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(352) 733-0111

ELEVAATE OLE

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

Phase 2 open label extension study to evaluate INBRX-101 in adults with AATD emphysema

Description

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.

Details

Full study title A Phase 2, Single Arm, Open Label Extension Study Evaluating the Long Term Safety and Clinical Efficacy of INBRX101 in Adults with Alpha1 Antitrypsin Deficiency (AATD) Emphysema
Protocol number OCR45850
ClinicalTrials.gov ID NCT05897424
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 ≥ 30% predicted at screening and post-bronchodilator FEV1/FVC

Lead researcher

Participate in a study

Here are some general steps to consider when participating in a research study:

  1. Step
    1

    Contact the research team

    Call or email the research team listed within the specific clinical trial or study to let them know that you're interested. A member of the research team, such as the researcher or study coordinator, will be available to tell you more about the study and to answer any questions or concerns you may have.

    Primary contact

  2. Step
    2

    Get screened to confirm eligibility

    You may be asked to take part in prescreening to make sure you are eligible for a study. The prescreening process ensures it is safe for you to participate. During the prescreening process, you will be asked some questions and you may also be asked to schedule tests or procedures to confirm your eligibility.

  3. Step
    3

    Provide your consent to participate

    If you are eligible and want to join the clinical trial or study, a member of the research team will ask for your consent to participate. To give consent, you will be asked to read and sign a consent form for the study. This consent form explains the study's purpose, procedures, risks, benefits and provides other important information, such as the study team's contact information.

  4. Step
    4

    Participate

    If you decide to participate in a clinical trial or study, the research team will keep you informed of the study requirements and what you will need to do to throughout the study. For some trials or studies, your health care provider may work with the research team to ensure there are no conflicts with other medications or treatments.