Immunologic Response to Secukinumab in Plaque Psoriasis
2020年8月31日 更新者：University of California, San Francisco
Characterization of the Response to Secukinumab in Plaque Psoriasis Using Novel Immunologic and Genetic Profiling
This is a single-arm, open-label study, which will examine the effect of secukinumab on the immunologic and genetic environment within psoriatic lesions.
研究概览
详细说明
Quantitative analysis of the immunologic changes in immune cell populations will be performed after secukinumab treatment in 15 patients at weeks 2, 4, and 12 compared to baseline week 0. The immunologic profiles in psoriasis patients will also be compared to healthy control skin surgical discard specimens (n=10).
The number of differentially expressed genes in each cell population will be quantified by RNA-seq at weeks 2, 4, 12 after secukinumab compared to baseline.
研究类型
介入性
注册 (实际的)
15
阶段
- 第四阶段
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
-
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California
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San Francisco、California、美国、94118
- UCSF Psoriasis and Skin Treatment Center
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 及以上 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- Ability to provide written informed consent and comply with the protocol.
- At least 18 years of age.
- Diagnosis of predominately plaque psoriasis for at least 6 months prior to enrollment.
- Subject is considered a candidate for phototherapy or systemic therapy
- PASI ≥ 12
- PGA ≥ 3
- Subject has a negative Quantiferon Gold, or if positive undergoes CXR. If CXR negative, subject initiated prophylactic therapy with isoniazid for a course of 9 months with one month of therapy completed prior to first dose of secukinumab.
- Subject is unlikely to conceive (male, post-menopausal, or using adequate oral contraceptive therapy or IUD).
- Physical exam within clinically acceptable limits.
Exclusion Criteria:
- Subject is unable to provide written informed consent or comply with the protocol.
- Subject is younger than 18 years of age.
- Subject has predominately non-plaque form of psoriasis.
- Subject with mild psoriasis (PASI<12 and PGA<3) or is not a candidate for phototherapy or systemic treatments.
- Subject has drug-induced psoriasis.
- Subject with current, or a history of, severe psoriatic arthritis well controlled on current therapy.
- Subjects with a serum creatinine level exceeding 176.8 μmol/L (2.0 mg/dl).
- Screening total white blood cell (WBC count) < 2,500/μl, platelets < 100,000/μl, neutrophils < 1,500/μl, or hemoglobin <8.5 g/dl.
- Evidence of active tuberculosis infection as defined by a positive QuantiFERON TB-Gold test (QFT) with a positive chest X-ray at screening, or untreated latent tuberculosis defined by positive QFT with a negative chest X-ray without prophylactic therapy with isoniazid for a course of 9 months with one month of therapy completed prior to first dose of secukinumab.
- History of an ongoing, chronic or recurrent infectious disease including past medical history record of HIV, hepatitis B or hepatitis C.
- Subjects possess other diagnoses that, in the investigator's opinion, preclude him/her from safely participating in this study or interfere with the evaluation of the subject's psoriasis.
- History of known or suspected intolerance to any of the ingredients of the investigational study product.
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：基础科学
- 分配：不适用
- 介入模型：单组作业
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：Secukinumab
All subjects will receive Secukinumab 300mg SQ at weeks 0, 1, 2, 3, 4, and every 4 weeks thereafter until week 48.
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Secukinumab 300mg SQ at weeks 0, 1, 2, 3, 4, and every 4 weeks thereafter until week 48.
Skin biopsy procedures will be performed at weeks 0, 2, 4, and 12.
其他名称：
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研究衡量的是什么？
主要结果指标
结果测量 |
大体时间 |
|---|---|
|
Change in Percentage of CD4+ T Effector Cells Expressing IL17 Compared to Baseline
大体时间：Baseline to Week 2
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Baseline to Week 2
|
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Change in Percentage of CD4+ T Effector Cells Expressing IL17 Compared to Baseline
大体时间：Baseline to Week 4
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Baseline to Week 4
|
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Change in Percentage of CD4+ T Effector Cells Expressing IL17 Compared to Baseline
大体时间：Baseline to Week 12
|
Baseline to Week 12
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Change in Number of Differentially Expressed Genes in CD4+ Effectors Compared to Baseline Across All Participants
大体时间：Baseline to Week 2
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by RNA-seq
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Baseline to Week 2
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Change in Number of Differentially Expressed Genes in CD4+ Effectors Compared to Baseline
大体时间：Baseline to Week 4
|
by RNA-seq
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Baseline to Week 4
|
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Change in Number of Differentially Expressed Genes in CD4+ Effectors Compared to Baseline
大体时间：Baseline to Week 12
|
by RNA-seq
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Baseline to Week 12
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Change in Number of Differentially Expressed Genes in CD4+ T Regs Compared to Baseline
大体时间：Baseline to Week 2
|
by RNA-seq
|
Baseline to Week 2
|
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Change in Number of Differentially Expressed Genes in CD4+ T Regs Compared to Baseline
大体时间：Baseline to Week 4
|
by RNA-seq
|
Baseline to Week 4
|
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Change in Number of Differentially Expressed Genes in CD4+ T Regs Compared to Baseline
大体时间：Baseline to Week 12
|
by RNA-seq
|
Baseline to Week 12
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Change in Number of Differentially Expressed Genes in CD8+ T Effectors Compared to Baseline
大体时间：Baseline to Week 2
|
by RNA-seq
|
Baseline to Week 2
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Change in Number of Differentially Expressed Genes in CD8+ T Effectors Compared to Baseline
大体时间：Baseline to Week 4
|
by RNA-seq
|
Baseline to Week 4
|
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Change in Number of Differentially Expressed Genes in CD8+ T Effectors Compared to Baseline
大体时间：Baseline to Week 12
|
by RNA-seq
|
Baseline to Week 12
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2016年10月1日
初级完成 (实际的)
2018年12月1日
研究完成 (实际的)
2018年12月1日
研究注册日期
首次提交
2015年10月16日
首先提交符合 QC 标准的
2015年10月28日
首次发布 (估计)
2015年10月30日
研究记录更新
最后更新发布 (实际的)
2020年9月16日
上次提交的符合 QC 标准的更新
2020年8月31日
最后验证
2020年8月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.