A Double-masked, Placebo-controlled Study With Open-label Period to Evaluate the Efficacy and Safety of MEDI-551 in Adult Subjects With Neuromyelitis Optica and Neuromyelitis Optica Spectrum Disorders
- Conditions
- euromyelitis Optica and Neuromyelitis Optica Spectrum Disorders
- Registration Number
- JPRN-jRCT2080223977
- Lead Sponsor
- MedImmune LLC
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- recruiting
- Sex
- All
- Target Recruitment
- Not specified
Diagnosis of NMO/NMOSD
- 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
- Able and willing to give written informed consent and comply with the requirements of the study protocol
- EDSS <= 7.5 (8 in special circumstances)
- 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
- Lactating and pregnant females
- Treatment with any investigational agent within 4 weeks of screening
- Known history of a severe allergy or reaction to any component of the investigational product formulation or history of anaphylaxis following any biologic therapy.
- Known active severe bacterial, viral, or other infection or any major episode of infection requiring hospitalization.
- History of alcohol, drug, or chemical abuse, or a recent history of such abuse < 1 year prior to randomization
- 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
- Receipt of rituximab or any experimental B-cell depleting agent within 6 months prior screening and B-cells below the lower limit of normal.
- Receipt of IVIG within 1 month prior to randomization.
- 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
- History of Hepatitis B and/or Hepatitis C (Hep B/C at screening)
- Known history of a primary immunodeficiency (congenital or acquired) or an underlying condition such as human immunodeficiency virus (HIV) infection
- 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
- 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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method