brisbane, Queensland, Australia

  • Investigational Site Number : 204

    South Brisbane, Queensland, Australia

  • Investigational Site Number : 201

    Adelaide, South Australia, Australia

  • Investigational Site Number : 205

    Frankston, Victoria, Australia

Loading map...

Who is running the clinical trial?

S

Sanofi

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: SAR447537 (INBRX-101)
  • A1PI, Recombinant, Bivalent Fc Fusion Protein, in a solution for intravenous injection
Drug: SAR447537

    What is the study measuring?

    Primary Outcome

    MeasureDescriptionTime Frame
    Long-term safety and tolerabilityIncidence of all treatment emergent adverse events (TEAEs), TEAEs ≥ Grade 3, serious adverse events (SAEs), TEAEs leading to discontinuation from SAR447537, and adverse events of special interest (AESIs) (including infusion-related reactions).3 years

    Secondary Outcome

    MeasureDescriptionTime 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 (EoT).3 years
    Trough SAR447537 concentration changesChange in SAR447537 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 participant's weight \[in kg\] on the pharmacokinetic profile of SAR4475373 years
    Covariate Analysis: Biometric Values: HeightAssessment of the impact of participant's height \[in cm\] on the pharmacokinetic profile of SAR4475373 years
    Covariate Analysis: Biometric Values: AgeAssessment of the impact of participant's age \[in years\] on the pharmacokinetic profile of SAR4475373 years
    Covariate Analysis: Biometric Values: SexAssessment of the impact of participant's sex \[male or female\] on the pharmacokinetic profile of SAR4475373 years
    Anti-drug antibodiesFrequency of anti-drug antibodies (ADA) against SAR447537 as well as neutralizing ADA (NAb) against SAR4475373 years
    Are you running this trial?If you're a clinic or sponsor, you can claim this study.
    Claim this trial

    References

    Clinical Trials Gov: Long-term, Open-label Study of SAR447537 (INBRX-101) in Adults With Alpha-1 Antitrypsin Deficiency Emphysema

    Other trials to consider

    Loading suggested trials...

    Top searched conditions

    Breast CancerLung CancerType 2 DiabetesDermatitisAlzheimersParkinsonsLupusCrohn’s DiseaseAsthmaHypertensionCOPDMultiple SclerosisOsteoarthritisHIV/AIDSPsoriasisStrokeObesityProstate CancerDepressionCardiovascular