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.
調査の概要
状態
状態
完了
条件
条件
介入・治療
介入・治療
詳細な説明
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.
研究の種類
研究の種類
介入
入学 (実際)
入学
303
段階
段階
- フェーズ 3
アクセスの拡大
アクセスの拡大
利用できない
臨床試験外。
拡張アクセス記録をご覧ください。
利用できない
- 利用可能： 現在、この治験治療には拡張アクセスが利用可能であり、臨床研究の参加者ではない患者が医薬品、生物学的製剤、または医療機器にアクセスできる可能性があります
- 利用不可： 以前はこの介入に対して拡張アクセスが利用できましたが、現在は利用できず、将来も利用できなくなります。
- 一時的に利用不可： 現在、この介入では拡張アクセスを利用できませんが、将来利用できるようになる予定です。
- マーケティング承認済み： 介入は、米国食品医薬品局によって一般使用が承認されています。
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
-
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Arkansas
-
Rogers、Arkansas、アメリカ、72758
- Northwest Arkansas Clinical Trials Center, PLLC / Hull Dermatology
-
-
California
-
Fountain Valley、California、アメリカ、92708
- Tien Q. Nguyen MD Inc
-
Los Angeles、California、アメリカ、90045
- Dermatology Research Associates
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San Luis Obispo、California、アメリカ、93405
- San Luis Dermatology and Laser Clinic
-
-
Connecticut
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Farmington、Connecticut、アメリカ、06030
- University of Connecticut
-
-
Florida
-
Coral Gables、Florida、アメリカ、33134
- Florida Academic Centers Research and Education
-
Miami、Florida、アメリカ、33144
- International Dermatology Research
-
Ocala、Florida、アメリカ、34470
- Renstar Medical Research
-
-
Georgia
-
Macon、Georgia、アメリカ、31217
- Dermatologic Surgery Specialists, P.C.
-
Newnan、Georgia、アメリカ、30263
- Medaphase Inc
-
-
Indiana
-
Plainfield、Indiana、アメリカ、46168
- The Indiana Clinical Trials Center, PC
-
-
Kentucky
-
Louisville、Kentucky、アメリカ、40202
- DS Research
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Louisville、Kentucky、アメリカ、40241
- DS Research
-
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Louisiana
-
Lake Charles、Louisiana、アメリカ、70605
- Dermatology and Advanced Aesthetics
-
-
Maryland
-
Rockville、Maryland、アメリカ、20850
- Lawrence Green, MD, LLC
-
-
Missouri
-
Saint Louis、Missouri、アメリカ、63117
- Central Dermatology
-
-
Nebraska
-
Omaha、Nebraska、アメリカ、68144
- Skin Specialists, PC
-
-
New Jersey
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East Windsor、New Jersey、アメリカ、08520
- Psoriasis Treatment Center of Central New Jersey
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-
New York
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Brooklyn、New York、アメリカ、11203
- SUNY downstate Medical Center
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Forest Hills、New York、アメリカ、11375
- Forest Hills Dermatology Group
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New York、New York、アメリカ、10029
- Icahn School of Medicine at Mount Sinai Medical Center
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New York、New York、アメリカ、10075
- Sadick Research Group
-
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North Carolina
-
Winston-Salem、North Carolina、アメリカ、27104
- Wake Forest University Health Sciences
-
-
Ohio
-
Fairborn、Ohio、アメリカ、45324
- Wright State Physicians
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Pennsylvania
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Pittsburgh、Pennsylvania、アメリカ、15213
- University of Pittsburgh Medical Center
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Texas
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Austin、Texas、アメリカ、78705
- Austin Dermatology Associates
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Dallas、Texas、アメリカ、75231
- Modern Research Associates PLLC
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Webster、Texas、アメリカ、77598
- Center for Clinical Studies
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-
Utah
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Salt Lake City、Utah、アメリカ、84107
- University of Utah
-
-
Virginia
-
Norfolk、Virginia、アメリカ、23507
- Eastern Virginia Medical School
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Norfolk、Virginia、アメリカ、23502
- Virginia Clinical Research Inc
-
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Wisconsin
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Milwaukee、Wisconsin、アメリカ、53226
- Medical College of Wisconsin
-
-
-
-
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Quebec、カナダ、G1V 4X7
- Centre de Recherche Dermatologique du Quebec Metropolitain CRDQ
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Alberta
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Calgary、Alberta、カナダ、T2G 1B1
- Kirk Barber Research
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Calgary、Alberta、カナダ、T3A 2N1
- Institute For Skin Advancement
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British Columbia
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Surrey、British Columbia、カナダ、V3R 6A7
- Chih-Ho Hong Medical, Inc.
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Surrey、British Columbia、カナダ、V3V 0C6
- Enverus Medical Research
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Manitoba
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Winnipeg、Manitoba、カナダ、R3M 3Z4
- Wiseman Dermatology Research Inc.
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Ontario
-
Markham、Ontario、カナダ、L3P1X2
- Lynderm Research
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North Bay、Ontario、カナダ、P1B 3Z7
- North Bay Dermatology Center
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Peterborough、Ontario、カナダ、K9J 5K2
- Skin Center for Dermatology
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Richmond Hill、Ontario、カナダ、L4B 1A5
- Centre for Dermatology and Cosmetic Surgery
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Toronto、Ontario、カナダ、M3H 5Y8
- The Toronto Dermatology Centre
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Waterloo、Ontario、カナダ、N2J 1C4
- K. Papp Clinical Research
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Windsor、Ontario、カナダ、N8W 1E6
- XLR8 Medical Research
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-
参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
適格基準
就学可能な年齢
18年歳以上 (大人、高齢者)
健康ボランティアの受け入れ
いいえ
受講資格のある性別
全て
説明
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.
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：4倍
アーム数
2
武器と介入
参加者グループ / アーム参加者グループ / アーム |
介入・治療介入・治療 |
|---|---|
|
実験的：Apremilast 30 mg BID
Apremilast 30 mg tablets orally twice daily (BID) during Weeks 0 to 32
|
Apremilast 30 mg tablets BID from weeks 0 to 32.
他の名前：
Placebo tablets twice daily (BID) for 16 weeks; placebo participants were switched to apremilast 30 mg at week 16.
|
|
プラセボコンパレーター：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)
|
Placebo tablets twice daily (BID) for 16 weeks; placebo participants were switched to apremilast 30 mg at week 16.
|
この研究は何を測定していますか？
主要な結果の測定
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
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
時間枠：Baseline to Week 16
|
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.
|
Baseline to Week 16
|
二次結果の測定
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Percentage of Participants With ≥ 4-Point Reduction (Improvement) From Baseline in the Whole Body Itch Numeric Rating Score at Week 16
時間枠：Baseline to Week 16
|
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.
|
Baseline to Week 16
|
|
Percentage of Participants With ≥ 4-Point Reduction (Improvement) From Baseline in the Scalp Itch Numeric Rating Score (NRS) at Week 16
時間枠：Baseline to Week 16
|
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.
|
Baseline to Week 16
|
|
Percentage of Participants With ≥ 4-Point Reduction (Improvement) From Baseline in the Whole Body Itch NRS Score by Visit in the Placebo-Controlled Phase
時間枠：Baseline to Weeks 2, 4, 6, 8 and 12
|
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.
|
Baseline to Weeks 2, 4, 6, 8 and 12
|
|
Percentage of Participants With ≥ 4-Point Reduction (Improvement) From Baseline in the Scalp Itch NRS Score by Visit in the Placebo-Controlled Phase
時間枠：Baseline to Weeks 2, 4, 8 and 12
|
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.
|
Baseline to Weeks 2, 4, 8 and 12
|
|
Change From Baseline in Dermatological Life Quality Index (DLQI) Total Score at Week 16
時間枠：Baseline to Week 16
|
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.
|
Baseline to Week 16
|
|
Number of Participants With Treatment Emergent Adverse Events (TEAE) During the Placebo-Controlled Phase
時間枠：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.
|
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.
|
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.
|
|
Number of Participants With Treatment Emergent Adverse Events During the Apremilast-Extension Phase
時間枠：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.
|
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
|
|
Number of Participants With Treatment Emergent Adverse Events During the Apremilast-Exposure Period
時間枠：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.
|
Week 0 to 32;
|
協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
出版物と役立つリンク
研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (実際)
研究開始
2017年5月16日
一次修了 (実際)
一次修了
2018年8月13日
研究の完了 (実際)
研究の完了
2019年1月9日
試験登録日
最初に提出
最初に提出
2017年4月18日
QC基準を満たした最初の提出物
QC基準を満たした最初の提出物
2017年4月18日
最初の投稿 (実際)
最初の投稿
2017年4月21日
学習記録の更新
投稿された最後の更新 (実際)
投稿された最後の更新
2020年5月13日
QC基準を満たした最後の更新が送信されました
QC基準を満たした最後の更新が送信されました
2020年4月28日
最終確認日
最終確認日
2020年4月1日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
その他の研究ID番号
- CC-10004-SPSO-001
- U1111-1194-1248 (レジストリ識別子：WHO)
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
はい
IPD プランの説明
De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request
IPD 共有時間枠
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 共有アクセス基準
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 共有サポート情報タイプ
- 研究プロトコル
- 統計分析計画 (SAP)
- インフォームド コンセント フォーム (ICF)
- 臨床試験報告書（CSR）
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
はい
米国FDA規制機器製品の研究
いいえ
米国で製造され、米国から輸出された製品。
いいえ
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。