EUCTR2014-004523-51-GB进行中（未招募）1 期
A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PROOF-OF-CONCEPT STUDY TO EVALUATE THE EFFICACY AND SAFETY OF UCB5857 OVER 12 WEEKS IN SUBJECTS WITH PRIMARY SJOGREN’S SYNDROME
CB Celltech, UK0 个研究点目标入组 58 人开始时间: 2015年4月1日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 58
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
- •Subject must be between 18 years and 75 years of age
- •Women of childbearing potential must agree to use a highly effective method of birth control during the study and for a period of 3 months after their final dose of study drug. Women not agreeing to use birth control must be of non-childbearing potential defined as: permanently sterile, congenitally sterile or postmenopausal for at least 2 years prior to Screening (Visit 1). Women of childbearing potential are required to have a serum pregnancy test taken at Screening (Visit 1), which is confirmed to be negative by urine testing prior to the first dose of study drug at Week 0 (Visit 2).
- •Male subjects with a partner of childbearing potential must be willing to use a condom when sexually active during the study and for 3 months after the last dose of the study drug. In addition female partner of childbearing potential of male subject must be willing to use a highly effective method of contraception for duration of study and for 3 months after last dose of study drug.
- •Subject must meet the 2002 AECG criteria for Primary Sjogren’s Syndrome
- •Subject must have a serum test positive for anti-SSA/Ro (Ro-52 or Ro-60) and/or anti SSB/La autoantibodies
- •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 50
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 8
排除标准
- •Subject has a diagnosis of any other autoimmune disease, ie, secondary Sjögren’s syndrome (eg, rheumatoid arthritis, systemic lupus erythematosus)
- •Subject has a diagnosis of any other sicca syndrome (eg, history of head and neck radiation treatment, sarcoidosis chronic graft-versus-host disease)
- •Subject has, significant fibromyalgia syndrome as defined by the American College of Rheumatology 2010 classification criteria.
- •Subject has, significant depression as defined by the 5th edition of the Diagnostic and Statistical Manual of Mental Disorders.
- •Subject has oral candidiasis
- •Subject is female and is breast-feeding, pregnant, or plans to become pregnant or to start breastfeeding during the study or within 3 months after the final dose of the investigational medicinal product (IMP)
- •Subject has evidence of an immunosuppressive state, including human immunodeficiency virus (HIV) infection, hypogammaglobulinemias, T-cell deficiencies, or human T-cell leukemia virus type 1 (HTLV-1)
- •*Positive testing for HIV-1/2 at screening (Visit 1)
- •Subject has a history of chronic infections, including but not limited to concurrent acute or chronic viral hepatitis B or C or tuberculosis (TB).
- •*Positive testing for HBV at Screening (Visit 1)
- •*Positive testing for HCV at Screening (Visit 1)
- •A subject with a history of a recent serious or life-threatening infection or any current signs or symptoms that may indicate a significant infection at Screening (Visit 1) to randomization, as per the Investigator’s clinical judgment is also excluded. Subject must have completed any prior anti-infective therapy prior to the first dose of study drug with the exception of anti-infectives taken specifically for the treatment of acne, rosacea, onychomycosis, or vaginal yeast infections; for the prophylaxis of urinary tract infections; or prophylaxis for pre-surgical or pre-procedural reasons (including dental procedures). Note: minocycline may not be used for these purposes
- •Subject is, in the opinion of the Investigator, at a particularly high risk of significant infection due to their lifestyle and/or occupation
- •Subject has received intranasal influenza vaccine within the 8 weeks prior to Screening (Visit 1)
- •Subject has significant hematologic abnormalities of hemoglobin <8.0g/dL, or white blood cell (WBC) <2000/mm3, or absolute neutrophil count <1000/mm3, or platelets <30,000/mm3 at Screening (Visit 1)
- •Subject has a history of cancer
研究者
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