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A Phase 1, Randomized, Blinded, Single-Dose, Dose Escalation Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of MEDI7734 in Type I Interferon-Mediated Autoimmune Diseases (NCT02780674)

To evaluate the safety and tolerability of escalating, single subcutaneous doses of MEDI7734 in adult subjects with type I interferon-mediated autoimmune diseases.
  • Biological: MEDI7734
    Three subjects (cohort 1) and six subjects (cohort 2-5) will receive MEDI7734 for a total of 27 subjects.
    • Biological: Placebo
      One subject (cohort 1) and two subjects (cohort 2-5) will receive placebo, for a total of 9 subjects.
      Ages eligible for Study
      18 Years to 65 Years
      Genders eligible for Study
      All
      Accepts Healthy Volunteers
      No
      Inclusion Criteria:
      • Age 18-65 years old
      • Diagnoses of dematomyositis, polymyositis, Sjogren's syndrome, systemic lupus erythematosus and/or systemic sclerosis based on standard criteria.
      • Weight 40-120kg
      • Stable disease such that in the opinion of the investigator it is unlikely that a change in subject's therapeutic regimen would be required during the subsequent 3 months. Key
      Exclusion Criteria:
      • History of a hypersensitivity reaction or anaphylaxis to a previous mAb or human immunoglobulin therapy.
      • Chronic hepatitis B, chronic hepatitis C, or HIV infection.
      • History of latent or active tuberculosis (TB), or a positive QuantiFERON®-TB Gold test at screening.
      • Herpes zoster infection within 3 months before randomization
      • Any of the following medications within 6 months of Day 1: cyclophosphamide, leflunomide > 20 mg/day, abatacept.
      • Receipt of a mAb within 5 published half-lives prior to Day 1.
      • Receipt of rituximab or an experimental B-cell depleting mAb within 6 months of Day 1.
      • Receipt of rituximab or an experimental B-cell depleting mAb without return of CD19 or CD20 count to above the lower limit of normal.
      • Receipt of alemtuzumab, bone marrow transplantation, stem cell transplantation, total lymphoid irradiation, or T-cell vaccination therapy -
      MEDI7734 is a human monoclonal antibody that binds to and causes temporary depletion of plasmacytoid dendritic cells (pDCs), a type of white blood cell. The objectives of this study are to evaluate the safety, drug levels, and pDC levels in subjects who are given a single injection of MEDI7734 or a placebo.

      The study will be conducted in subjects with at least one of the five following autoimmune diseases: dermatomyositis, polymyositis, Sjogren's syndrome, systemic lupus erythematosus, or systemic sclerosis.

      After a screening period, subjects will be randomized in a 3:1 ratio to receive a single dose of MEDI7734 or matching placebo, administered as a subcutaneous (under the skin) injection. After that, subjects will be evaluated periodically at the study site over at least the next 85 days.

      7 locations

      United States (7)
      • Research Site
        Not specified
        Anniston, Alabama, United States, 36207
      • Research Site
        Not specified
        Birmingham, Alabama, United States, 35294
      • Research Site
        Not specified
        Danbury, Connecticut, United States, 6810
      • Research Site
        Not specified
        Jacksonville, Florida, United States, 32216
      • Research Site
        Not specified
        Miami Springs, Florida, United States, 33166
      • Research Site
        Not specified
        Duncansville, Pennsylvania, United States, 16635
      • Research Site
        Not specified
        DeBary, Florida, United States, 32713
      Status:
      completed
      Type:
      Interventional
      Phase:
      Start:
      25 August, 2016
      Updated:
      31 January, 2018
      Participants:
      36
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