A Study of the Efficacy and Safety of Apremilast (CC-10004) in Subjects With Moderate to Severe Plaque Psoriasis of the Scalp (STYLE)
2020年4月28日 更新者：Amgen
A Phase 3, Multi-Center, Randomized, Placebo-Controlled, Double-Blind, Study of the Efficacy and Safety of Apremilast (CC-10004) in Subjects With Moderate to Severe Plaque Psoriasis of the Scalp
This is a Phase 3, multicenter, randomized, placebo-controlled, double-blind study of the efficacy and safety of apremilast (CC-10004) in subjects with moderate to severe plaque psoriasis of the scalp.
Approximately 300 subjects with moderate to severe plaque psoriasis of the scalp will be randomized 2:1 to receive either apremilast 30 mg twice daily (BID) or placebo for the first 16 weeks.
研究概览
详细说明
The study will consist of four phases:
- Screening Phase - up to 35 days
Double-blind Placebo-controlled Phase- Weeks 0 to 16 Subjects will receive treatment with one of the following:
- apremilast 30 mg tablets orally BID or
- placebo tablets (identical in appearance to apremilast 30 mg tablets) orally BID
Apremilast Extension Phase - Weeks 16 to 32
- All subjects who had received placebo during the placebo-controlled phase will be switched to apremilast 30 mg BID (or continue with) apremilast. At Week 16, all subjects will maintain this dosing through Week 32.
Observational Follow-up Phase
- Four-week Post-Treatment Observational Follow-up Phase for all subjects who complete the study or discontinue from the study early.
研究类型
介入性
注册 (实际的)
303
阶段
- 第三阶段
扩展访问
不再可用
查看扩展访问记录。
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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Quebec、加拿大、G1V 4X7
- Centre de Recherche Dermatologique du Quebec Metropolitain CRDQ
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Alberta
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Calgary、Alberta、加拿大、T2G 1B1
- Kirk Barber Research
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Calgary、Alberta、加拿大、T3A 2N1
- Institute For Skin Advancement
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British Columbia
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Surrey、British Columbia、加拿大、V3R 6A7
- Chih-Ho Hong Medical, Inc.
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Surrey、British Columbia、加拿大、V3V 0C6
- Enverus Medical Research
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Manitoba
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Winnipeg、Manitoba、加拿大、R3M 3Z4
- Wiseman Dermatology Research Inc.
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Ontario
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Markham、Ontario、加拿大、L3P1X2
- Lynderm Research
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North Bay、Ontario、加拿大、P1B 3Z7
- North Bay Dermatology Center
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Peterborough、Ontario、加拿大、K9J 5K2
- Skin Center for Dermatology
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Richmond Hill、Ontario、加拿大、L4B 1A5
- Centre for Dermatology and Cosmetic Surgery
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Toronto、Ontario、加拿大、M3H 5Y8
- The Toronto Dermatology Centre
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Waterloo、Ontario、加拿大、N2J 1C4
- K. Papp Clinical Research
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Windsor、Ontario、加拿大、N8W 1E6
- XLR8 Medical Research
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Arkansas
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Rogers、Arkansas、美国、72758
- Northwest Arkansas Clinical Trials Center, PLLC / Hull Dermatology
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California
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Fountain Valley、California、美国、92708
- Tien Q. Nguyen MD Inc
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Los Angeles、California、美国、90045
- Dermatology Research Associates
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San Luis Obispo、California、美国、93405
- San Luis Dermatology and Laser Clinic
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Connecticut
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Farmington、Connecticut、美国、06030
- University of Connecticut
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Florida
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Coral Gables、Florida、美国、33134
- Florida Academic Centers Research and Education
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Miami、Florida、美国、33144
- International Dermatology Research
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Ocala、Florida、美国、34470
- Renstar Medical Research
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Georgia
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Macon、Georgia、美国、31217
- Dermatologic Surgery Specialists, P.C.
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Newnan、Georgia、美国、30263
- Medaphase Inc
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Indiana
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Plainfield、Indiana、美国、46168
- The Indiana Clinical Trials Center, PC
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Kentucky
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Louisville、Kentucky、美国、40202
- DS Research
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Louisville、Kentucky、美国、40241
- DS Research
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Louisiana
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Lake Charles、Louisiana、美国、70605
- Dermatology and Advanced Aesthetics
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Maryland
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Rockville、Maryland、美国、20850
- Lawrence Green, MD, LLC
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Missouri
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Saint Louis、Missouri、美国、63117
- Central Dermatology
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Nebraska
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Omaha、Nebraska、美国、68144
- Skin Specialists, PC
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New Jersey
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East Windsor、New Jersey、美国、08520
- Psoriasis Treatment Center of Central New Jersey
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New York
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Brooklyn、New York、美国、11203
- SUNY downstate Medical Center
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Forest Hills、New York、美国、11375
- Forest Hills Dermatology Group
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New York、New York、美国、10029
- Icahn School of Medicine at Mount Sinai Medical Center
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New York、New York、美国、10075
- Sadick Research Group
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North Carolina
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Winston-Salem、North Carolina、美国、27104
- Wake Forest University Health Sciences
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Ohio
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Fairborn、Ohio、美国、45324
- Wright State Physicians
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Pennsylvania
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Pittsburgh、Pennsylvania、美国、15213
- University of Pittsburgh Medical Center
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Texas
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Austin、Texas、美国、78705
- Austin Dermatology Associates
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Dallas、Texas、美国、75231
- Modern Research Associates PLLC
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Webster、Texas、美国、77598
- Center for Clinical Studies
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Utah
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Salt Lake City、Utah、美国、84107
- University of Utah
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Virginia
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Norfolk、Virginia、美国、23507
- Eastern Virginia Medical School
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Norfolk、Virginia、美国、23502
- Virginia Clinical Research Inc
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Wisconsin
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Milwaukee、Wisconsin、美国、53226
- Medical College of Wisconsin
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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:
Subjects must satisfy the following criteria to be enrolled in the study:
- Males or females, ≥ 18 years of age at the time of signing the informed consent document
- Be willing and able to adhere to the study visit schedule and other protocol requirements.
- Have a diagnosis of moderate to severe plaque psoriasis of the scalp at screening and baseline
- Must be a candidate for phototherapy and/or systemic therapy for either body or scalp psoriasis lesions.
- Have moderate to severe plaque psoriasis at screening and baseline
- Must be in good health (except for psoriasis) as judged by the Investigator, based on medical history, physical examination, 12-lead electrocardiogram (ECG), clinical laboratories, and urinalysis
- Must meet laboratory criteria
- Females of childbearing potential (FCBP)* must have a negative pregnancy test at screening and baseline. While on investigational product (IP) and for at least 28 days after taking the last dose of investigational product, FCBP who engage in activity in which conception is possible - must use one of the approved contraceptive** options described below:
Option 1: Any one of the following highly effective methods: hormonal contraception (oral, injection, implant, transdermal patch, vaginal ring); intrauterine device (IUD); tubal ligation; or partner's vasectomy; OR Option 2: Male or female condom (latex condom or nonlatex condom NOT made out of natural [animal] membrane [for example, polyurethane]; PLUS one additional barrier method: (a) diaphragm with spermicide; (b) cervical cap with spermicide; or (c) contraceptive sponge with spermicide.
*A female of childbearing potential is a sexually mature female who 1) has not undergone a hysterectomy (the surgical removal of the uterus) or bilateral oophorectomy (the surgical removal of both ovaries) or 2) has not been postmenopausal for at least 24 consecutive months (that is, has had menses at any time during the preceding 24 consecutive months).
** The female subject's chosen form of contraception must be effective by the time the female subject is randomized into the study (for example, hormonal contraception should be initiated at least 28 days before randomization).
Exclusion Criteria:
The presence of any of the following will exclude a subject from enrollment:
- Other than psoriasis, history of any clinically significant uncontrolled disease.
Any condition, including the presence of laboratory abnormalities, which would place the subject at unacceptable risk if he/she were to participate in the study.
- Pregnant or breast feeding
- Hepatitis B surface antigen positive at screening
- Anti-hepatitis C antibody positive at screening
- Active tuberculosis (TB) or a history of incompletely treated TB
- Clinically significant abnormality on 12-lead electrocardiogram (ECG) at screening
- History of positive human immunodeficiency virus (HIV), or have congenital or acquired immunodeficiency (eg, common variable immunodeficiency disease)
- Active substance abuse or a history of substance abuse within 6 months prior to signing the informed consent form.
- Bacterial infections requiring treatment with oral or injectable antibiotics, or significant viral or fungal infections, within 4 weeks of signing the informed consent form.
- Malignancy or history of malignancy, except for treated (i.e., cured) basal cell or squamous cell in situ skin carcinomas or treated (i.e., cured) cervical intraepithelial neoplasia (CIN) or carcinoma in situ of the cervix with no evidence of recurrence within 5 years of signing the informed consent.
- Prior history of suicide attempt at any time in the subject's life time prior to signing the informed consent and randomization, or major psychiatric illness requiring hospitalization within the last 3 years prior to signing the informed consent.
- Psoriasis flare/rebound within 4 weeks of signing the informed consent form or between the screening and baseline visits.
- Topical therapy within 2 weeks prior to randomization; Conventional systemic therapy for psoriasis within 4 weeks prior to randomization; Intralesional corticosteroids on the scalp within 2 weeks prior to randomization; Phototherapy treatment of body or scalp psoriasi lesions within 4 weeks prior to randomization; Biologic therapy between 12 weeks to 24 weeks prior to randomization
- Use of any investigational drug beginning 4 weeks prior to randomization, or 5 pharmacokinetic/pharmacodynamic half-lives, if known (whichever is longer)
- Prolonged sun exposure or use of tanning booths or other ultraviolet (UV) light sources
- Prior treatment with apremilast
- History of allergy or hypersensitivity to any components of the Investigational 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：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 |
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实验性的：Apremilast 30 mg BID
Apremilast 30 mg tablets orally twice daily (BID) during Weeks 0 to 32
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Apremilast 30 mg tablets BID from weeks 0 to 32.
其他名称：
Placebo tablets twice daily (BID) for 16 weeks; placebo participants were switched to apremilast 30 mg at week 16.
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安慰剂比较：Placebo
Placebo tablets BID during weeks 0 to 16; at week 16, placebo participants were switched to apremilast 30 mg tablets BID for 16 weeks (from Week 16 to Week 32)
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Placebo tablets twice daily (BID) for 16 weeks; placebo participants were switched to apremilast 30 mg at week 16.
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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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Percentage of Participants With Scalp Physician Global Assessment (ScPGA) Score of Clear (0) or Almost Clear (1) With at Least a 2-Point Reduction From Baseline
大体时间：Baseline to Week 16
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The ScPGA is a measurement of overall scalp involvement by the investigator at the time of evaluation.
The ScPGA is a 5-point scale ranging from 0 (clear) to 4 (severe), incorporating an assessment of the severity of the 3 primary signs of the disease: erythema, scaling, and plaque elevation.
When making the assessment of overall scalp severity, the investigator factored in areas that had already been cleared (ie, had scores of 0), not limited to the evaluation of remaining lesions for severity; consequently, the severity of each sign was averaged across all areas of involvement, including cleared lesions.
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Baseline to Week 16
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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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Percentage of Participants With ≥ 4-Point Reduction (Improvement) From Baseline in the Whole Body Itch Numeric Rating Score at Week 16
大体时间：Baseline to Week 16
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The Whole Body Itch NRS scale is an 11-point scale to assess whole body itch.
The scale ranges from 0-10, where "0" represents no itch, and "10" represents the worst imaginable itch, and a 4-point change from baseline was shown to be optimal for demonstrating a level of clinically meaningful improvement in itch severity.
NRS response was defined as a ≥ 4-point reduction (improvement) from baseline.
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Baseline to Week 16
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Percentage of Participants With ≥ 4-Point Reduction (Improvement) From Baseline in the Scalp Itch Numeric Rating Score (NRS) at Week 16
大体时间：Baseline to Week 16
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The scalp itch NRS is a 11-point scale to assess scalp itch.
The scale ranges from 0-10, where "0" represents no itch, and "10" represents the worst imaginable itch.
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Baseline to Week 16
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Percentage of Participants With ≥ 4-Point Reduction (Improvement) From Baseline in the Whole Body Itch NRS Score by Visit in the Placebo-Controlled Phase
大体时间：Baseline to Weeks 2, 4, 6, 8 and 12
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The Whole Body Itch NRS scale is a 11-point scale to assess whole body itch.
The scale ranges from 0-10, where "0" represents no itch, and "10" represents the worst imaginable itch, and a 4-point change from baseline was shown to be optimal for demonstrating a level of clinically meaningful improvement in itch severity.
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Baseline to Weeks 2, 4, 6, 8 and 12
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Percentage of Participants With ≥ 4-Point Reduction (Improvement) From Baseline in the Scalp Itch NRS Score by Visit in the Placebo-Controlled Phase
大体时间：Baseline to Weeks 2, 4, 8 and 12
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The scalp itch NRS is a 11-point scale to assess scalp itch.
The scale ranges from 0-10, where "0" represents no itch, and "10" represents the worst imaginable itch.
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Baseline to Weeks 2, 4, 8 and 12
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Change From Baseline in Dermatological Life Quality Index (DLQI) Total Score at Week 16
大体时间：Baseline to Week 16
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DLQI is questionnaire for use in a dermatology clinical setting to assess limitations related to the impact of skin disease.
The instrument contains ten items dealing with the participant's skin.
With the exception of Item Number 7, the participant responds on a four-point scale, ranging from "Very Much" (score 3) to "Not at All" or "Not relevant" (score 0).
Item Number 7 is a multi-part item, the first part of which ascertains whether the participant's skin prevented them from working or studying (Yes or No, scores 3 or 0 respectively), and if "No," then the subject is asked how much of a problem the skin has been at work or study over the past week, with response alternatives being "A lot," "A little," or "Not at all" (scores 2, 1, or 0 respectively).
The DLQI total score was derived by summing all item scores, and has a possible range of 0 to 30, with 30 corresponding to the worst quality of life, and 0 corresponding to the best.
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Baseline to Week 16
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Number of Participants With Treatment Emergent Adverse Events (TEAE) During the Placebo-Controlled Phase
大体时间：Week 0 to Week 16; mean duration of exposure was 14.5 weeks and 14.6 weeks for participants randomized to placebo and apremilast respectively.
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A TEAE is an AE with a start date on or after the date of the first dose of study drug and no later than 28 days after the last dose of study drug.
A serious AE (SAE) is any untoward AE that is fatal, life-threatening, results in persistent or significant disability or incapacity, requires or prolongs existing in-patient hospitalization, is a congenital anomaly/birth defect, or is a condition that may jeopardize or may require intervention to prevent one of the outcomes above.
The severity of AEs was assessed based on the following scale: Mild = asymptomatic or mild symptoms, clinical or diagnostic observations only; Moderate = symptoms cause moderate discomfort; Severe = could be non-serious or serious) = symptoms causing severe pain discomfort.
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Week 0 to Week 16; mean duration of exposure was 14.5 weeks and 14.6 weeks for participants randomized to placebo and apremilast respectively.
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Number of Participants With Treatment Emergent Adverse Events During the Apremilast-Extension Phase
大体时间：Weeks 16 to Week 32; the mean treatment duration was 14.6 weeks and 15.3 weeks in the APR 30/APR 30 BID and placebo/APR 30 BID arms, respectively
|
A TEAE is an AE with a start date on or after the date of the first dose of study drug and no later than 28 days after the last dose of study drug.
A serious AE (SAE) is any untoward AE that is fatal, life-threatening, results in persistent or significant disability or incapacity, requires or prolongs existing in-patient hospitalization, is a congenital anomaly/birth defect, or is a condition that may jeopardize or may require intervention to prevent one of the outcomes above.
The severity of AEs was assessed based on the following scale: Mild = asymptomatic or mild symptoms, clinical or diagnostic observations only; Moderate = symptoms cause moderate discomfort; Severe = could be non-serious or serious) = symptoms causing severe pain discomfort.
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Weeks 16 to Week 32; the mean treatment duration was 14.6 weeks and 15.3 weeks in the APR 30/APR 30 BID and placebo/APR 30 BID arms, respectively
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Number of Participants With Treatment Emergent Adverse Events During the Apremilast-Exposure Period
大体时间：Week 0 to 32;
|
The apremilast-exposure period started on the date of the first dose of apremilast (Week 0 for participants originally randomized to apremilast or Week 16 for participants originally randomized to placebo) to the last dose of apremilast.
A TEAE is an AE with a start date on or after the date of the first dose of study drug and no later than 28 days after the last dose of study drug.
A serious AE (SAE) is any untoward AE that is fatal, life-threatening, results in persistent or significant disability or incapacity, requires or prolongs existing in-patient hospitalization, is a congenital anomaly/birth defect, or is a condition that may jeopardize or may require intervention to prevent one of the outcomes above.
The severity of AEs was assessed based on the following scale: Mild = asymptomatic or mild symptoms, clinical or diagnostic observations only; Moderate = symptoms cause moderate discomfort; Severe = could be non-serious or serious) = symptoms causing severe pain discomfort.
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Week 0 to 32;
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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。
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。
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)
2017年5月16日
初级完成 (实际的)
2018年8月13日
研究完成 (实际的)
2019年1月9日
研究注册日期
首次提交
2017年4月18日
首先提交符合 QC 标准的
2017年4月18日
首次发布 (实际的)
2017年4月21日
研究记录更新
最后更新发布 (实际的)
2020年5月13日
上次提交的符合 QC 标准的更新
2020年4月28日
最后验证
2020年4月1日
更多信息
与本研究相关的术语
其他相关的 MeSH 术语
其他研究编号
- CC-10004-SPSO-001
- U1111-1194-1248 (注册表标识符：WHO)
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
De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request
IPD 共享时间框架
Data sharing requests relating to this study will be considered beginning 18 months after the study has ended and either 1) the product and indication have been granted marketing authorization in both the US and Europe or 2) clinical development for the product and/or indication discontinues and the data will not be submitted to regulatory authorities.
There is no end date for eligibility to submit a data sharing request for this study.
IPD 共享访问标准
Qualified researchers may submit a request containing the research objectives, the Amgen product(s) and Amgen study/studies in scope, endpoints/outcomes of interest, statistical analysis plan, data requirements, publication plan, and qualifications of the researcher(s).
In general, Amgen does not grant external requests for individual patient data for the purpose of re-evaluating safety and efficacy issues already addressed in the product labelling.
Requests are reviewed by a committee of internal advisors.
If not approved, a Data Sharing Independent Review Panel will arbitrate and make the final decision.
Upon approval, information necessary to address the research question will be provided under the terms of a data sharing agreement.
This may include anonymized individual patient data and/or available supporting documents, containing fragments of analysis code where provided in analysis specifications.
Further details are available at the URL below.
IPD 共享支持信息类型
- 研究协议
- 统计分析计划 (SAP)
- 知情同意书 (ICF)
- 临床研究报告（CSR）
药物和器械信息、研究文件
研究美国 FDA 监管的药品
是的
研究美国 FDA 监管的设备产品
不
在美国制造并从美国出口的产品
不
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.
Apremilast的临床试验
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National and Kapodistrian University of AthensAndreas Syggros Hospital of Venereal and Dermatological Diseases完全的
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Amgen招聘中活动性幼年型银屑病关节炎西班牙, 法国, 希腊, 意大利, 英国, 奥地利, 德国, 荷兰, 立陶宛, 罗马尼亚, 南非, 葡萄牙, 比利时, 土耳其（türkiye）, 波兰
-
Takeda完全的
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Yale UniversityNational Institute on Alcohol Abuse and Alcoholism (NIAAA)招聘中