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
- Neuromyelitis opticaNMO10007951
- Registration Number
- NL-OMON46416
- Lead Sponsor
- MedImmune LLC
- Brief Summary
Trial ended prematurely
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 3
1) Men and women 18 years or older with diagnosis of NMO/NMOSD.
2) Confirmation of NMO/NMOSD status:
a.) 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.
b.) 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) EDSS <= 7.5 (8 in special circumstances).
4) 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.
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 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:
a) Alemtuzumab
b) Total lymphoid irradiation
c) Bone marrow transplant
d) 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:
a) Natalizumab (Tysabri®)
b) Cyclosporin
c) Methotrexate
d) Mitoxantrone
e) Cyclophosphamide
f) Tocilizumab
g) 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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Primary Endpoint:<br /><br>The primary endpoint is the time (days) from Day 1 to onset of an Adjudication<br /><br>Committee (AC)-determined NMO/NMOSD attack on or before Day 197. The definition<br /><br>of an NMO/NMOSD attack is the presence of a new symptom(s) or worsening of an<br /><br>existing symptom(s) related to NMO/NMOSD that meets at least ONE of the<br /><br>protocol-defined criteria for an NMO/NMOSD attack. </p><br>
- Secondary Outcome Measures
Name Time Method