A Study of Baricitinib (LY3009104) in Participants With Moderate-to-Severe Atopic Dermatitis
2020年6月10日 更新者：Eli Lilly and Company
A Randomized, Double-Blind, Placebo-Controlled, Phase 2 Study to Evaluate the Safety and Efficacy of Baricitinib in Patients With Moderate-to-Severe Atopic Dermatitis
The purpose of this study is to evaluate the safety and effectiveness of Baricitinib in eczema.
調査の概要
研究の種類
介入
入学 (実際)
124
段階
- フェーズ2
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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California
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Los Angeles、California、アメリカ、90045
- Dermatology Research Associates
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Florida
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Tampa、Florida、アメリカ、33624
- Forward Clinical Trials, Inc
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Georgia
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Atlanta、Georgia、アメリカ、30342
- Medical Dermatology Specialists
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Illinois
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Chicago、Illinois、アメリカ、60611
- Northwestern University
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New York
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New York、New York、アメリカ、10029
- Icahn School of Medicine
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Oregon
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Portland、Oregon、アメリカ、97239
- Oregon Health and Science University
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Texas
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Dallas、Texas、アメリカ、75246
- Menter Dermatology Research Institute
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Houston、Texas、アメリカ、77004
- Center for Clinical Studies
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Houston、Texas、アメリカ、77065
- Center for Clinical Studies
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Webster、Texas、アメリカ、77598
- Center for Clinical Studies
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Fukuoka-shi、日本、815-0082
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Sapporo、日本、060-0063
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Takaoka-shi、日本、933-0871
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician
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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
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:
Have moderate-to-severe Atopic Dermatitis (AD), as determined by all of the following:
- EASI of 12 or more
- Greater than or equal to 10% of body surface area involvement
- Diagnosed with AD at least 2 years prior
- Have a history of inadequate clinical response to other eczema treatments
Exclusion Criteria:
- Females who are pregnant or nursing
- Participants who do not agree to use adequate contraception
Are currently experiencing or have a history of:
- Skin conditions such as psoriasis or lupus erythematosus
- Skin disease that requires frequent hospitalizations or intravenous treatment
- Compromised immunity
- Serious illness that could interfere with study participation, or a clinically important deviation in physical examination, vital sign measurements, electrocardiograms, or abnormalities on laboratory tests
Currently experiencing or have a history of:
- Active or latent Tuberculosis or specific immunity disorders and infections
- Malignancy or lymphoproliferative diseases in the last 5 years (or cervical, basal or squamous skin cancer re-occurrence in the last 3 years)
- Human Immunodeficiency Virus (HIV)
- Hepatitis B, Hepatitis C, or chronic liver disease
- Have received certain types of vaccinations
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：ダブル
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的：Baricitinib
Administered once daily in multiple oral dose cohorts for 16 weeks (Triamcinolone 0.1% topical also permitted) |
経口投与
他の名前：
Administered topically
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プラセボコンパレーター：Placebo
Administered orally once daily, for 16 weeks (Triamcinolone 0.1% topical also permitted) |
経口投与
Administered topically
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Percentage of Participants With a 50% or Greater Reduction in the Eczema Area and Severity Index (EASI 50)
時間枠：Week 16
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The EASI 50, defined as ≥ 50% reduction from baseline in EASI score, assesses extent of disease based on dividing the skin into 4 regions (head/neck, trunk, upper limbs, and lower limbs) and measures the following clinical signs: (1) erythema, (2) edema/papulation, (3) excoriation, and (4) lichenification each on a scale of 0 to 3.The EASI confers a maximum score of 72 with 0 = clear; 0.1 -1 = almost clear; 1.1 -7 = mild; 7.1 - 21 = moderate; 21.1 - 50 = severe; 50.1 - 72 = very severe.
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Week 16
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Change From Baseline in the EASI at Week 16
時間枠：Baseline, Week 16
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The Eczema Area and Severity Index (EASI) assesses extent of disease based on dividing the skin into 4 regions (head/neck, trunk, upper limbs, and lower limbs) and measures the following clinical signs: (1) erythema, (2) edema/papulation, (3) excoriation, and (4) lichenification each on a scale of 0 to 3.The EASI confers a maximum score of 72 with 0 = clear; 0.1 -1 = almost clear; 1.1 -7 = mild; 7.1 - 21 = moderate; 21.1 - 50 = severe; 50.1 - 72 = very severe.
Change from baseline were analyzed with a Mixed-effect Model Repeated Measure (MMRM) with fixed effects for treatment, visit, country, and the treatment-by-visit interaction, plus baseline and baseline-by-visit included as covariates.
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Baseline, Week 16
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Percentage Change From Baseline in the EASI at Week 16
時間枠：Baseline, Week 16
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The Eczema Area and Severity Index (EASI) assesses extent of disease based on dividing the skin into 4 regions (head/neck, trunk, upper limbs, and lower limbs) and measures the following clinical signs: (1) erythema, (2) edema/papulation, (3) excoriation, and (4) lichenification each on a scale of 0 to 3.The EASI confers a maximum score of 72 with 0 = clear; 0.1 -1 = almost clear; 1.1 -7 = mild; 7.1 - 21 = moderate; 21.1 - 50 = severe; 50.1 - 72 = very severe.
Changes from baseline were analyzed with an MMRM with fixed effects for treatment, visit, country, and the treatment-by-visit interaction, plus baseline and baseline-by-visit included as covariates.
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Baseline, Week 16
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Change From Baseline in the Scoring Atopic Dermatitis (SCORAD) at Week 16
時間枠：Baseline, Week 16
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The SCORAD index uses the rule of nines to assess disease extent and evaluates five clinical characteristics to determine disease severity: (1) erythema, (2) edema/papulation, (3) oozing/crusts, (4) excoriation and (5) lichenification.
SCORAD also assesses subjective symptoms of pruritus and sleep loss with Visual Analogue Scales (VAS) where 0 is no itch (or sleeplessness) and 10 is the worst imaginable itch (or sleeplessness).
These three aspects: extent of disease (A: 0-102), disease severity (B: 0-18) and subjective symptoms (C:0-20) combine using A/5 + 7*B/2+ C to give a maximum possible score of 103 where 0 = no disease and 103 = severe disease.
Changes from baseline were analyzed with an MMRM with fixed effects for treatment, visit, country, and the treatment-by-visit interaction, plus baseline and baseline-by-visit included as covariates.
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Baseline, Week 16
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Change From Baseline in the Investigator's Global Assessment (IGA) at Week 16
時間枠：Baseline, Week 16
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The IGA consists of a 6-point severity scale to measure characteristics of erythema, infiltration, papulation, oozing and crusting as guidelines for the overall severity assessment.
The scale ranges from clear to very severe disease (0 = clear, 1 = almost clear, 2 = mild disease, 3 = moderate disease, 4 = severe disease and 5 = very severe disease).
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Baseline, Week 16
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Change From Baseline in the Dermatologic Life Quality Index (DLQI) at Week 16
時間枠：Baseline, Week 16
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The DLQI is a simple, participant-administered, 10-question, validated, quality-of-life questionnaire that covers 6 domains including symptoms and feelings, daily activities, leisure, work and school, personal relationships, and treatment.
Response categories include "Not at all," "A little," "A lot," and "Very much," with corresponding scores of 0, 1, 2, and 3 respectively.
Questions 3-10 also have an additional response category of "Not relevant" which is scored as "0".
For all questions, if unanswered the question is scored as "0".
Totals range from 0 to 30 (less to more impairment).
Changes from baseline in DLQI score were analyzed with an MMRM with fixed effects for treatment, time, country, and the treatment-by-visit interaction, plus baseline and baseline-by-visit were included as covariates.
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Baseline, Week 16
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Change From Baseline in the Itch Numerical Rating Scale (NRS) at Week 16
時間枠：Baseline, Week 16
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The Itch NRS is a participant-administered, 11-point horizontal scale anchored at 0 and 10, with 0 representing "no itch" and 10 representing "worst itch imaginable."
Overall severity of a participant's itching is indicated by circling the number that best describes the worst level of itching in the past 24 hours.
Changes from baseline were analyzed with an MMRM with fixed effects for treatment, time, country, and the treatment-by-visit interaction, plus baseline and baseline-by-visit were included as covariates.
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Baseline, Week 16
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Pharmacokinetics (PK): Maximum Serum Concentration (Cmax) of Baricitinib
時間枠：Week (Wk) 0: Predose, 15-30 minutes (min) postdose; Wk 4: 1.5 - 4 hour (hr) postdose; Wk 8: 4 - 8 hr postdose; Wk 12: Predose; Wk 16: 30 - 90 min postdose.
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Pharmacokinetics (PK): Maximum serum concentration (Cmax) of Baricitinib
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Week (Wk) 0: Predose, 15-30 minutes (min) postdose; Wk 4: 1.5 - 4 hour (hr) postdose; Wk 8: 4 - 8 hr postdose; Wk 12: Predose; Wk 16: 30 - 90 min postdose.
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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。
スポンサー
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。
一般刊行物
- King B, Maari C, Lain E, Silverberg JI, Issa M, Holzwarth K, Brinker D, Cardillo T, Nunes FP, Simpson EL. Extended Safety Analysis of Baricitinib 2 mg in Adult Patients with Atopic Dermatitis: An Integrated Analysis from Eight Randomized Clinical Trials. Am J Clin Dermatol. 2021 May;22(3):395-405. doi: 10.1007/s40257-021-00602-x. Epub 2021 Apr 7.
- Katoh N, Takita Y, Isaka Y, Nishikawa A, Torisu-Itakura H, Saeki H. Pooled Safety Analysis of Baricitinib in Adult Participants with Atopic Dermatitis in the Japanese Subpopulation from Six Randomized Clinical Trials. Dermatol Ther (Heidelb). 2022 Dec;12(12):2765-2779. doi: 10.1007/s13555-022-00828-5. Epub 2022 Oct 18.
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
2016年2月1日
一次修了 (実際)
2017年2月1日
研究の完了 (実際)
2017年3月1日
試験登録日
最初に提出
2015年10月14日
QC基準を満たした最初の提出物
2015年10月14日
最初の投稿 (見積もり)
2015年10月15日
学習記録の更新
投稿された最後の更新 (実際)
2020年6月17日
QC基準を満たした最後の更新が送信されました
2020年6月10日
最終確認日
2020年6月1日
詳しくは
本研究に関する用語
キーワード
追加の関連 MeSH 用語
その他の研究ID番号
- 16284
- I4V-MC-JAHG (その他の識別子：Eli Lilly and Company)
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
Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.
IPD 共有時間枠
Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later.
Data will be indefinitely available for requesting
IPD 共有アクセス基準
A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
IPD 共有サポート情報タイプ
- STUDY_PROTOCOL
- SAP
- CSR
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。