NL-OMON51721尚未招募3 期
A PHASE III, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTICENTER BASKET STUDY TO EVALUATE THE EFFICACY, SAFETY, PHARMACOKINETICS, AND PHARMACODYNAMICS OF SATRALIZUMAB IN PATIENTS WITH ANTI*N METHYL D ASPARTIC ACID RECEPTOR (NMDAR) OR ANTI*LEUCINE RICH GLIOMA INACTIVATED 1 (LGI1) ENCEPHALITIS - WN43174 CIELO
适应症
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 入组人数
- 6
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 12 至 64（—）
入选标准
- •Zie paraaf 5.1. en 5.2 in het protocol V2
- •Inclusion Criteria for All Participants
- •* Capable of giving signed informed consent as described in Appendix 1
- •* Reasonable exclusion of tumor or malignancy before baseline visit
- •(randomization)
- •* Onset of AIE symptoms, < 9 months before randomization
- •* Meet the definition of New Onset or Incomplete Responder AIE
- •- Has a stable (for at least 24 hours) mRS score = or > 2, measured at baseline
- •- Has received their first acute first-line therapy within 6 weeks prior to
- •randomization (baseline visit)
- •- Has not received prior treatment with rituximab or any other ISTs
- •(e.g., cyclophosphamide, mycophenolate mofetil, methotrexate,
- •cyclosporine, tacrolimus, azathioprine) or tocilizumab for AIE
- •- Incomplete Responder: defined as a participant with NMDAR or LGI1 AIE who
- •satisfies the following criteria:
- •o Has a stable (for at least 24 hours) mRS score = or > 2, measured at baseline
- •o Has received their first acute first-line therapy more than 6 weeks prior to
- •randomization (baseline visit).
- •o Has received immunotherapy beyond their first acute first-line therapy
- •* For women of childbearing potential: agreement to remain abstinent or use
- •adequate contraception during the treatment
- •period and for at least 3 months after the final dose of satralizumab or placebo
- •Additional Inclusion Criteria for the NMDAR AIE Cohort
- •In addition to the criteria outlined in Section 5.1.1, participants are
- •eligible to be included
- •in the NMDAR AIE cohort only if all of the following criteria apply:
- •* Age, > 12 years at the time of signing Informed Consent Form
- •* Signed Assent Form
- •* Diagnosis of probable or definite NMDAR encephalitis
- •Additional Inclusion Criteria for the LGI1 AIE Cohort
- •In addition to the criteria outlined in Section 5.1.1, participants are
- •eligible to be included
- •in the LGI1 AIE cohort only if all of the following criteria apply:
- •* Age, > 18 years at the time of signing Informed Consent Form
- •* Diagnosis of LGI1 encephalitis
排除标准
- •* Any untreated teratoma or thymoma at baseline visit (randomization). Teratoma
- •or thymoma detected prior to or during the screening period is allowed if
- •deemed cured after treatment (usually surgical removal) by 1 week prior to
- •* History of carcinoma or malignancy, unless deemed cured by adequate treatment
- •with no evidence of recurrence for = and > 5 years before screening (except
- •basal cell and
- •squamous cell carcinomas of the skin, or in situ carcinoma of the cervix uteri
- •have been completely excised and cured)
- •* For patients with NMDAR AIE, history of negative anti-NMDAR antibody in CSF
- •using a cell based assay within 9 months of symptom onset
- •* Historically known positivity to an intracellular antigen with high cancer
- •association
- •(e.g., anti-Hu, anti-Ma2, anti-CRMP5, anti-Yo, anti-amphiphysin, AMPA, mGluR5,
- •and GABAB) or GAD-65
- •* Historically known positivity to any cell surface neuronal antibodies other
- •NMDAR and LGI1 (e.g., caspr2, IgLON5, DPPX, GABAA, and neurexin-3a)
- •* Confirmed paraneoplastic encephalitis
- •* Confirmed central or peripheral nervous system demyelinating disease (e.g.,
- •multiple sclerosis, chronic inflammatory demyelinating polyneuropathy)
- •* Alternative causes of associated symptoms, including CNS infections, septic
- •encephalopathy, metabolic encephalopathy, epileptic disorders, mitochondrial
- •disease, Klein-Levin syndrome, Creutzfeldt-Jakob disease, rheumatologic
- •Reyes syndrome, or inborn errors of metabolism
- •* History of herpes simplex virus encephalitis in the previous 24 weeks
- •* Any previous/concurrent treatment with IL-6 inhibitory therapy (e.g.,
- •tocilizumab),
- •alemtuzumab, total body irradiation, or bone marrow transplantation
- •* Any previous treatment with anti-CD19 antibody, complement inhibitors,
- •neonatal Fc
- •receptor antagonists, anti*B-lymphocyte stimulator monoclonal antibody
- •(e.g., belimumab)
- •* Any previous treatment with T-cell depleting therapies, cladribine, or
- •mitoxantrone
- •* Treatment with oral cyclophosphamide within 1 year prior to baseline
- •* Treatment with any investigational drug (including bortezomib) within 24
- •weeks prior
- •to screening (or within 5 half-lives of the investigational drug; whichever is
- •* Concurrent use of more than one IST (e.g.. azathioprine, mycophenolate
- •mofetil, or
- •IV cyclophosphamide) as background therapy
- •The combination of an OCS with another permitted IST drug is allowed.
- •* Contraindication to all of the following rescue treatments: rituximab, IVIG,
- •corticosteroids, or IV cyclophosphamide
- •* Any surgical procedure, except laparoscopic surgery or minor surgeries
- •(defined as
- •procedures that require only local anesthesia or conscious sedation, i.e., do
- •require general, neuraxial or regional anesthesia, and are done on an
- •ambulatory/outpatient basis; e.g. toenail surgery, mole surgical excision,
- •tooth extraction), within 4 weeks prior to baseline, excluding surgery for
- •teratoma removal
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