None listed
Conditions
Interventions
Randomized-controlled Period
• Treatment Arm 1: 300 mg IV MEDI-551 on Day 1 and Day 15
• Treatment Arm 2: IV Placebo on Day 1 and Day 15
Additionally, all subjects entering the RCP will be tr
Sponsors
MedImmune, LLC, una subsidiaria perteneciente en su totalidad a AstraZeneca,
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. Age 18 years or more. 2. Written informed consent. 3. One of the following: a. Positive serum anti-AQP4-IgG result at screening and a documented history of one or more NMO/NMOSD acute relapses that required rescue therapy within the last year, or 2 or more NMO/NMOSD acute relapses that required rescue therapy within 2 years prior to screening; OR b. Negative serum anti-AQP4-IgG result at screening without evidence of brain lesion consistent with MS and meets the clinical criteria for NMO and a documented history of one or more NMO acute relapses that required rescue therapy within the last year, or 2 or more NMO acute relapses that required rescue therapy within 2 years prior to screening. 4. Subjects who have had a relapse immediately prior to screening or who have a relapse during the screening period must have at least 2 weeks in which their relapse symptoms are stable or improving prior to randomization. 5. Expanded Disability Status Scale score at randomization less than or equal to 7.5. 6. Females of childbearing potential who are sexually active with a nonsterilized male partner must use a highly effective method of contraception. 7. Nonsterilized males. 8. Sterilized males, 9. Willing to forego other forms of investigational treatment for NMO/NMOSD during the study 10. Ability and willingness to complete the study Please, refer to the protocol for more information.
Exclusion criteria
Exclusion criteria: 1. Any condition that, in the opinion of the investigator, would interfere with the evaluation or administration of the investigational product. 2. Concurrent/previous enrollment in another clinical study involving an investigational treatment 3. An estimated glomerular filtration rate of 2.5 × upper limit of normal (ULN) d. Alanine transaminase (ALT) > 2.5 × ULN e. Total bilirubin > 1.5 × ULN (unless due to Gilbert’s syndrome) f. Platelet count 8% at screening (subjects with diabetes only) Exclusion Criteria Related to Concomitant Medications (See protocol) Exclusion Criteria Related to NMO and Other Diseases (See protocol) Exclusion Criteria Related to Infection and Malignancy Risk Factors (See protocol) For more information, see protocol.
Countries
Argentina, Australia, Brazil, Bulgaria, Canada, Colombia, Czech Republic, Estonia, Germany, Israel, Japan, Korea South, Mexico, Modalvia, New Zealand, Poland, Russian Federation, Taiwan, Thailand, Turkey, Ukraine, United States
Contacts
Public ContactAndres Bayona
PPD Peru S.A.C.
Outcome results
None listed