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Study to Evaluate the Efficacy and Safety of MEDI-563 in Adults With Uncontrolled Asthma

2016年9月28日 更新者：MedImmune LLC

A Phase 2b, Dose-ranging Study to Evaluate the Efficacy and Safety of MEDI-563 in Adults With Uncontrolled Asthma

The primary objective of the study is to evaluate the effect of multiple-dose subcutaneous administrations of MEDI-563 on adults with uncontrolled asthma.

調査の概要

状態

完了

条件

介入・治療

詳細な説明

This is a Phase 2b, randomized, double-blind, placebo-controlled, dose-ranging study to evaluate the efficacy and safety of multiple-dose (7 doses) subcutaneous administration of benralizumab (MEDI-563) in adult subjects with uncontrolled asthma.

研究の種類

介入

入学 (実際)

964

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

  • アメリカ
    • Alabama
      • Birmingham、Alabama、アメリカ
        • Research Site
    • California
      • Los Angeles、California、アメリカ
        • Research Site
      • Orange、California、アメリカ
        • Research Site
      • San Diego、California、アメリカ
        • Research Site
      • Stockton、California、アメリカ
        • Research Site
    • Colorado
      • Colorado Springs、Colorado、アメリカ
        • Research Site
      • Denver、Colorado、アメリカ
        • Research Site
    • Connecticut
      • Waterbury、Connecticut、アメリカ
        • Research Site
    • Florida
      • Kissimmee、Florida、アメリカ
        • Research Site
      • Tampa、Florida、アメリカ
        • Research Site
    • Georgia
      • Stockbridge、Georgia、アメリカ
        • Research Site
    • Illinois
      • Normal、Illinois、アメリカ
        • Research Site
    • Maryland
      • Baltimore、Maryland、アメリカ
        • Research Site
    • Minnesota
      • Rochester、Minnesota、アメリカ
        • Research Site
    • Missouri
      • St Louis、Missouri、アメリカ
        • Research Site
      • St. Louis、Missouri、アメリカ
        • Research Site
    • Nebraska
      • Bellevue、Nebraska、アメリカ
        • Research Site
    • New Jersey
      • Summit、New Jersey、アメリカ
        • Research Site
    • New York
      • Rochester、New York、アメリカ
        • Research Site
    • North Carolina
      • Winston-Salem、North Carolina、アメリカ
        • Research Site
    • Ohio
      • Cincinnati、Ohio、アメリカ
        • Research Site
    • Oklahoma
      • Oklahoma City、Oklahoma、アメリカ
        • Research Site
    • Pennsylvania
      • Blue Bell、Pennsylvania、アメリカ
        • Research Site
      • Pittsburgh、Pennsylvania、アメリカ
        • Research Site
    • Rhode Island
      • Warwick、Rhode Island、アメリカ
        • Research Site
    • Texas
      • Boerne、Texas、アメリカ
        • Research Site
      • San Antonio、Texas、アメリカ
        • Research Site
    • Washington
      • Seattle、Washington、アメリカ
        • Research Site
  • アルゼンチン
      • Caba、アルゼンチン
        • Research Site
      • Ciudad de Buenos Aires、アルゼンチン
        • Research Site
      • Santa Fe、アルゼンチン
        • Research Site
      • Tucumán、アルゼンチン
        • Research Site
  • カナダ
      • Quebec、カナダ
        • Research Site
    • Ontario
      • Brampton、Ontario、カナダ
        • Research Site
      • Toronto、Ontario、カナダ
        • Research Site
    • Quebec
      • La Malbaie、Quebec、カナダ
        • Research Site
  • コロンビア
      • Bogota、コロンビア
        • Research Site
      • Bogotá、コロンビア
        • Research Site
  • ブラジル
      • Curitiba、ブラジル
        • Research Site
      • Florianópolis、ブラジル
        • Research Site
      • Juiz de Fora、ブラジル
        • Research Site
      • Porto Alegre、ブラジル
        • Research Site
      • Rio de Janeiro、ブラジル
        • Research Site
      • Salvador、ブラジル
        • Research Site
      • Santo André、ブラジル
        • Research Site
      • Sao Paulo、ブラジル
        • Research Site
      • São Paulo、ブラジル
        • Research Site
  • ブルガリア
      • Pleven、ブルガリア
        • Research Site
      • Ruse、ブルガリア
        • Research Site
      • Sofia、ブルガリア
        • Research Site
      • Troyan、ブルガリア
        • Research Site
  • ペルー
      • Lima、ペルー
        • Research Site
      • San Borja、ペルー
        • Research Site
      • San Isidro、ペルー
        • Research Site
      • Surco、ペルー
        • Research Site
  • ポーランド
      • Białystok、ポーランド
        • Research Site
      • Bydgoszcz、ポーランド
        • Research Site
      • Lublin、ポーランド
        • Research Site
      • Ostrów Wielkopolski、ポーランド
        • Research Site
      • Pila、ポーランド
        • Research Site
      • Poznań、ポーランド
        • Research Site
      • Tarnów、ポーランド
        • Research Site
      • Warszawa、ポーランド
        • Research Site
      • Łódź、ポーランド
        • Research Site
  • メキシコ
      • Guadalajara、メキシコ
        • Research Site
      • Mexico、メキシコ
        • Research Site
      • Monterrey、メキシコ
        • Research Site
      • Morelia、メキシコ
        • Research Site
      • Villahermosa、メキシコ
        • Research Site
      • Zapopan、メキシコ
        • Research Site
  • ロシア連邦
      • Barnaul、ロシア連邦
        • Research Site
      • Chelyabinsk、ロシア連邦
        • Research Site
      • Ekaterinburg、ロシア連邦
        • Research Site
      • Kazan、ロシア連邦
        • Research Site
      • Moscow、ロシア連邦
        • Research Site
      • Novosibirsk、ロシア連邦
        • Research Site
      • Saint Petersburg、ロシア連邦
        • Research Site
      • Saint-Petersburg、ロシア連邦
        • Research Site
      • St-Petersburg、ロシア連邦
        • Research Site

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～75年 (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:

  • Age 18 through 75 years at the time of screening
  • Adequate contraception from screening through end of trial
  • Weight of more than (>) 45 kilogram (kg) but less than or equal to (<=) 150 kg (>100 pound [lb] but <=330 lb)
  • History of physician-diagnosed asthma for at least 12 months prior to screening
  • Physician prescribed daily use of medium-dose or high-dose inhaled corticosteroid(s) (ICS) plus long-acting beta 2 agonist (LABA) for at least 12 months prior to screening
  • Willingness to switch to an ICS/LABA combination product
  • Dose of other asthma controller medications must be stable for at least 30 days prior to screening
  • At least 2 documented asthma exacerbations in the 12 months prior to screening that required use of a systemic corticosteroid burst
  • For subjects 65 years of age or older, a chest x-ray (CXR) or chest computed tomography (CT) that is normal for an asthmatic population
  • Ability and willingness to complete the study to Week 66, and if needed to Week 92.

Exclusion Criteria:

  • Known history of allergy or reaction to any component of the investigational product formulation
  • History of anaphylaxis to any biologic therapy
  • Unexplained diarrhea within 30 days prior to screening or diagnosis of helminth parasitic infestation within 6 months prior to screening
  • Use of immunosuppressive medication within 3 months prior to screening. Chronic oral prednisone or equivalent up to 10 milligram (mg) daily or 20 mg every other day for asthma is allowed
  • Oral corticosteroid burst or short-acting systemic corticosteroid within 30 days prior to screening or during the screening/run-in period
  • Acute upper or lower respiratory infections requiring antibiotics or antiviral medications within 30 days prior to the screening or during the screening/run-in period
  • Receipt of immunoglobulin or blood products within 30 days prior to screening
  • Receipt of any marketed or investigational biologic within 4 months or 5 half-lives prior to screening, whichever is longer
  • Receipt of any investigational nonbiologic within 30 days or 5 half-lives prior to screening, whichever is longer
  • Previously received MEDI-563
  • Any clinically relevant abnormal findings in physical examination
  • Past history of clinically significant cardiac disease or any electrocardiogram (ECG) abnormality
  • Breastfeeding or lactating women
  • History of alcohol or drug abuse within 12 months prior to screening
  • History of any known primary immunodeficiency disorder
  • Positive medical history for hepatitis B or C. Subjects with a history of hepatitis B vaccination without history of hepatitis B are allowed to enrol
  • A positive human immunodeficiency virus (HIV) test or subject taking antiretroviral medications
  • History of cigarette smoking more than or equal to (>=) 10 pack-years or smoking within 12 months prior to screening.
  • Known exposure to inhaled occupational agents or fumes with an established diagnosis of occupational asthma
  • History of cancer, except for basal cell carcinoma or in situ carcinoma of the cervix treated with apparent success with curative therapy >=12 months prior to screening or other malignancies treated with apparent success with curative therapy >=5 years prior to screening
  • Stable dose of allergy vaccination regimen for less than 30 days prior to screening
  • Subjects unable to demonstrate acceptable inhaler and peak flow meter techniques.

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
プラセボコンパレーター：Eosinophilic phenotype (EOS+) Placebo
EOS+ (defined as ELEN Index [proprietary mathematical algorithm to predict sputum eosinophil's greater than or equal to 2 percent] positive and/or FeNO [fraction of exhaled nitric oxide] greater than or equal to [>=] 50 parts per billion [ppb]) participants received matching placebo injections subcutaneous injection every 4 weeks for first 3 doses and then every 8 weeks for next 4 doses up to Week 40.
他の：Placebo
EOS+ and EOS- participants received two placebo injections subcutaneously.
実験的：EOS+ Benralizumab (2 mg)
EOS+ participants received single benralizumab 2 milligram (mg) injection subcutaneously every 4 weeks for first 3 doses and then every 8 weeks for next 4 doses up to Week 40.
生物学的：Benralizumab 2 mg
EOS+ participants received single benralizumab 2 milligram (mg) injection followed by a single placebo injection subcutaneously.
他の名前：
  • MEDI-563
実験的：EOS+ Benralizumab (20 mg)
EOS+ participants received single benralizumab 20 mg injection subcutaneously every 4 weeks for first 3 doses and then every 8 weeks for next 4 doses up to Week 40.
生物学的：Benralizumab 20 mg
EOS+ participants received single benralizumab 20 mg injection followed by a single placebo injection subcutaneously.
他の名前：
  • MEDI-563
実験的：EOS+ Benralizumab (100 mg)
EOS+ participants received benralizumab 50 mg as two injections subcutaneously every 4 weeks for first 3 doses and then every 8 weeks for next 4 doses up to Week 40.
生物学的：Benralizumab 100 mg
EOS+ and EOS- participants received two benralizumab 50 mg injections subcutaneously.
他の名前：
  • MEDI-563
プラセボコンパレーター：Non-eosinophil phenotype (EOS-) Placebo
EOS- (defined as ELEN Index negative and FeNO <50 ppb) participants received matching placebo subcutaneous every 4 weeks for first 3 doses and then every 8 weeks for next 4 doses up to Week 40.
他の：Placebo
EOS+ and EOS- participants received two placebo injections subcutaneously.
実験的：EOS- Benralizumab (100 mg)
EOS- participants received benralizumab 50 mg as two injections subcutaneously every 4 weeks for first 3 doses and then every 8 weeks for next 4 doses up to Week 40.
生物学的：Benralizumab 100 mg
EOS+ and EOS- participants received two benralizumab 50 mg injections subcutaneously.
他の名前：
  • MEDI-563

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
Annual Asthma Exacerbation Rate (AER) for Eosinophilic Phenotype (EOS+) Participants
時間枠：Week 1 up to Week 52
The annual asthma exacerbation rate (AER) was calculated as the total number of observed exacerbations in each group up to week 52, divided by total duration of person-year follow-up in each group. An asthma exacerbation is defined as a progressive increase of asthma symptoms (cough, wheeze, chest tightness, and/or shortness of breath) that does not resolve after the initiation of rescue medications and remains troublesome for the participant resulting in either 1) use of systemic corticosteroids or increase of a stable systemic maintenance dose for a duration of at least 3 days as prescribed or administered by the investigator or healthcare provider; or 2) participant initiation of systemic corticosteroids (tablets, suspension or injection) for a duration of at least 3 days as outlined in the Asthma Action Plan provided to the participant by the investigator on Day 1.
Week 1 up to Week 52

二次結果の測定

結果測定
メジャーの説明
時間枠
Dose Response in EOS+ Participants
時間枠：Baseline up to Week 66
Baseline up to Week 66
Minimum Observed Serum Trough Concentration for Benralizumab at Steady-State (Ctrough, ss)
時間枠：Pre-dose (0 hour), Post-dose on Day 1, 6, Week 4, 16, 24, 32, 40, and 52
Pre-dose (0 hour), Post-dose on Day 1, 6, Week 4, 16, 24, 32, 40, and 52
Dose-Normalized Minimum Observed Serum Trough Concentration for Benralizumab at Steady-State (Ctrough, ssD)
時間枠：Pre-dose (0 hour), Post-dose on Day 1, 6, Week 4, 16, 24, 32, 40, and 52
Pre-dose (0 hour), Post-dose on Day 1, 6, Week 4, 16, 24, 32, 40, and 52
Percentage of Participants With Anti-Drug Antibodies (ADA) to Benralizumab in Eosinophilic Phenotype (EOS+) Participants
時間枠：Baseline up to Week 92
Immunogenicity assessment included determination of anti-drug (benralizumab) antibodies in serum samples. ADA positive was defined as a titer >=50 at any point in the study. It was observed at baseline and any visit during the study.
Baseline up to Week 92
Change From Baseline in Asthma Control Questionnaire (6-items) (ACQ-6) Score at Week 52
時間枠：Baseline up to Week 52
Asthma Control Questionnaire (ACQ) is a participant-reported questionnaire to assess the asthma control with 6 items assessing night-time waking, symptoms on waking, activity limitation, shortness of breath, wheeze, and rescue short-acting beta agonist use. Each item was rated on a 7-point Likert scale ranging from 0 (no impairment) to 6 (maximum impairment). Overall ACQ score was the mean of the 6 item scores with a score range of 0 (well controlled) to 6 (extremely poor controlled). Data collected on Day 1 prior to dosing was considered as baseline. Results were reported for overall ACQ score. ACQ-6 score was summarized together for all participants.
Baseline up to Week 52
Change From Baseline in Mean Total Nasal Symptoms Score (TNSS) at Week 52
時間枠：Baseline up to Week 52
Total Nasal Symptoms Score (TNSS) is a 3-item questionnaire, the sum of nasal symptoms, namely, nasal obstruction (rhinorrhea), nasal congestion, and nasal itching/sneezing. Each symptom was rated on a scale from 0-3, with 0 representing no symptoms, 1 mild, 2 moderate, and 3 severe symptoms. TNSS score was a summation of the 3 individual nasal symptom. TNSS score could range from 0 to 9 where higher score indicates worsening. Data was summarized by each treatment group. In addition, data was summarized together for "EOS+ and EOS- Placebo" arms and "EOS+ and EOS- benralizumab 100 mg" arms.
Baseline up to Week 52
Change From Baseline in Mean Asthma Symptom Diary Score at Week 51-52
時間枠：Baseline up to Week 51-52
Asthma Symptom Diary included 7 questions about the participant symptom and the overall impact of treatment on the disease during the study period. Mean scores of the 7 questions were calculated to identify asthma symptom-free days. Asthma Symptom Diary Scores were analyzed on a bi-weekly basis and compared to baseline scores. Overall symptom score=(daytime frequency score + daytime severity score + nighttime severity score)/3, where total score ranges from 0 to 9. Higher score represents worsening. Mean asthma symptom diary score were summarized together for all participants. Mean asthma symptom diary score were summarized together for all participants. In addition, data was summarized together for "EOS+ and EOS- Placebo" arms and "EOS+ and EOS- benralizumab 100 mg" arms.
Baseline up to Week 51-52
Change From Baseline in Rescue Medication Use at Week 51-52
時間枠：Baseline up to Week 51-52
Participants were provided inhalers of the same dose (medium- or high-dose) inhaled corticosteroid (ICS) plus long-acting beta antagonist (LABA) combination product as baseline prophylactic medication and continued with same dose throughout the study. Rescue medications such as short-term beta2 agonists were used as first-line treatment for worsening asthma symptoms. Investigator prescribed additional short term asthma controller medications included additional ICS, theophylline, inhaled cromones or antimuscarinics; if asthma symptoms remained mild but not resolved. If asthma symptoms worsened, participants received an oral corticosteroid burst. All rescue medications use with prophylactic medication (+ prophylactic) and without prophylactic medication (- prophylactic) was recorded in asthma symptom dairy by participant. Rescue medication use was analyzed on a bi-weekly basis and compared to baseline scores.
Baseline up to Week 51-52
Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) at Week 52
時間枠：Baseline and Week 52
FEV1 was the maximal volume of air exhaled in the first second of a forced expiration from a position of full inspiration. Data was summarized by each treatment group. In addition, data was summarized together for "EOS+ and EOS- Placebo" arms and "EOS+ and EOS- benralizumab 100 mg" arms.
Baseline and Week 52
Change From Baseline in Mean Forced Vital Capacity (FVC) at Week 52
時間枠：Baseline and Week 52
Forced Vital Capacity (FVC) was the volume of air which can be forcibly exhaled from the lungs after taking the deepest breath possible.
Baseline and Week 52
Change From Baseline in Peak Expiratory Flow (PEF) at Week 52
時間枠：Baseline and Week 52
The PEF is a participant's maximum speed of expiration, as measured with a peak flow meter. Peak flow testing for PEF was performed while sitting or standing prior to using any medication (if needed) for asthma. Home PEF was determined separately for morning and evening, and were averaged for each participant. Data was summarized by each treatment group. In addition, data was summarized together for "EOS+ and EOS- Placebo" arms and "EOS+ and EOS- benralizumab 100 mg" arms.
Baseline and Week 52
Change From Baseline in Asthma Quality of Life Questionnaire (Standardized Version) (AQLQ[S]) Score at Week 52
時間枠：Baseline and Week 52
AQLQ: a 32-item questionnaire evaluating quality of life of participants with asthma including 4 domains (symptoms, activity limitations, emotional function, and environmental stimuli). Participants were asked to recall their experiences during the previous 2 weeks and to score each of the 32 questions on a 7-point scale ranging from 7 (no impairment) to 1 (severe impairment). The overall score was calculated as the mean response to all questions. The 4 domain scores were the means of the responses to the questions in each of the domains. Overall AQLQ score and 4 domain scores ranged from 7 (no impairment) to 1 (severe impairment). The AQLQ(S) responses were categorized as improvement (defined as change from baseline >=0.5), no change (defined as change from baseline >= -0.5 to less than [<] 0.5), and worse (defined as change from baseline < -0.5). Data was summarized by each treatment group.
Baseline and Week 52
Change From Baseline in European Quality of Life - 5 Dimensions (EQ-5D) Health State Evaluation at Week 52
時間枠：Baseline and Week 52
The utility-based EQ-5D questionnaire comprises of two parts and provides a generic measure of health for clinical and economic appraisal. The health state valuation was the summary score of mobility, self-care, usual activities, pain/discomfort and anxiety/depression on a 3 category scale (no problem, moderate problem, severe problems). Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state. Data was summarized by each treatment group. In addition, data was summarized together for "EOS+ and EOS- Placebo" arms and "EOS+ and EOS- benralizumab 100 mg" arms.
Baseline and Week 52
Change From Baseline in EQ-5D Visual Analog Scale (VAS) at Week 52
時間枠：Baseline and Week 52
The utility-based EQ-5D questionnaire comprises of two parts and provides a generic measure of health for clinical and economic appraisal. The EQ-5D VAS was measured from 0 (worst imaginable health state) to 100 (best imaginable health state). Data was summarized by each treatment group. In addition, data was summarized together for "EOS+ and EOS- Placebo" arms and "EOS+ and EOS- benralizumab 100 mg" arms.
Baseline and Week 52
Change From Baseline in Percentage of Nocturnal Awakening-Free Nights at Week 51-52
時間枠：Baseline up to Week 51-52
Percentage of nocturnal awakening-free nights were analyzed on a bi-weekly basis and compared to baseline scores. Data was summarized by each treatment group. In addition, data was summarized together for "EOS+ and EOS- Placebo" arms and "EOS+ and EOS- benralizumab 100 mg" arms.
Baseline up to Week 51-52
Change From Baseline in Mean Fraction Exhaled Nitric Oxide (FeNO) at Week 52
時間枠：Baseline up to Week 52
Data was summarized by each treatment group. In addition, data was summarized together for "EOS+ and EOS- Placebo" arms and "EOS+ and EOS- benralizumab 100 mg" arms.
Baseline up to Week 52

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

MedImmune LLC

協力者

MedImmune Ltd

捜査官

  • スタディディレクター：Donald Raible, MD、MedImmune LLC

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

2010年12月1日

一次修了 (実際)

2013年3月1日

研究の完了 (実際)

2013年8月1日

試験登録日

最初に提出

2010年11月9日

QC基準を満たした最初の提出物

2010年11月9日

最初の投稿 (見積もり)

2010年11月11日

学習記録の更新

投稿された最後の更新 (見積もり)

2016年11月17日

QC基準を満たした最後の更新が送信されました

2016年9月28日

最終確認日

2016年9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

  • MI-CP220
  • 2010-020126-17 (EudraCT番号)

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。

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条件

まれな病気

薬物療法

ダイエットサプリメント

スポンサー/協力者

場所

3
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