A Safety and Effectiveness Study of CNTO 1275 in Patients With Moderate to Severe Plaque-type Psoriasis
2015年3月31日 更新者：Centocor, Inc.
A Phase II, Randomized, Double-blind, Placebo-controlled, Parallel Study of Single and Multiple Dose Regimens With Subcutaneous CNTO 1275 (Human Monoclonal Antibody to IL-12) in Subjects With Moderate to Severe Psoriasis
The purpose of this study is to evaluate the efficacy and safety of initial single and multiple subcutaneous injections of CNTO 1275 in the treatment of patients with moderate to severe plaque psoriasis.
研究概览
详细说明
This is a randomized (the study medication is assigned by chance), double blind (neither physician nor patient knows the treatment that the patient receives), parallel-group, multicenter study to determine the effectiveness and safety of two different doses of CNTO 1275 administered subcutaneously one time or as multiple doses as compared with placebo in patients with moderate to severe plaque-type psoriasis (the most common type of psoriasis).
The dose of CNTO 1275 will be 45 or 90 mg administered subcutaneously once or as four weekly doses.
Patients who inadequately respond to their treatment may receive one additional dose.
Patients will be monitored for the safety throughout the study.
研究类型
介入性
注册 (实际的)
320
阶段
- 阶段2
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:
- Have had a diagnosis of plaque-type psoriasis at least 6 months
- Plaque-type psoriasis covering at least 10% of total body surface areas
- Psoriasis area-and-severity index score of 12 or greater
- Considered by treating dermatologist to be a candidate for phototherapy or systemic treatment of psoriasis
- Women of childbearing potential and all men must agree to use adequate birth control measures
- Have no history of latent or active tuberculosis
Exclusion Criteria:
- Currently have nonplaque forms of psoriasis or drug-induced psoriasis
- Women who are pregnant or nursing, or men and women planning pregnancy while enrolled in the study
- Patients who have a history of chronic or recurrent infectious disease or who have or have had a serious infection requiring hospitalization or intravenous antibiotics within the previous 2 months
- Patients who have or ever have had a nontuberculous mycobacterial infection or opportunistic infection
- Patients known to be infected with human immunodeficiency virus, hepatitis B, or hepatitis C
- Patients who have current signs or symptoms of severe, progressive, or uncontrolled renal, hepatic, hematological, gastrointestinal, endocrine, pulmonary, cardiac, neurologic, cerebral, or psychiatric disease
- Have any known malignancy or have a history of malignancy within the previous 5 years (with the exception of basal cell carcinoma of the skin that has been treated with no evidence of recurrence)
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：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：双倍的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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安慰剂比较：Group I (Placebo)
Patients in the placebo group will receive placebo at Weeks 0, 1, 2, 3, and 16.
At week 20, all patients will receive a single dose of ustekinumab 90 mg.
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Patients in the placebo group will receive placebo medication.
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实验性的：Group II (Ustekinumab 45 mg)
Patients will receive single dose ustekinumab at Week 0 and placebo at Weeks 1, 2, and 3.
At Week 16, patients with Physician's Global Assessment (PGA) greater than or equal to 3 will receive ustekinumab 45 mg.
At week 20, all patients will receive placebo.
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Patients in the placebo group will receive placebo medication.
Patients will receive subcutaneous injections of ustekinumab (45 or 90 mg).
其他名称：
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实验性的：Group III (Ustekinumab 90 mg)
Patients will receive 90 mg single dose ustekinumab at Week 0 and placebo at Weeks 1, 2, and 3.
At Week 16 patients with PGA greater than or equal to 3 will receive ustekinumab 90 mg.
At week 20, all patients will receive placebo.
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Patients in the placebo group will receive placebo medication.
Patients will receive subcutaneous injections of ustekinumab (45 or 90 mg).
其他名称：
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实验性的：Group IV
Patients will receive 45 mg of ustekinumab at Weeks 0, 1, 2, and 3.
At Week 16, patients with Physician's Global Assessment (PGA) greater than or equal to 3 will receive ustekinumab 45 mg.
At week 20, all patients will receive placebo.
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Patients will receive subcutaneous injections of ustekinumab (45 or 90 mg).
其他名称：
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实验性的：Group V
Patients will receive 90 mg of ustekinumab at Weeks 0, 1, 2, and 3.
At Week 16 patients with Physician's Global Assessment (PGA) greater than or equal to 3 will receive ustekinumab 90 mg.
At week 20, all patients will receive placebo.
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Patients will receive subcutaneous injections of ustekinumab (45 or 90 mg).
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 |
措施说明 |
大体时间 |
|---|---|---|
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Number of Participants Who Achieved Psoriasis Area and Severity Index (PASI) 75% Improvement at Week 12
大体时间：Week 12
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Psoriasis Area and Severity Index (PASI)(0 [ best] -72 [worst]) score at Week 12.
This is a test of how bad a person's psoriasis is.
The combination of redness, scaling, and thickness, as well as overall body involvement determine the PASI score.
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Week 12
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Number of Participants Who Achieved Physician's Global Assessment (PGA) Score of Clear (1) or Excellent (2) at Week 12
大体时间：Week 12
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Number of participants achieving a physician global assessment (PGA)(1 [best] to 6 [worst]) score of clear or excellent at Week 12.
The PGA is used to determine the participants psoriasis lesions overall at a given time point.
Overall lesions will be graded for induration, erythema, and scaling.
The sum of the 3 scales will be divided by 3 to obtain a final PGA score.
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Week 12
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Number of Participants Who Achieved Psoriasis Area Severity Index (PASI) 75% Improvement at Week 32
大体时间：Week 32
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Psoriasis Area and Severity Index (PASI)(0 [ best] -72 [worst]) score at Week 32 for participants who were not retreated at Week 16.
This is a test of how bad a person's psoriasis is.
The combination of redness, scaling, and thickness, as well as overall body involvement determine the PASI score.
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Week 32
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Number of Participants Who Achieved Psoriasis Area Severity Index (PASI) 75% Improvement (0-72) at Week 28
大体时间：Week 28
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Psoriasis Area and Severity Index (PASI)(0 [ best] -72 [worst]) score at Week 28 for participants who were retreated at Week 16.
This is a test of how bad a person's psoriasis is.
The combination of redness, scaling, and thickness, as well as overall body involvement determine the PASI score.
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Week 28
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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。
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
一般刊物
- Ghosh S, Gensler LS, Yang Z, Gasink C, Chakravarty SD, Farahi K, Ramachandran P, Ott E, Strober BE. Ustekinumab Safety in Psoriasis, Psoriatic Arthritis, and Crohn's Disease: An Integrated Analysis of Phase II/III Clinical Development Programs. Drug Saf. 2019 Jun;42(6):751-768. doi: 10.1007/s40264-019-00797-3. Erratum In: Drug Saf. 2019 Apr 22;:
- Krueger GG, Langley RG, Leonardi C, Yeilding N, Guzzo C, Wang Y, Dooley LT, Lebwohl M; CNTO 1275 Psoriasis Study Group. A human interleukin-12/23 monoclonal antibody for the treatment of psoriasis. N Engl J Med. 2007 Feb 8;356(6):580-92. doi: 10.1056/NEJMoa062382.
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
2003年11月1日
初级完成 (实际的)
2004年6月1日
研究完成 (实际的)
2005年3月1日
研究注册日期
首次提交
2006年4月28日
首先提交符合 QC 标准的
2006年4月28日
首次发布 (估计)
2006年5月3日
研究记录更新
最后更新发布 (估计)
2015年4月20日
上次提交的符合 QC 标准的更新
2015年3月31日
最后验证
2015年3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.