NCT02610543终止2 期
A Randomized, Double-blind, Placebo-controlled, Proof-of-concept Study to Evaluate the Efficacy of UCB5857 Over 12 Weeks in Subjects With Primary Sjögren's Syndrome
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- UCB Celltech
- 入组人数
- 27
- 试验地点
- 14
- 主要终点
- Change from Baseline to Week 12 in the European League Against Rheumatism Sjögren's Syndrome Disease Activity Index (ESSDAI)
研究概览
简要总结
This is a Phase 2, multicenter, double-blind, placebo-controlled, 12-week proof-of-concept study to assess the efficacy, safety, and tolerability of UCB5857 in subjects with primary Sjögren's Syndrome (pSS).
The primary objective of this study is to evaluate the efficacy on overall disease activity and safety of UCB5857 added to current treatment relative to placebo in subjects with pSS.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
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 1 (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 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 (American-European Consensus Group) criteria for Primary Sjӧgren's Syndrome
- •Subject must have a serum test positive for anti-SSA/Ro (Ro-52 or Ro-60) and/or anti SSB/La autoantibodies
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)
- •o 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 (HBV) or hepatitis C (HCV)
- •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 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 <10.0 g/dL, or white blood cell (WBC) <2000 /mm^3, or absolute neutrophil count <1000 /mm^3, or platelets <100,000 /mm^3 at Screening (Visit 1)
- •Subject has a history of cancer
研究组 & 干预措施
UCB5857
Experimental
UCB5857 once daily for 12 weeks
干预措施: UCB5857 (Drug)
Placebo
Placebo Comparator
Placebo once daily for 12 weeks
干预措施: Placebo (Drug)
结局指标
主要结局
Change from Baseline to Week 12 in the European League Against Rheumatism Sjögren's Syndrome Disease Activity Index (ESSDAI)
时间窗: Week 12
The ESSDAI is a physician administered questionnaire containing 12 organ-specific domains designed to measure disease activity
次要结局
- Change from Baseline to Week 4 in the European League Against Rheumatism Sjögren's Syndrome Disease Activity Index (ESSDAI)(Week 4)
- Change from Baseline to Week 8 in the European League Against Rheumatism Sjögren's Syndrome Disease Activity Index (ESSDAI)(Week 8)
- Change from Baseline to Week 4 in the EULAR Sjögren's Syndrome Patient Response Index (ESSPRI)(Week 4)
- Change from Baseline to Week 8 in the EULAR Sjögren's Syndrome Patient Response Index (ESSPRI)(Week 8)
- Change from Baseline to Week 4 in the stimulated salivary flow(Week 4)
- Change from Baseline to Week 12 in the EULAR Sjögren's Syndrome Patient Response Index (ESSPRI)(Week 12)
- Change from Baseline to Week 8 in the stimulated salivary flow(Week 8)
- Change from Baseline to Week 12 in the stimulated salivary flow(Week 12)
- Change from Baseline to Week 4 in the unstimulated salivary flow(Week 4)
- Change from Baseline to Week 8 in the unstimulated salivary flow(Week 8)
- Change from Baseline to Week 12 in the unstimulated salivary flow(Week 12)
- Change in sum total tear secretion from Baseline to Week 12 measured by Schirmer´s I test(without anesthesia)(Week 12)
研究者
研究点 (14)
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