EUCTR2021-005911-30-NL进行中（未招募）1 期
A Phase 2, Randomized, Placebo-controlled, Parallel Group, Double-blind, Proof-of-concept Study to Evaluate the Safety and Efficacy of Intravenous Efgartigimod in Adult Participants With Primary Sjögren’s Syndrome
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- argenx BV
- 入组人数
- 30
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Participants are eligible to be included in the study only if all of the following criteria apply:
- •- Is at least the legal age of consent for clinical trials when signing the informed consent form
- •- Is capable of providing signed informed consent and complying with protocol requirements
- •- Agrees to use contraceptive measures consistent with local regulations and measures described in the protocol
- •- Meets the following criteria: ACR/EULAR 2016 pSS who met criteria =7 years before screening;
- •ESSDAI =5; Ro/SS-A positive; Residual salivary flow (UWSF rate >0 and/or SWSF rate >0.10)
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 27
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 3
排除标准
- •Participants will be excluded from the study if any of the following criteria apply:
- •- Known autoimmune disease or any medical condition that, in the investigator’s judgment, would interfere with an accurate assessment of clinical symptoms of pSS or puts the participant at undue risk
- •- History of malignancy unless considered cured by adequate treatment with no evidence of recurrence for =3 years before the first administration of IMP. Adequately treated participants with the following cancers may be included at any time: Basal cell or squamous cell skin cancer; Carcinoma in situ of the cervix; Carcinoma in situ of the breast; Incidental histological finding of prostate cancer (TNM stage T1a or T1b)
- •- Clinically significant uncontrolled active acute or chronic bacterial, viral, or fungal infection
- •- Positive serum test at screening for an active infection with any of the following: HBV that is indicative of an acute or chronic infection, unless associated with a negative HBsAg or negative HBV DNA test; HCV based on HCV antibody assay unless a negative RNA test is available; HIV based on test results of a CD4 count of <200 cells/mm3 that are associated with an AIDS-defining condition, HIV based on test results of a CD4 count of >200 cells/mm3 not adequately treated with antiviral therapy
- •- Clinically significant disease, recent major surgery (within 3 months of screening), or intention to have surgery during the study; or any other medical condition that, in the investigator’s opinion, would confound the results of the study or put the participant at undue risk
- •- Immunoglobulin G (IgG) levels cannot be below a certain threshold ( 4g/L)
- •- Positive covid test at study start
- •- Some of the medications such as vaccines with live components or medicines that may be prescribed for Sjogren’s syndrome cannot be taken either shortly before or during this study
- •- Current participation in another interventional clinical study or previously participation in an efgartigimod clinical study and treatment with =1 dose of IMP
- •- Known hypersensitivity to IMP or 1 of its excipients
- •- History (within 12 months of screening) of current alcohol, drug, or medication abuse as assessed by the investigator
- •- Pregnant or lactating state or intention to become pregnant during the study
- •- Secondary Sjögren’s syndrome overlap syndromes where another confirmed autoimmune rheumatic or systemic inflammatory condition is the primary diagnosis
- •- Chinese traditional medicine with known immunomodulatory action
- •A detailed list is provided in the protocol.
研究者
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