PER-079-14已完成未知

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

MedImmune, LLC, una subsidiaria perteneciente en su totalidad a AstraZeneca,0 个研究点目标入组 9 人开始时间: 2015年4月21日最近更新: 2023年9月4日

适应症

试验速览

暂无简介。

•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.

•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 < 60 mL/min at risk of developing nephrogenic systemic fibrosis
•4. Lactating or pregnant females or females who intend to become pregnant anytime
•5. Known history of allergy or reaction to any component of the investigational product formulation or history of anaphylaxis following any biologic therapy
•6. Evidence of alcohol, drug, or chemical abuse
•7. Major surgery within 8 weeks prior to signing the ICF
•8. Spontaneous or induced abortion
•9. Subjects who are unable to undergo an MRI scan
•10. At screening, any of the following:
•c. Aspartate transaminase (AST) > 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 < 75,000/μL (or < 75 × 109/L)
•g. Hemoglobin < 8 g/dL (or < 80 g/L)
•h. Glycosylated hemoglobin (HbA1c) > 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.

发起方

MedImmune, LLC, una subsidiaria perteneciente en su totalidad a AstraZeneca,