BI 655066 / ABBV-066 (Risankizumab) in Moderate to Severe Plaque Psoriasis With Randomized Withdrawal and Re-treatment
2019年9月25日 更新者:AbbVie
BI 655066 / ABBV-066 (Risankizumab) Versus Placebo In a Multicenter Randomized Double-blind Study in Patients With Moderate to Severe Chronic Plaque Psoriasis Evaluating the Efficacy and Safety With Randomized Withdrawal and Re-treatment (IMMhance)
This was a multinational, multicenter, randomized, double-blind, placebo controlled study with randomized withdrawal and retreatment, evaluating the safety and efficacy of risankizumab 150 mg subcutaneous (SC) in participants with moderate to severe chronic plaque psoriasis.
研究概览
详细说明
In Part A1, eligible participants were randomized at Baseline at a ratio of 4:1, stratified by weight and prior exposure to tumor necrosis factor antagonists to receive double-blind (DB) risankizumab 150 mg or placebo at Weeks 0 and 4. In Part A2, participants randomized at Baseline to receive DB placebo then received risankizumab 150 mg at Weeks 16 (Part A2) and at Week 28 and every 12 weeks up to 88 weeks (Part B); participants randomized to risankizumab 150 mg continued to receive risankizumab 150 mg at Week 16.
Participants who received risankizumab in Part A and were nonresponders (sPGA >2) at Week 28 received risankizumab 150 mg at Week 28 and every 12 weeks up to 88 weeks (Part B).
In Part B, participants who received risankizumab in Part A and were responders (sPGA ≤2) at Week 28, were rerandomized at a ratio of 1:2 to receive DB risankizumab 150 mg or placebo at Week 28 and every 12 weeks up to 88 weeks (Part B).
Starting at Week 32, rerandomized participants who reached relapse (defined as sPGA ≥3) were switched to risankizumab 150 mg every 12 weeks.
研究类型
介入性
注册 (实际的)
507
阶段
- 第三阶段
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:
- Male or female participants. Woman of childbearing potential must be ready and willing to use highly effective methods of birth control per ICH M3 (R2) that result in a low failure rate of less than 1 percent per year when used consistently and correctly.
- Age ≥18 years at screening
- Have a diagnosis of chronic plaque psoriasis (with or without psoriatic arthritis) at least 6 months before the first administration of study drug. Duration of diagnosis may be reported by the participant.
- Have stable moderate to severe chronic plaque psoriasis with or without psoriatic arthritis at both Screening and Baseline (Randomization); Have an involved body surface area (BSA) ≥ 10% and Have a Psoriasis Area and Severity Index (PASI) ≥ 12 and Have a static Physician Global Assessment (sPGA) score of ≥ 3.
- Must be a candidate for systemic therapy or phototherapy for psoriasis treatment, as assessed by the investigator
- Signed and dated written informed consent prior to admission to the study and performance of any study procedures in accordance with Good Clinical Practice (GCP) and local legislation
Exclusion criteria:
- Participants with nonplaque forms of psoriasis (including guttate, erythrodermic, or pustular); current drug-induced psoriasis (including a new onset of psoriasis or an exacerbation of psoriasis from beta blockers, calcium channel blockers, or lithium); active ongoing inflammatory diseases other than psoriasis and psoriatic arthritis that might confound trial evaluations according to the investigators judgment.
- Previous exposure to ABBV-066
- Currently enrolled in another investigational study or less than 30 days (from screening) since completing another investigational study
- Use of any restricted medication as noted or any drug considered likely to interfere with the safe conduct of the study.
- Major surgery performed within 12 weeks prior to randomization or planned within 12 months after screening (e.g., hip replacement, removal aneurysm, stomach ligation).
- Known chronic or relevant acute infections such as active tuberculosis, human immunodeficiency virus (HIV), or viral hepatitis
- Any documented active or suspected malignancy or history of malignancy within 5 years prior to screening, except appropriately treated basal cell carcinoma or squamous cell carcinoma of the skin or in situ carcinoma of uterine cervix
- Evidence of a current or previous disease (including chronic alcohol or drug abuse), medical condition other than psoriasis, surgical procedure (i.e., organ transplant), medical examination finding (including vital signs and electrocardiogram [ECG]), or laboratory value at the screening visit outside the reference range that in the opinion of the Investigator, is clinically significant and would make the study participant unable to adhere to the protocol or to complete the trial, compromise the safety of the patient, or compromise the quality of the data.
- History of allergy/hypersensitivity to a systemically administered biologic agent or its excipients
- Women who are pregnant, nursing, or who plan to become pregnant while in the trial
- Previous enrolment in this trial
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:四人间
武器和干预
参与者组/臂 |
干预/治疗 |
---|---|
实验性的:Risankizumab
Participants randomized at Baseline to receive double-blind (DB) risankizumab 150 mg by subcutaneous injection at Weeks 0 and 4 (Part A1).
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Risankizumab administered by subcutaneous injection
其他名称:
|
安慰剂比较:Placebo
Participants randomized at Baseline to receive double-blind (DB) placebo by subcutaneous injection at Weeks 0 and 4 (Part A1).
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Placebo for risankizumab administered by subcutaneous injection
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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 |
---|---|---|
Percentage of Participants Achieving 90% Improvement Psoriasis Area and Severity Index (PASI) Score (PASI90) From Baseline to Week 16
大体时间:Baseline, Week 16
|
PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination.
The severity of each sign was assessed using a 5-point scale, where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked.
The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis.
PASI90 is defined as at least a 90% reduction in PASI score compared with the Baseline PASI score.
The percent reduction in score is calculated as (PASI score at Baseline - score at follow-up visit) / PASI score at Baseline * 100.
Non-responder imputation (NRI) was used for missing data.
|
Baseline, Week 16
|
Percentage of Participants Achieving Static Physician Global Assessment (sPGA) Score of Clear or Almost Clear at Week 16
大体时间:Week 16
|
The sPGA is an assessment by the investigator of the overall disease severity at the time of evaluation.
Erythema (E), induration (I), and desquamation (D) are scored on a 5-point scale ranging from 0 (none) to 4 (severe).
The sPGA ranges from 0 to 4, and is calculated as Clear (0) = 0 for all three; Almost clear (1) = mean >0, <1.5; Mild (2) = mean ≥1.5, <2.5; Moderate (3) = mean ≥2.5, <3.5; and Severe (4) = mean ≥3.5.
NRI was used for missing data.
|
Week 16
|
Percentage of Participants Achieving sPGA Score of Clear or Almost Clear at Week 52
大体时间:Week 52
|
The sPGA is an assessment by the investigator of the overall disease severity at the time of evaluation.
Erythema (E), induration (I), and desquamation (D) are scored on a 5-point scale ranging from 0 (none) to 4 (severe).
The sPGA ranges from 0 to 4, and is calculated as Clear (0) = 0 for all three; Almost clear (1) = mean >0, <1.5; Mild (2) = mean ≥1.5, <2.5; Moderate (3) = mean ≥2.5, <3.5; and Severe (4) = mean ≥3.5.
NRI was used for missing data.
|
Week 52
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
---|---|---|
第 16 周时 PASI 分数 (PASI75) 提高 75% 的参与者百分比
大体时间:第 16 周
|
PASI 是根据银屑病对体表面积的影响程度以及检查当天观察到的皮损和受影响面积的红斑(变红)、硬结(厚度)、脱屑(脱屑)的扩展程度的综合评分。
使用 5 分制评估每个体征的严重程度,其中 0 = 无症状,1 = 轻微,2 = 中度,3 = 明显,4 = 非常明显。
PASI 评分范围从 0 到 72,其中 0 表示没有牛皮癣,72 表示非常严重的牛皮癣。
PASI75 定义为 PASI 分数与基线 PASI 分数相比至少减少 75%。
分数降低百分比计算为(基线时的 PASI 分数 - 随访时的分数)/基线时的 PASI 分数 * 100。
NRI 用于缺失数据。
|
第 16 周
|
Percentage of Participants Achieving 100% Improvement in PASI Score (PASI100) at Week 16
大体时间:Week 16
|
PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination.
The severity of each sign was assessed using a 5-point scale, where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked.
The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis.
PASI100 is defined as a 100% reduction in PASI score compared with the Baseline PASI score.
The percent reduction in score is calculated as (PASI score at Baseline - score at follow-up visit) / PASI score at Baseline * 100.
NRI was used for missing data.
|
Week 16
|
Percentage of Participants Achieving an sPGA Score of Clear at Week 16
大体时间:Week 16
|
The sPGA is an assessment by the investigator of the overall disease severity at the time of evaluation.
Erythema (E), induration (I), and desquamation (D) are scored on a 5-point scale ranging from 0 (none) to 4 (severe).
The sPGA ranges from 0 to 4, and is calculated as Clear (0) = 0 for all three; Almost clear (1) = mean >0, <1.5; Mild (2) = mean ≥1.5, <2.5; Moderate (3) = mean ≥2.5, <3.5; and Severe (4) = mean ≥3.5.
NRI was used for missing data.
|
Week 16
|
Percentage of Participants Achieving a Dermatology Life Quality Index (DLQI) Score of 0 or 1 at Week 16
大体时间:Week 16
|
The DLQI is a 10-question questionnaire that asks the participant to evaluate the degree that psoriasis has affected their quality of life in the last week and includes 6 domains (symptoms and feelings, daily activities, leisure, work and school, personal relationships, and treatment).
Responses to each domain are not relevant (0), not at all (0), a little (1), a lot (2), and very much (3).
The DLQI is calculated by summing the scores of the questions and ranges from 1 to 30, where 0-1 = no effect on patient's life, 2-5 = small effect, 6-10 = moderate effect, 11-20 = very large effect, and 21-30 = extremely large effect on patient's life.
The higher the score, the more the quality of life is impaired.
NRI was used for missing data.
|
Week 16
|
Percentage of Participants Achieving an sPGA Score of Clear or Almost Clear at Week 104
大体时间:Week 104
|
The sPGA is an assessment by the investigator of the overall disease severity at the time of evaluation.
Erythema (E), induration (I), and desquamation (D) are scored on a 5-point scale ranging from 0 (none) to 4 (severe).
The sPGA ranges from 0 to 4, and is calculated as Clear (0) = 0 for all three; Almost clear (1) = mean >0, <1.5; Mild (2) = mean ≥1.5, <2.5; Moderate (3) = mean ≥2.5, <3.5; and Severe (4) = mean ≥3.5.
NRI was used for missing data.
|
Week 104
|
Percentage of Participants Achieving 75% Improvement in PASI Score (PASI75) at Week 52
大体时间:Week 52
|
PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination.
The severity of each sign was assessed using a 5-point scale, where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked.
The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis.
PASI75 is defined as at least a 75% reduction in PASI score compared with the Baseline PASI score.
The percent reduction in score is calculated as (PASI score at Baseline - score at follow-up visit) / PASI score at Baseline * 100.
NRI was used for missing data.
|
Week 52
|
Percentage of Participants Achieving 90% Improvement in PASI Score (PASI90) at Week 52
大体时间:Week 52
|
PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination.
The severity of each sign was assessed using a 5-point scale, where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked.
The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis.
PASI90 is defined as at least a 90% reduction in PASI score compared with the Baseline PASI score.
The percent reduction in score is calculated as (PASI score at Baseline - score at follow-up visit) / PASI score at Baseline * 100.
NRI was used for missing data.
|
Week 52
|
Percentage of Participants Achieving 100% Improvement in PASI Score (PASI100) at Week 52
大体时间:Week 52
|
PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination.
The severity of each sign was assessed using a 5-point scale, where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked.
The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis.
PASI100 is defined as a 100% reduction in PASI score compared with the Baseline PASI score.
The percent reduction in score is calculated as (PASI score at Baseline - score at follow-up visit) / PASI score at Baseline * 100.
NRI was used for missing data.
|
Week 52
|
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。
赞助
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
- Suleiman AA, Minocha M, Khatri A, Pang Y, Othman AA. Population Pharmacokinetics of Risankizumab in Healthy Volunteers and Subjects with Moderate to Severe Plaque Psoriasis: Integrated Analyses of Phase I-III Clinical Trials. Clin Pharmacokinet. 2019 Oct;58(10):1309-1321. doi: 10.1007/s40262-019-00759-z.
- Lebwohl MG, Soliman AM, Yang H, Wang J, Hagan K, Padilla B, Pinter A. Impact of Risankizumab on PASI90 and DLQI0/1 Duration in Moderate-to-Severe Psoriasis: A Post Hoc Analysis of Four Phase 3 Clinical Trials. Dermatol Ther (Heidelb). 2022 Feb;12(2):407-418. doi: 10.1007/s13555-021-00660-3. Epub 2021 Dec 18.
- Blauvelt A, Leonardi CL, Gooderham M, Papp KA, Philipp S, Wu JJ, Igarashi A, Flack M, Geng Z, Wu T, Camez A, Williams D, Langley RG. Efficacy and Safety of Continuous Risankizumab Therapy vs Treatment Withdrawal in Patients With Moderate to Severe Plaque Psoriasis: A Phase 3 Randomized Clinical Trial. JAMA Dermatol. 2020 Jun 1;156(6):649-658. doi: 10.1001/jamadermatol.2020.0723.
- Suleiman AA, Khatri A, Oberoi RK, Othman AA. Exposure-Response Relationships for the Efficacy and Safety of Risankizumab in Japanese Subjects with Psoriasis. Clin Pharmacokinet. 2020 May;59(5):575-589. doi: 10.1007/s40262-019-00829-2.
有用的网址
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2月29日
初级完成 (实际的)
2017年8月2日
研究完成 (实际的)
2018年7月26日
研究注册日期
首次提交
2016年2月1日
首先提交符合 QC 标准的
2016年2月1日
首次发布 (估计)
2016年2月3日
研究记录更新
最后更新发布 (实际的)
2019年10月9日
上次提交的符合 QC 标准的更新
2019年9月25日
最后验证
2019年5月1日
更多信息
与本研究相关的术语
其他研究编号
- M15-992
- 2014-005102-38 (EudraCT编号)
- 1311.4 (其他标识符:Boehringer Ingelheim)
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)?
是的
IPD 计划说明
AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor.
This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols and clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission.
This includes requests for clinical trial data for unlicensed products and indications.
IPD 共享时间框架
Data requests can be submitted at any time and the data will be accessible for 12 months, with possible extensions considered.
IPD 共享访问标准
Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous, independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Sharing Agreement (DSA).
For more information on the process, or to submit a request, visit the following link.
IPD 共享支持信息类型
- 研究协议
- 统计分析计划 (SAP)
- 临床研究报告(CSR)
- 解析代码
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.
Risankizumab的临床试验
-
AbbVie主动,不招人克罗恩病美国, 阿根廷, 澳大利亚, 奥地利, 白俄罗斯, 比利时, 波斯尼亚和黑塞哥维那, 保加利亚, 加拿大, 智利, 中国, 哥伦比亚, 克罗地亚, 捷克语, 丹麦, 埃及, 爱沙尼亚, 法国, 德国, 希腊, 香港, 爱尔兰, 以色列, 意大利, 日本, 大韩民国, 拉脱维亚, 立陶宛, 马来西亚, 墨西哥, 荷兰, 新西兰, 挪威, 波兰, 葡萄牙, 罗马尼亚, 俄罗斯联邦, 塞尔维亚, 新加坡, 斯洛伐克, 南非, 西班牙, 瑞典, 瑞士, 台湾, 乌克兰, 英国
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Jaehwan KimNational Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS); AbbVie招聘中
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AbbVie主动,不招人溃疡性结肠炎 (UC)美国, 阿根廷, 奥地利, 比利时, 巴西, 保加利亚, 加拿大, 智利, 中国, 哥伦比亚, 克罗地亚, 捷克语, 丹麦, 埃及, 法国, 德国, 希腊, 以色列, 意大利, 日本, 大韩民国, 拉脱维亚, 立陶宛, 墨西哥, 荷兰, 新西兰, 波兰, 葡萄牙, 波多黎各, 罗马尼亚, 俄罗斯联邦, 塞尔维亚, 新加坡, 斯洛伐克, 斯洛文尼亚, 南非, 西班牙, 瑞典, 瑞士, 台湾, 火鸡, 乌克兰, 英国
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AbbVie完全的化脓性汗腺炎美国, 澳大利亚, 加拿大, 法国, 德国, 日本, 荷兰, 西班牙
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AbbVieBoehringer Ingelheim完全的克罗恩病美国, 比利时, 加拿大, 德国, 大韩民国, 荷兰, 波兰, 西班牙, 英国
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AbbVie邀请报名银屑病美国, 加拿大, 德国, 日本, 波兰, 西班牙, 英国