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About
The objective of this study is to evaluate the efficacy, safety, pharmacodynamic, pharmacokinetic, and immunogenic profiles of satralizumab, compared with placebo, in addition to baseline immunosuppressive treatment in participants with NMO and NMOSD.
Enrollment
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Inclusion criteria
Patients must be diagnosed as having either neuromyelitis optica (NMO) or NMO spectrum disorder (NMOSD), defined as the following:
Clinical evidence of at least 2 documented relapses (including first attack) in the last 2 years prior to screening, at least one of which has occurred in the 12 months prior to screening
EDSS score from 0 to 6.5 inclusive at screening
Age 12 to 74 years, inclusive at the time of informed consent
One of the following baseline treatments must be at stable dose as a monotherapy for 8 weeks prior to baseline: Azathioprine; Mycophenolate mofetil; Oral corticosteroids. For participants aged 12 to 17 years, either of the following baseline treatments for relapse prevention can be allowed: Azathioprine + oral corticosteroids; Mycophenolate mofetil + oral corticosteroids
Ability and willingness to provide written informed consent and to comply with the requirements of the protocol
For adolescents who may be enrolled after the end of the double-blind period, the inclusion criterion 2 is as follows (other criteria are same): Clinical evidence of at least 2 documented relapses (including first attack) prior to screening.
Exclusion criteria
Exclusion criteria related to previous or concomitant therapy:
Any previous treatment with IL-6 inhibitory therapy (e.g. tocilizumab), alemtuzumab, total body irradiation or bone marrow transplantation at any time
Any previous treatment with anti-CD20, eculizumab, belimumab, interferon, natalizumab, glatiramer acetate, fingolimod, teriflunomide or dimethyl fumarate within 6 months prior to baseline
Any previous treatment with anti-CD4, cladribine or mitoxantrone within 2 years prior to baseline
Treatment with any investigational agent within 3 months prior to baseline
Exclusions for general safety:
Pregnancy or lactation
For patients of reproductive potential, a positive result from a serum pregnancy test at screening, or not willing to use reliable means of contraception (physical barrier [patient or partner] in conjunction with a spermicidal product, contraceptive pill, patch, injectables, intrauterine device or intrauterine system) during the treatment period and for at least 3 months after the last dose of study drug
Any surgical procedure (except for minor surgeries) within 4 weeks prior to baseline
Evidence of other demyelinating disease or progressive multifocal leukoencephalopathy (PML)
Evidence of serious uncontrolled concomitant diseases that may preclude patient participation, such as: other nervous system disease, cardiovascular disease, hematologic/hematopoiesis disease, respiratory disease, muscular disease, endocrine disease, renal/urologic disease, digestive system disease, congenital or acquired severe immunodeficiency
Known active infection (excluding fungal infections of nail beds or caries dentium) within 4 weeks prior to baseline
Evidence of chronic active hepatitis B or C
History of drug or alcohol abuse within 1 year prior to baseline
History of diverticulitis that, in the Investigator's opinion, may lead to increased risk of complications such as lower gastrointestinal perforation
Evidence of active tuberculosis (TB; excluding patients receiving chemoprophylaxis for latent TB infection)
Evidence of active interstitial lung disease
Receipt of any live or live attenuated vaccine within 6 weeks prior to baseline
History of malignancy within the last 5 years, including solid tumors, hematologic malignancies and in situ carcinoma (except basal cell and squamous cell carcinomas of the skin, or in situ carcinoma of the cervix uteri that have been completely excised and cured)
History of severe allergic reaction to a biologic agent (e.g. shock, anaphylactic reactions)
Active suicidal ideation within 6 months prior to screening, or history of suicide attempt within 3 years prior to screening
Following laboratory abnormalities at screening*.
For adolescents who may be enrolled after the end of the double-blind period, the annotation in the exclusion criterion 20 is as follows (other criteria are same): * If retest is conducted, the last value of retest before baseline must meet study criteria
Primary purpose
Allocation
Interventional model
Masking
85 participants in 2 patient groups, including a placebo group
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Data sourced from clinicaltrials.gov
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