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INBRX101-201

  • Status
    Accepting Candidates
  • Age
    18 Years - 80 Years
  • Sexes
    All
  • Healthy Volunteers
    No
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Objective

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

Description

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.

Details

Full study title A Phase 2, Double-Blind, Randomized, Active-Control, Parallel Group Study To Assess The Pharmacokinetics, Pharmacodynamics, Immunogenicity, And Safety Of INBRX-101 Compared To Plasma Derived Alpha1-Proteinase Inhibitor (A1PI) Augmentation Therapy In Adults With Alpha-1 Antitrypsin Deficiency (AATD) Emphysema
Protocol number OCR44156
ClinicalTrials.gov ID NCT05856331
Phase Phase 2

Eligibility

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 鈮� 30% and 鈮� 80% predicted at screening

  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 (INBRX-101. , A1PI or human IgG

  3. Known selective or severe Immunoglobulin A (IgA) deficiency

  4. Known or suspected diagnosis of type 1 diabetes or diagnosed with uncontrolled type 2 diabetes

  5. Received IV immunoglobulins, monoclonal antibodies and/or other biologic therapies within 30 days

  6. On waiting list for lung or liver transplant

  7. Acute respiratory tract infection or COPD exacerbation within 4 weeks prior to or during screening

  8. Evidence of decompensated cirrhosis

  9. Active cancers or has a history of malignancy within 5 years prior to screening

  10. History of unstable cor pulmonale

  11. Clinically significant congestive heart failure

Lead researcher

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  2. Step
    2

    Get screened to confirm eligibility

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