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Study to Assess the Efficacy and Long-term Safety of Dupilumab (REGN668/SAR231893) in Adult Participants With Moderate-to-Severe Atopic Dermatitis (CHRONOS)

2017年10月12日 更新者：Regeneron Pharmaceuticals

A Randomized, Double-Blind, Placebo-Controlled Study to Demonstrate the Efficacy and Long-Term Safety of Dupilumab in Adult Patients With Moderate-to-Severe Atopic Dermatitis

The primary objective of the study was to demonstrate the efficacy of Dupilumab administered concomitantly with topical corticosteroid (TCS) through Week 16 in adult participants with moderate-to-severe atopic dermatitis (AD) compared to placebo administered concomitantly with TCS.

調査の概要

状態

完了

条件

介入・治療

研究の種類

介入

入学 (実際)

740

段階

  • フェーズ 3

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

  • アメリカ
    • Arizona
      • Phoenix、Arizona、アメリカ
    • Arkansas
      • Hot Springs、Arkansas、アメリカ
      • Little Rock、Arkansas、アメリカ
    • California
      • Encinitas、California、アメリカ
      • Oceanside、California、アメリカ
      • Palmdale、California、アメリカ
      • San Diego、California、アメリカ
    • Connecticut
      • New Haven、Connecticut、アメリカ
      • Trumbull、Connecticut、アメリカ
    • Florida
      • Edgewater、Florida、アメリカ
      • Lake Worth、Florida、アメリカ
      • Miami Lakes、Florida、アメリカ
      • Orlando、Florida、アメリカ
      • Tampa、Florida、アメリカ
    • Georgia
      • Alpharetta、Georgia、アメリカ
      • Columbus、Georgia、アメリカ
      • Savannah、Georgia、アメリカ
    • Illinois
      • West Dundee、Illinois、アメリカ
    • Indiana
      • Carmel、Indiana、アメリカ
      • New Albany、Indiana、アメリカ
    • Maryland
      • Rockville、Maryland、アメリカ
    • Michigan
      • Ann Arbor、Michigan、アメリカ
      • Bay City、Michigan、アメリカ
    • Minnesota
      • Edina、Minnesota、アメリカ
      • Fridley、Minnesota、アメリカ
    • Missouri
      • Saint Louis、Missouri、アメリカ
    • Nebraska
      • Omaha、Nebraska、アメリカ
    • Nevada
      • Henderson、Nevada、アメリカ
    • New Jersey
      • Verona、New Jersey、アメリカ
    • New Mexico
      • Albuquerque、New Mexico、アメリカ
    • New York
      • Corning、New York、アメリカ
      • New York、New York、アメリカ
      • Smithtown、New York、アメリカ
      • Stony Brook、New York、アメリカ
    • Ohio
      • Cincinnati、Ohio、アメリカ
    • Oklahoma
      • Norman、Oklahoma、アメリカ
      • Oklahoma City、Oklahoma、アメリカ
    • Oregon
      • Lake Oswego、Oregon、アメリカ
      • Portland、Oregon、アメリカ
    • Pennsylvania
      • Exton、Pennsylvania、アメリカ
      • Hazleton、Pennsylvania、アメリカ
      • Philadelphia、Pennsylvania、アメリカ
    • Texas
      • Austin、Texas、アメリカ
      • Dallas、Texas、アメリカ
    • Utah
      • West Jordan、Utah、アメリカ
    • Vermont
      • South Burlington、Vermont、アメリカ
    • Virginia
      • Henrico、Virginia、アメリカ
      • Norfolk、Virginia、アメリカ
      • Richmond、Virginia、アメリカ
    • Washington
      • Spokane、Washington、アメリカ
  • イギリス
      • Liverpool、イギリス
      • Manchester、イギリス
      • Reading、イギリス
      • Salford、イギリス
    • Angus
      • Dundee、Angus、イギリス
    • Birmingham
      • Edgbaston、Birmingham、イギリス
    • Glasgow City
      • Glasgow、Glasgow City、イギリス
    • Kent
      • Sidcup、Kent、イギリス
    • Middlesex
      • Northwood、Middlesex、イギリス
  • イタリア
      • Ancona、イタリア
      • Bologna、イタリア
      • Brescia、イタリア
      • Novara、イタリア
      • Pavia、イタリア
      • Perugia、イタリア
      • Roma、イタリア
  • オランダ
      • Groningen、オランダ
      • Utrecht、オランダ
    • Noord-Brabant
      • Breda、Noord-Brabant、オランダ
    • Noord-Holland
      • Amsterdam、Noord-Holland、オランダ
    • Zuid-Holland
      • Rotterdam、Zuid-Holland、オランダ
  • オーストラリア
    • Australian Capital Territory
      • Phillip、Australian Capital Territory、オーストラリア
    • New South Wales
      • Kogarah、New South Wales、オーストラリア
    • Queensland
      • Benowa、Queensland、オーストラリア
      • Dulwich、Queensland、オーストラリア
    • South Australia
      • Hectorville、South Australia、オーストラリア
    • Victoria
      • Carlton、Victoria、オーストラリア
  • カナダ
      • Quebec、カナダ
    • British Columbia
      • Surrey、British Columbia、カナダ
      • Vancouver、British Columbia、カナダ
    • Ontario
      • Ajax、Ontario、カナダ
      • Barrie、Ontario、カナダ
      • Hamilton、Ontario、カナダ
      • Markham、Ontario、カナダ
      • North Bay、Ontario、カナダ
      • Oakville、Ontario、カナダ
      • Ottawa、Ontario、カナダ
      • Peterborough、Ontario、カナダ
      • Richmond Hill、Ontario、カナダ
      • Toronto、Ontario、カナダ
      • Waterloo、Ontario、カナダ
      • Windsor、Ontario、カナダ
    • Quebec
      • Drummondville、Quebec、カナダ
  • スペイン
      • Alicante、スペイン
      • Madrid、スペイン
    • Cataluña
      • Barcelona、Cataluña、スペイン
  • チェコ
      • Hradec Kralove、チェコ
      • Nachod、チェコ
      • Praha 10、チェコ
      • Praha 5、チェコ
      • Svitavy、チェコ
      • Usti nad Labem、チェコ
  • ニュージーランド
      • Auckland、ニュージーランド
    • South Island
      • Dunedin、South Island、ニュージーランド
  • ハンガリー
      • Budapest、ハンガリー
    • Békés
      • Oroshaza、Békés、ハンガリー
    • Jász-Nagykun-Szolnok
      • Szolnok、Jász-Nagykun-Szolnok、ハンガリー
    • Veszprém
      • Veszprem、Veszprém、ハンガリー
  • ポーランド
      • Gdynia、ポーランド
    • Dolnośląskie
      • Wroclaw、Dolnośląskie、ポーランド
    • Lubelskie
      • Lublin、Lubelskie、ポーランド
    • Mazowieckie
      • Warszawa、Mazowieckie、ポーランド
    • Małopolskie
      • Krakow、Małopolskie、ポーランド
    • Opolskie
      • Strzelce Opolskie、Opolskie、ポーランド
    • Podkarpackie
      • Iwonicz Zdroj、Podkarpackie、ポーランド
    • Podlaskie
      • Bialystok、Podlaskie、ポーランド
    • Pomorskie
      • Gdansk、Pomorskie、ポーランド
    • Wielkopolskie
      • Poznan、Wielkopolskie、ポーランド
    • Zachodniopomorskie
      • Szczecin、Zachodniopomorskie、ポーランド
    • Łódzkie
      • Łódź、Łódzkie、ポーランド
    • Śląskie
      • Katowice、Śląskie、ポーランド
    • Świętokrzyskie
      • Skarzysko-Kamienna、Świętokrzyskie、ポーランド
  • ルーマニア
    • Braşov
      • Brasov、Braşov、ルーマニア
    • Bucureşti
      • Bucuresti、Bucureşti、ルーマニア
    • Cluj
      • Cluj-Napoca、Cluj、ルーマニア
    • Dolj
      • Craiova、Dolj、ルーマニア
    • Mureş
      • Targu Mures、Mureş、ルーマニア
  • 大韓民国
      • Seodaemun-gu、大韓民国
      • Uijeongbu-si、大韓民国
    • Gyeonggido
      • Bucheon-si、Gyeonggido、大韓民国
      • Suwon、Gyeonggido、大韓民国
    • Seoul Teugbyeolsi
      • Seoul、Seoul Teugbyeolsi、大韓民国
  • 日本
      • Fukuoka、日本
    • Fukuoka
      • Kitakyushu、Fukuoka、日本
    • Hyôgo
      • Amagasaki、Hyôgo、日本
    • Kanagawa
      • Yokohama、Kanagawa、日本
    • Kumamoto
      • Kamimashiki-gun、Kumamoto、日本
    • Saitama
      • Saitama-shi、Saitama、日本
    • Shizuoka
      • Yaizu、Shizuoka、日本
    • Tokyo
      • Koto-ku、Tokyo、日本
      • Setagaya-ku、Tokyo、日本
    • Tôkyô
      • Adachi-ku、Tôkyô、日本
      • Chiyoda-ku、Tôkyô、日本
      • Nakano-ku、Tôkyô、日本
      • Nerima-ku、Tôkyô、日本
      • Shibuya-ku、Tôkyô、日本
      • Shinagawa-ku、Tôkyô、日本
      • Shinjuku-ku、Tôkyô、日本
      • Suginami-ku、Tôkyô、日本

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

Key Inclusion Criteria:

  1. Chronic AD that had been present for at least 3 years before the screening visit;
  2. Documented recent history (within 6 months before the screening visit) of inadequate response to a sufficient course of out-patient treatment with topical AD medication(s).

Key Exclusion Criteria:

  1. Participation in a prior Dupilumab clinical trial;
  2. Important side effects of topical medication (e.g. intolerance to treatment, hypersensitivity reactions, significant skin atrophy, systemic effects), as assessed by the investigator or treating physician;

  3. Having used any of the following treatments within 4 weeks before the baseline visit, or any condition that, in the opinion of the investigator, was likely to require such treatment(s) during the first 2 weeks of study treatment:

    1. Immunosuppressive/immunomodulating drugs (e.g, systemic steroids, cyclosporine, mycophenolate-mofetil, Janus kinase inhibitors, interferon-gamma [IFN-γ], azathioprine, methotrexate, etc.);
    2. Phototherapy for AD;
  4. Treatment with a live (attenuated) vaccine within 12 weeks before the baseline visit;
  5. History of human immunodeficiency virus (HIV) infection or positive HIV serology at screening;
  6. Positive hepatitis B surface antigen (HBsAg), hepatitis B core antibody (HBcAb), or hepatitis C antibody at the screening visit;
  7. Active or acute infection requiring systemic treatment within 2 weeks before baseline visit;
  8. Known or suspected history of immunosuppression;
  9. Pregnant or breastfeeding women, or planning to become pregnant or breastfeed during the participant's participation in this study.

Note: The eligibility criteria listed above is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial therefore not all inclusion/ exclusion criteria are listed.

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：トリプル

武器と介入

参加者グループ / アーム
介入・治療
実験的：Placebo qw
Two subcutaneous injections of Placebo (for Dupilumab) as a loading dose on Day 1 followed by a single injection weekly (qw) from Week 1 to Week 51.
薬：Placebo (for Dupilumab)
Subcutaneous injection in the different quadrants of the abdomen (avoiding navel and waist areas) and upper thighs
他の：Topical Corticosteroid (TCS)
All participants were required to treatment with a (TCS) using a standardized regimen. It was recommended that participants use triamcinolone acetonide 0.1% cream or fluocinolone acetonide 0.025% ointment for medium potency, and hydrocortisone 1% cream for low potency.
実験的：Dupilumab 300 mg q2w
Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by placebo (for Dupilumab) alternating with single 300 mg injection of Dupilumab every 2 weeks (q2w) from Week 1 to Week 51. During weeks in which Dupilumab was not administered, participants received placebo.
薬：Placebo (for Dupilumab)
Subcutaneous injection in the different quadrants of the abdomen (avoiding navel and waist areas) and upper thighs
他の：Topical Corticosteroid (TCS)
All participants were required to treatment with a (TCS) using a standardized regimen. It was recommended that participants use triamcinolone acetonide 0.1% cream or fluocinolone acetonide 0.025% ointment for medium potency, and hydrocortisone 1% cream for low potency.
薬：Dupilumab
Subcutaneous injection in the different quadrants of the abdomen (avoiding navel and waist areas) and upper thighs
他の名前：
  • デュピクセント
  • REGN668
  • SAR231893
実験的：Dupilumab 300 mg qw
Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by a single 300 mg injection of Dupilumab qw from Week 1 to Week 51.
他の：Topical Corticosteroid (TCS)
All participants were required to treatment with a (TCS) using a standardized regimen. It was recommended that participants use triamcinolone acetonide 0.1% cream or fluocinolone acetonide 0.025% ointment for medium potency, and hydrocortisone 1% cream for low potency.
薬：Dupilumab
Subcutaneous injection in the different quadrants of the abdomen (avoiding navel and waist areas) and upper thighs
他の名前：
  • デュピクセント
  • REGN668
  • SAR231893

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
Percentage of Participants With Investigator's Global Assessment (IGA) Score of "0" or "1" and Reduction From Baseline of ≥2 Points at Week 16
時間枠：Baseline to Week 16
IGA is an assessment scale used to determine severity of AD and clinical response to treatment on a 5-point scale (0 = clear; 1 = almost clear; 2 = mild; 3 = moderate; 4 = severe) based on erythema and papulation/infiltration. Therapeutic response is an IGA score of 0 (clear) or 1 (almost clear). Participants with IGA score "0" or "1" and a reduction from baseline of ≥2 points at Week 16 were reported.
Baseline to Week 16

二次結果の測定

結果測定
メジャーの説明
時間枠
湿疹領域および重症度指数（EASI）スコアのベースラインから16週までの変化率
時間枠：16週目までのベースライン
EASI スコアを使用して、AD の重症度と程度を測定し、身体の 4 つの解剖学的領域 (頭、体幹、上肢、下肢) で紅斑、浸潤、剥脱、苔癬化を測定しました。 合計 EASI スコアは 0 (最小) から 72 (最大) ポイントの範囲であり、スコアが高いほど AD の重症度が悪いことを反映しています。
16週目までのベースライン
Percentage of Participants With Eczema Area and Severity Index-75 (EASI-75) (≥75% Improvement From Baseline) at Week 16
時間枠：Baseline to Week 16
The EASI score was used to measure the severity and extent of atopic dermatitis (AD) and measures erythema, infiltration, excoriation and lichenification on 4 anatomic regions of the body: head, trunk, upper and lower extremities. The total EASI score ranges from 0 (minimum) to 72 (maximum) points, with the higher scores reflecting the worse severity of AD. EASI-75 responders were the participants who achieved ≥75% overall improvement in EASI score from baseline to Week 16.
Baseline to Week 16
Percentage of Participants With Improvement (Reduction ≥4 Points) of Weekly Average of Peak Daily Pruritus Numerical Rating Scale (NRS) Score From Baseline to Week 16
時間枠：Baseline to Week 16
Pruritus NRS was an assessment tool that was used to report the intensity of a participant's pruritus (itch), both maximum and average intensity, during a 24-hour recall period. Participants were asked the following question: how would a participant rate his itch at the worst moment during the previous 24 hours (for maximum itch intensity on a scale of 0 - 10 [0 = no itch; 10 = worst itch imaginable]). Participants achieving a reduction of ≥4 points from baseline in weekly average of peak daily pruritus NRS score at Week 16 were reported.
Baseline to Week 16
Percentage of Participants With Improvement (Reduction ≥3 Points) of Weekly Average of Peak Daily Pruritus Numerical Rating Scale (NRS) Score From Baseline to Week 16
時間枠：Baseline to Week 16
Pruritus NRS was an assessment tool that was used to report the intensity of a participant's pruritus (itch), both maximum and average intensity, during a 24-hour recall period. Participants were asked the following question: how would a participant rate his itch at the worst moment during the previous 24 hours (for maximum itch intensity on a scale of 0 - 10 [0 = no itch; 10 = worst itch imaginable]). Participants achieving a reduction of ≥3 points from baseline in weekly average of peak daily pruritus NRS score at Week 16 were reported.
Baseline to Week 16
Percentage of Participants With Investigator's Global Assessment (IGA) Score of "0" or "1" and Reduction From Baseline of ≥2 Points at Week 52
時間枠：Baseline to Week 52
IGA is an assessment scale used to determine severity of AD and clinical response to treatment on a 5-point scale (0 = clear; 1 = almost clear; 2 = mild; 3 = moderate; 4 = severe) based on erythema and papulation/infiltration. Therapeutic response is an IGA score of 0 (clear) or 1 (almost clear). Participants with IGA score of "0" or "1" and a reduction from baseline of ≥2 points at Week 52 were reported.
Baseline to Week 52
Percentage of Participants With Eczema Area and Severity Index-75 (EASI-75) (≥75% Improvement From Baseline) at Week 52
時間枠：Baseline to Week 52
The EASI score was used to measure the severity and extent of AD and measured erythema, infiltration, excoriation and lichenification on 4 anatomic regions of the body: head, trunk, upper and lower extremities. The total EASI score ranges from 0 (minimum) to 72 (maximum) points, with the higher scores reflecting the worse severity of AD. EASI-75 responders were the participants who achieved ≥75% overall improvement in EASI score from baseline to Week 52.
Baseline to Week 52
Percent Change From Baseline in Weekly Average of Peak Daily Pruritus Numerical Rating Scale (NRS) Score to Week 16
時間枠：Baseline to Week 16
Pruritus NRS was an assessment tool that was used to report the intensity of a participant's pruritus (itch), both maximum and average intensity, during a 24-hour recall period. Participants were asked the following question: how would a participant rate his itch at the worst moment during the previous 24 hours (for maximum itch intensity on a scale of 0 - 10 [0 = no itch; 10 = worst itch imaginable]).
Baseline to Week 16
Percentage of Participants With Improvement (Reduction ≥4 Points) of Weekly Average of Peak Daily Pruritus Numerical Rating Scale (NRS) Score From Baseline to Week 52
時間枠：Baseline to Week 52
Pruritus NRS was an assessment tool that was used to report the intensity of a participant's pruritus (itch), both maximum and average intensity, during a 24-hour recall period. Participants were asked the following question: how would a participant rate his itch at the worst moment during the previous 24 hours (for maximum itch intensity on a scale of 0 - 10 [0 = no itch; 10 = worst itch imaginable]). Participants achieving a reduction of ≥4 points from baseline in weekly average of peak daily pruritus NRS score at Week 52 were reported.
Baseline to Week 52
Percentage of Participants With Improvement (Reduction ≥3 Points) of Weekly Average of Peak Daily Pruritus Numerical Rating Scale (NRS) Score From Baseline to Week 52
時間枠：Baseline to Week 52
Pruritus NRS was an assessment tool that was used to report the intensity of a participant's pruritus (itch), both maximum and average intensity, during a 24-hour recall period. Participants were asked the following question: how would a participant rate his itch at the worst moment during the previous 24 hours (for maximum itch intensity on a scale of 0 - 10 [0 = no itch; 10 = worst itch imaginable]). Participants achieving a reduction of ≥3 points from baseline in weekly average of peak daily pruritus NRS score at Week 52 were reported.
Baseline to Week 52
Percentage of Participants With Improvement (Reduction ≥4 Points) of Weekly Average of Peak Daily Pruritus Numerical Rating Scale (NRS) Score From Baseline to Week 24
時間枠：Baseline to Week 24
Pruritus NRS was an assessment tool that was used to report the intensity of a participant's pruritus (itch), both maximum and average intensity, during a 24-hour recall period. Participants were asked the following question: how would a participant rate his itch at the worst moment during the previous 24 hours (for maximum itch intensity on a scale of 0 - 10 [0 = no itch; 10 = worst itch imaginable]). Participants achieving a reduction of ≥4 points from baseline in weekly average of peak daily pruritus NRS score at Week 24 were reported.
Baseline to Week 24
Percentage of Participants With Improvement (Reduction ≥4 Points) of Weekly Average of Peak Daily Pruritus Numerical Rating Scale (NRS) Score From Baseline to Week 4
時間枠：Baseline to Week 4
Pruritus NRS was an assessment tool that was used to report the intensity of a participant's pruritus (itch), both maximum and average intensity, during a 24-hour recall period. Participants were asked the following question: how would a participant rate his itch at the worst moment during the previous 24 hours (for maximum itch intensity on a scale of 0 - 10 [0 = no itch; 10 = worst itch imaginable]). Participants achieving a reduction of ≥4 points from baseline in weekly average of peak daily pruritus NRS score at Week 4 were reported.
Baseline to Week 4
Percentage of Participants With Improvement (Reduction ≥4 Points) of Weekly Average of Peak Daily Pruritus Numerical Rating Scale (NRS) Score From Baseline to Week 2
時間枠：Baseline to Week 2
Pruritus NRS was an assessment tool that was used to report the intensity of a participant's pruritus (itch), both maximum and average intensity, during a 24-hour recall period. Participants were asked the following question: how would a participant rate his itch at the worst moment during the previous 24 hours (for maximum itch intensity on a scale of 0 - 10 [0 = no itch; 10 = worst itch imaginable]). Participants achieving a reduction of ≥4 points from baseline in weekly average of peak daily pruritus NRS score at Week 2 were reported.
Baseline to Week 2
Change From Baseline in Weekly Average of Peak Daily Pruritus Numerical Rating Scale (NRS) Score to Week 16
時間枠：Baseline to Week 16
Pruritus NRS was an assessment tool that was used to report the intensity of a participant's pruritus (itch), both maximum and average intensity, during a 24-hour recall period. Participants were asked the following question: how would a participant rate his itch at the worst moment during the previous 24 hours (for maximum itch intensity on a scale of 0 - 10 [0 = no itch; 10 = worst itch imaginable]).
Baseline to Week 16
Change From Baseline in Percent Body Surface Area (BSA) Affected by Atopic Dermatitis to Week 16
時間枠：Baseline to Week 16
BSA affected by AD was assessed for each section of the body (the possible highest score for each region was: head and neck [9%], anterior trunk [18%], back [18%], upper limbs [18%], lower limbs [36%], and genitals [1%]). It was reported as a percentage of all major body sections combined.
Baseline to Week 16
Percent Change From Baseline in the SCORing Atopic Dermatitis (SCORAD) Score to Week 16
時間枠：Baseline to Week 16
SCORAD was a clinical tool for assessing the severity of AD developed by the European Task Force on Atopic Dermatitis (Severity scoring of atopic dermatitis: the SCORAD index). Consensus Report of the European Task Force on Atopic Dermatitis. Dermatology (Basel) 186 (1): 23-31. 1993. Extent and intensity of eczema as well as subjective signs (insomnia, etc.) were assessed and scored. Total score ranges from 0 (absent disease) to 103 (severe disease).
Baseline to Week 16
Change From Baseline in Dermatology Life Quality Index (DLQI) to Week 16
時間枠：Baseline to Week 16
The DLQI was a 10-item, validated questionnaire used in clinical practice and clinical trials to assess the impact of AD disease symptoms and treatment on quality of life (QOL). The 10 questions assessed QOL over the past week, with an overall scoring of 0 (absent disease) to 30 (severe disease); a high score was indicative of a poor QOL.
Baseline to Week 16
Change From Baseline in Patient Oriented Eczema Measure (POEM) to Week 16
時間枠：Baseline to Week 16
The POEM was a 7-item questionnaire that assessed disease symptoms (dryness, itching, flaking, cracking, sleep loss, bleeding and weeping) with a scoring system of 0 (absent disease) to 28 (severe disease) (high score indicative of poor quality of life [QOL]).
Baseline to Week 16
Change From Baseline in Hospital Anxiety Depression Scale (HADS) to Week 16
時間枠：Baseline to Week 16
HADS is a fourteen item scale. Seven of the items relate to anxiety and seven items relate to depression. Each item on the questionnaire scored from 0 (minimum score) - 3 (maximum score) and this means that a person can score between 0 (no symptoms) and 21 (severe symptoms) for either anxiety or depression. Cut-offs for identifying psychiatric distress has been reported as 7 to 8 for possible presence, 10 to 11 for probable presence, and 14 to 15 for severe anxiety or depression.
Baseline to Week 16
Percent Change From Baseline in Total Global Individual Signs Score (GISS) to Week 16
時間枠：Baseline to Week 16
Individual components of the AD lesions (erythema, infiltration/ papulation, excoriations, and lichenification) were rated globally (each assessed for the whole body, not by anatomical region) on a 4-point scale (0= none, 1= mild, 2= moderate and 3= severe) using the EASI severity grading criteria. Total score ranges from 0 (absent disease) to 12 (severe disease).
Baseline to Week 16
Proportion of Topical Atopic Dermatitis Medication-Free Days Through Week 52
時間枠：Baseline to Week 52
Proportion of topical AD medication-free days through Week 52 was calculated as the number of days that a participant used neither topical corticosteroid (TCS)/ topical calcineurin inhibitors (TCI) nor system rescue therapy divided by the study days of each period.
Baseline to Week 52
Percent Change From Baseline in Weekly Average of Peak Daily Pruritus Numerical Rating Scale (NRS) Score to Week 2
時間枠：Baseline to Week 2
Pruritus NRS was an assessment tool that was used to report the intensity of a participant's pruritus (itch), both maximum and average intensity, during a 24-hour recall period. Participants were asked the following question: how would a participant rate his itch at the worst moment during the previous 24 hours (for maximum itch intensity on a scale of 0 - 10 [0 = no itch; 10 = worst itch imaginable]).
Baseline to Week 2
Percent Change From Baseline in Eczema Area and Severity Index (EASI) Score to Week 52
時間枠：Baseline to Week 52
The EASI score was used to measure the severity and extent of AD and measured erythema, infiltration, excoriation and lichenification on 4 anatomic regions of the body: head, trunk, upper and lower extremities. The total EASI score ranges from 0 (minimum) to 72 (maximum) points, with the higher scores reflecting the worse severity of AD.
Baseline to Week 52
Change From Baseline in Percent Body Surface Area (BSA) Affected by Atopic Dermatitis to Week 52
時間枠：Baseline to Week 52
BSA affected by AD was assessed for each section of the body (the possible highest score for each region was: head and neck [9%], anterior trunk [18%], back [18%], upper limbs [18%], lower limbs [36%], and genitals [1%]). It was reported as a percentage of all major body sections combined.
Baseline to Week 52
Percent Change From Baseline in the SCORing Atopic Dermatitis (SCORAD) Score to Week 52
時間枠：Baseline to Week 52
SCORAD was a clinical tool for assessing the severity of AD developed by the European Task Force on Atopic Dermatitis (Severity scoring of atopic dermatitis: the SCORAD index). Consensus Report of the European Task Force on Atopic Dermatitis. Dermatology (Basel) 186 (1): 23-31. 1993. Extent and intensity of eczema as well as subjective signs (insomnia, etc.) were assessed and scored. Total score ranges from 0 (absent disease) to 103 (severe disease).
Baseline to Week 52
Percent Change From Baseline in Global Individual Signs Score (GISS) to Week 52
時間枠：Baseline to Week 52
Individual components of the AD lesions (erythema, infiltration/ papulation, excoriations, and lichenification) were rated globally (each assessed for the whole body, not by anatomical region) on a 4-point scale (0= none, 1= mild, 2= moderate and 3= severe) using the EASI severity grading criteria. Total score ranges from 0 (absent disease) to 12 (severe disease).
Baseline to Week 52
Change From Baseline in Dermatology Life Quality Index (DLQI) to Week 52
時間枠：Baseline to Week 52
The DLQI was a 10-item, validated questionnaire used in clinical practice and clinical trials to assess the impact of AD disease symptoms and treatment on quality of life (QOL). The 10 questions assessed QOL over the past week, with an overall scoring of 0 (absent disease) to 30 (severe disease); a high score was indicative of a poor QOL.
Baseline to Week 52
Change From Baseline in Patient Oriented Eczema Measure (POEM) to Week 52
時間枠：Baseline to Week 52
The POEM was a 7-item questionnaire that assesses disease symptoms (dryness, itching, flaking, cracking, sleep loss, bleeding and weeping) with a scoring system of 0 (absent disease) to 28 (severe disease) (high score indicative of poor quality of life [QOL]).
Baseline to Week 52
Change From Baseline in Hospital Anxiety Depression Scale (HADS) to Week 52
時間枠：Baseline to Week 52
HADS is a fourteen item scale. Seven of the items relate to anxiety and seven items relate to depression. Each item on the questionnaire is scored from 0 (minimum score) - 3 (maximum score) and this means that a person can score between 0 (no symptoms) and 21 (severe symptoms) for either anxiety or depression. Cut-offs for identifying psychiatric distress has been reported as 7 to 8 for possible presence, 10 to 11 for probable presence, and 14 to 15 for severe anxiety or depression.
Baseline to Week 52
Number of Flares Through Week 52
時間枠：Baseline up to Week 52
Atopic dermatitis (AD) flares were defined as worsening of the disease that required escalation/intensification of AD treatment. Number of flares occurred in the participants starting from first dose through Week 52 were reported.
Baseline up to Week 52
Number of Serious Treatment Emergent Adverse Events (TEAEs) Leading to Study Drug Discontinuation Through Week 52
時間枠：Baseline up to Week 52
Any untoward medical occurrence in a participant who received investigational medicinal product (IMP) was considered an AE without regard to possibility of causal relationship with this treatment. A Serious adverse event (SAE) was defined as any untoward medical occurrence that resulted in any of the following outcomes: death, life-threatening, required initial or prolonged in-patient hospitalization, persistent or significant disability/incapacity, congenital anomaly/birth defect, or considered as medically important event. Any TEAE included participants with both serious and non-serious AEs.
Baseline up to Week 52
Percentage of Participants With Skin Infection Treatment Emergent Adverse Events (TEAEs) (Excluding Herpetic Infections) From Baseline Through Week 52
時間枠：Baseline up to Week 52
Any untoward medical occurrence in a participants who received IMP was considered an AE without regard to possibility of causal relationship with this treatment. TEAEs were defined as AEs that developed or worsened or became serious during on-treatment period (time from the first dose of study drug up to end of treatment at Week 52). Any TEAE included participants with both serious and non-serious AEs. Skin infection TEAEs were identified based on blinded adjudication of all reported TEAEs under the 2 primary System Organ Classes (SOC): SOC = "Infection and Infestations" or SOC = "Skin and Subcutaneous Tissue Disorders". Blinded adjudication was performed and finalized by the study medical monitor before database lock.
Baseline up to Week 52
Number of Skin Infection TEAEs (Excluding Herpetic Infections) From Baseline Through Week 52
時間枠：Baseline up to Week 52
Any untoward medical occurrence in a participant who received IMP was considered an AE without regard to possibility of causal relationship with this treatment. TEAEs were defined as AEs that developed or worsened or became serious during on-treatment period (time from the first dose of study drug up to end of treatment at Week 52). Any TEAE included participants with both serious and non-serious AEs. Skin infection TEAEs were identified based on blinded adjudication of all reported TEAEs under the 2 primary System Organ Classes (SOC): SOC = "Infection and Infestations" or SOC = "Skin and Subcutaneous Tissue Disorders". Blinded adjudication was performed and finalized by the study medical monitor before database lock.
Baseline up to Week 52
Percentage of Participants With Skin Infection Treatment Emergent Adverse Events (TEAEs) (Excluding Herpetic Infections) Requiring Systemic Treatment From Baseline Through Week 52
時間枠：Baseline up to Week 52
Any untoward medical occurrence in a participant who received IMP was considered an AE without regard to possibility of causal relationship with this treatment. TEAEs were defined as AEs that developed or worsened or became serious during on-treatment period (time from the first dose of study drug up to end of treatment at Week 52). Any TEAE included participants with both serious and non-serious AEs. Skin infection TEAEs were identified based on blinded adjudication of all reported TEAEs under the 2 primary System Organ Classes (SOC): SOC = "Infection and Infestations" or SOC = "Skin and Subcutaneous Tissue Disorders". Blinded adjudication was performed and finalized by the study medical monitor before database lock.
Baseline up to Week 52
Number of Skin Infection Treatment Emergent Adverse Events (TEAEs) (Excluding Herpetic Infections) Requiring Systemic Treatment From Baseline Through Week 52
時間枠：Baseline up to Week 52
Any untoward medical occurrence in a participant who received IMP was considered an AE without regard to possibility of causal relationship with this treatment. TEAEs were defined as AEs that developed or worsened or became serious during on-treatment period (time from the first dose of study drug up to end of treatment at Week 52). Any TEAE included participants with both serious and non-serious AEs. Skin infection TEAEs were identified based on blinded adjudication of all reported TEAEs under the 2 primary System Organ Classes (SOC): SOC = "Infection and Infestations" or SOC = "Skin and Subcutaneous Tissue Disorders". Blinded adjudication was performed and finalized by the study medical monitor before database lock.
Baseline up to Week 52

その他の成果指標

結果測定
メジャーの説明
時間枠
Change From Baseline in Sinonasal Outcome Test (SNOT-22) Score to Week 16
時間枠：Baseline to Week 16
The SNOT 22 was a validated measure of health related quality of life in sinonasal disease. It was a 22 item questionnaire with each item assigned a score ranging from 0-5. The total score may range from 0 (no disease) -110 (worst disease) (lower scores represent better health related quality of life). The SNOT-22 was administered only to participants with chronic inflammatory conditions of the nasal mucosa and/or paranasal sinuses.
Baseline to Week 16
Change From Baseline in Asthma Control Questionnaire-5 (ACQ-5) Score to Week 16
時間枠：Baseline to Week 16
ACQ-5 questionnaire was a validated questionnaire comprising of 5 questions for asthma symptoms: woken at night by symptoms, wake in the mornings with symptoms, limitation of daily activities, shortness of breath, and wheeze. Participants were asked to rate their asthma symptoms during the previous week on a 7-point scale as 0=no impairment, 6=maximum impairment. ACQ-5 score was the mean of the 5 questions and range between 0 (totally controlled) and 6 (severely uncontrolled) (a higher score indicated lower asthma control). The ACQ-5 questionnaire was administered only to the participants with a medical history of asthma.
Baseline to Week 16

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

Regeneron Pharmaceuticals

協力者

Sanofi

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

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

2014年9月1日

一次修了 (実際)

2015年8月1日

研究の完了 (実際)

2016年10月1日

試験登録日

最初に提出

2014年10月6日

QC基準を満たした最初の提出物

2014年10月6日

最初の投稿 (見積もり)

2014年10月9日

学習記録の更新

投稿された最後の更新 (実際)

2017年10月17日

QC基準を満たした最後の更新が送信されました

2017年10月12日

最終確認日

2017年10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

  • R668-AD-1224

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