EUCTR2014-004523-51-ES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6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 an acceptable 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 surgically sterile (hysterectomy/oophorectomy or tubal ligation) 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)
- •?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 and Ro-60) and/or anti SSB/La autoantibodies
- •?Subject must have an ESSDAI score of ?5
- •?Subject must have an unstimulated salivary flow rate of > 0mL/5 minutes
- •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, in the opinion of the Investigator, significant fibromyalgia syndrome
- •?Subject has, in the opinion of the Investigator, significant depression
- •?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)
- •?Subject has a history of chronic infections, including but not limited to concurrent acute or chronic viral hepatitis B or C. 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, except the following treated cancers: Sjögren?s syndrome associated lymphoma, cervical carcinoma in situ, basal cell carcinoma, or dermatological squamous cell carcinoma
研究者
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