A Double-masked, Placebo-controlled Study With Open Label Period to Evaluate MEDI-551 in Neuromyelitis Optica and Neuromyelitis Optica Spectrum Disorders

Overview

  • Study type

    Interventional
  • Study phase

    II/III
  • Study IDs

  • Describes the nature of a clinical study. Types include:

    • Observational study — observes people and measures outcomes without affecting results.
    • Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
    • Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
  • During the early phases (phases 1 and 2), researchers assess safety, side effects, optimal dosages and risks/benefits. In the later phase (phase 3), researchers study whether the treatment works better than the current standard therapy. They also compare the safety of the new treatment with that of current treatments. Phase 3 trials include large numbers of people to make sure that the result is valid. There are also less common very early (phase 0) and later (phase 4) phases. Phase 0 trials are small trials that help researchers decide if a new agent should be tested in a phase 1 trial. Phase 4 trials look at long-term safety and effectiveness, after a new treatment has been approved and is on the market.

  • Site IRB
    • Rochester, Minnesota: 17-007383
    NCT ID: NCT02200770
    Sponsor Protocol Number: CD-IA-MEDI-551-1155

About this study

To compare the efficacy of MEDI-551 versus placebo in reducing the risk of an NMO/NMOSD attack in subjects with NMO/NMOSD.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. If you need assistance understanding the eligibility criteria, please contact the study team.

See eligibility criteria

Inclusion Criteria:

  1. Men and women 18 years or older with diagnosis of NMO/NMOSD
  2. Confirmation of NMO/NMOSD status:
    1. AQP4-IgG sero-positive NMO/NMOSD with at least one attack requiring rescue therapy in the last year or two attacks requiring rescue therapy in the last 2 years
    2. AQP4-IgG sero-negative NMO with at least one attack requiring rescue therapy in the last year or two attacks requiring rescue therapy in the last 2 years
  3. Able and willing to give written informed consent and comply with the requirements of the study protocol.
  4. EDSS <= 7.5 (8 in special circumstances)
  5. Men and women of reproductive potential must agree to use a highly effective method of birth control from screening to 6 months after final dose of the investigational product.

Exclusion Criteria:

  1. Lactating and pregnant females
  2. Treatment with any investigational agent within 4 weeks of screening
  3. Known history of a severe allergy or reaction to any component of the investigational product formulation or history of anaphylaxis following any biologic therapy.
  4. Known active severe bacterial, viral, or other infection or any major episode of infection requiring hospitalization.
  5. History of alcohol, drug, or chemical abuse, or a recent history of such abuse < 1 year prior to randomization
  6. Receipt of the following at any time prior to randomization:
    1. Alemtuzumab
    2. Total lymphoid irradiation
    3. Bone marrow transplant
    4. T-cell vaccination therapy
  7. Receipt of rituximab or any experimental B-cell depleting agent within 6 months prior screening and B-cells below the lower limit of normal.
  8. Receipt of IVIG within 1 month prior to randomization.
  9. Receipt of any of the following within 3 months prior to randomization:
    1. Natalizumab (Tysabri®)b.
    2. Cyclosporin
    3. Methotrexate
    4. Mitoxantrone
    5. Cyclophosphamide
    6. Tocilizumab
    7. Eculizumab
  10. History of Hepatitis B and/or Hepatitis C (Hep B/C at screening)
  11. Known history of a primary immunodeficiency (congenital or acquired) or an underlying condition such as human immunodeficiency virus (HIV) infection
  12. History of malignancies, apart from squamous cell or basal cell carcinoma of the skin treated with documented success of curative therapy > 3 months prior to randomization
  13. Any concomitant disease other than NMO/NMOSD that required treatment with oral or intravenous steroids at doses over 20 mg a day for over 21 days

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Eoin Flanagan, M.B., B.Ch.

Contact us for the latest status

Contact information:

Katie Dunlay

(507)538-5418

Dunlay.Katie@mayo.edu

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CLS-20387125

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