Study to Evaluate the Efficacy and Safety of MEDI9929 (AMG 157) in Adult Subjects With Inadequately Controlled, Severe Asthma
2018年11月5日 更新者：MedImmune LLC
A Phase 2 Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of MEDI9929 in Adult Subjects With Inadequately Controlled, Severe Asthma
The primary objective of the study is to evaluate the effect of 3 dose levels of MEDI9929 (AMG 157) on asthma exacerbations in adult subjects with inadequately controlled, severe asthma.
調査の概要
研究の種類
介入
入学 (実際)
584
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、90025
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Los Angeles、California、アメリカ、90048
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Florida
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Miami、Florida、アメリカ、33133
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Oviedo、Florida、アメリカ、32765
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Georgia
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Savannah、Georgia、アメリカ、31406
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Illinois
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Peoria、Illinois、アメリカ、61602
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Maryland
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Baltimore、Maryland、アメリカ、21224
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Minnesota
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Rochester、Minnesota、アメリカ、55905
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New York
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New York、New York、アメリカ、10016
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New York、New York、アメリカ、10029
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North Carolina
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Charlotte、North Carolina、アメリカ、28277
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Charlotte、North Carolina、アメリカ、28207
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Ohio
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Dublin、Ohio、アメリカ、43016
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Oklahoma
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Oklahoma City、Oklahoma、アメリカ、73120
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South Carolina
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Rock Hill、South Carolina、アメリカ、29732
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Spartanburg、South Carolina、アメリカ、29303
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Texas
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Houston、Texas、アメリカ、77070
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Virginia
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Richmond、Virginia、アメリカ、23220
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Ashkelon、イスラエル、78278
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Haifa、イスラエル、34362
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Jerusalem、イスラエル、91120
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Kfar-Saba、イスラエル、44281
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Petach Tikva、イスラエル
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Rehovot、イスラエル、7661041
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Tel Hashomer、イスラエル、52621
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Dnipropetrovsk、ウクライナ、49051
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Ivano-Frankivsk、ウクライナ、76012
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Kyiv、ウクライナ、04050
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Kyiv、ウクライナ、02091
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Kyiv、ウクライナ、03680
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Mykolayiv、ウクライナ、54003
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Odessa、ウクライナ、65039
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Poltava、ウクライナ、36038
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Suprunivka Vil., Poltava Regio、ウクライナ、36028
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Vinnytsia、ウクライナ、21029
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Zaporizhzhya、ウクライナ、69600
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Zaporizhzhya、ウクライナ、69035
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Bardejov、スロバキア、085 01
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Bratislava、スロバキア、84108
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Ilava、スロバキア、01901
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Kosice、スロバキア、040 01
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Levice、スロバキア、934 01
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Nove Zamky、スロバキア、940 01
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Poprad、スロバキア、058 01
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Spisska Nova Ves、スロバキア、052 01
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Sturovo、スロバキア、94301
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Surany、スロバキア、94201
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Topolcany、スロバキア、95501
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Zvolen、スロバキア、96001
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Belgrade、セルビア、11000
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Kragujevac、セルビア、34000
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Sremska Kamenica、セルビア、21204
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Brandys nad Labem、チェコ、250 01
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Hradec Kralove、チェコ、500 05
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Mlada Boleslav、チェコ、293 01
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Praha 4、チェコ、14059
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Praha 8、チェコ、180 81
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Praha 8、チェコ、180 00
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Strakonice、チェコ、38601
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Balassagyarmat、ハンガリー、2660
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Budapest、ハンガリー、1125
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Budapest、ハンガリー、1529
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Budapest、ハンガリー、1033
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Csorna、ハンガリー、9300
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Debrecen、ハンガリー、4032
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Farkasgyepü、ハンガリー、8582
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Gödöllő、ハンガリー、2100
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Komarom、ハンガリー、2900
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Mateszalka、ハンガリー、4700
- Research Site
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Nagykanizsa、ハンガリー、8800
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Szeged、ハンガリー、H-6722
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Százhalombatta、ハンガリー、2440
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Torokbalint、ハンガリー、2045
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Plovdiv、ブルガリア、4002
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Sofia、ブルガリア、1431
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Sofia、ブルガリア、1202
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Sofia、ブルガリア、1233
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Sofia、ブルガリア、1750
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Sofia、ブルガリア、1606
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Velingrad、ブルガリア、4600
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Daugavpils、ラトビア、LV-5401
- Research Site
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Rezekne、ラトビア、LV-4600
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Riga、ラトビア、1001
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Riga、ラトビア、LV1002
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Riga、ラトビア、LV-1038
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Riga、ラトビア、LV1010
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Kaunas、リトアニア、LT50009
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Klaipeda、リトアニア、92288
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Klaipeda、リトアニア、92231
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Durban、南アフリカ、4068
- Research Site
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Middelburg、南アフリカ、1055
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Pretoria、南アフリカ、0181
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Pretoria、南アフリカ、0183
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Chuo-ku、日本、103-0028
- Research Site
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Chuo-ku、日本、103-0027
- Research Site
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Chuo-ku、日本、104-8560
- Research Site
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Fujisawa-shi、日本、251-8550
- Research Site
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Kiyose-shi、日本、204-8585
- Research Site
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Kurume-shi、日本、830-0011
- Research Site
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Maebashi-shi、日本、371-0054
- Research Site
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Ora-gun、日本、370-0615
- Research Site
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Sagamihara-shi、日本、228-0815
- Research Site
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Saitama-Ken、日本、338-8553
- Research Site
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Sapporo-shi、日本、060-0033
- Research Site
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Taito-ku、日本、111-0051
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Toshima-ku、日本、171-0014
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Yokkaichi-shi、日本、510-8567
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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～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
- Body mass index (BMI) between 18-40 kg/m2 and weight greater than or equal 40 kg
- Documented physician-diagnosed asthma - Subjects must have received a physician-prescribed asthma controller regimen with medium- or high-dose inhaled corticosteroids (ICS) plus long acting β2 agonist (LABA) -If on asthma controller medications in addition to ICS plus LABA, the dose of the other asthma controller medications (leukotriene receptor inhibitors, theophylline, secondary ICS, long-acting anti-muscarinics (LAMA), cromones, or maintenance oral prednisone or equivalent up to a maximum of 10 mg daily or 20 mg every other day for the maintenance treatment of asthma) must be stable. -Subjects must have a documented history of at least 2 asthma exacerbation events OR at least 1 severe asthma exacerbation resulting in hospitalization within the 12 months prior to first study visit.
Exclusion Criteria:
- Diagnosis of vocal cord dysfunction, reactive airways dysfunction syndrome, hyperventilation and panic attacks, or other mimics of asthma.
- Current smokers or subjects with a smoking history of ≥ 10 pack years
- Former smokers with < 10 pack years must have stopped for at least 1 year to be eligible.
- Any concomitant respiratory disease that in the opinion of the investigator and/or medical monitor will interfere with the evaluation of the investigational product or interpretation of subject safety or study results (eg, chronic obstructive pulmonary disease, cystic fibrosis, pulmonary fibrosis, bronchiectasis, allergic bronchopulmonary aspergillosis, Churg-Strauss syndrome).
- Evidence of active liver disease.
- History of Cancer, except for basal cell carcinoma or insitu carcinoma of the cervix treated with apparent success with curative therapy or other malignancies are eligible provided that curative therapy was completed -Known history of active tuberculosis (TB)
- History of anaphylaxis to any biologic therapy
- Positive medical history for hepatitis B or C
- Subject with human immunodeficiency virus (HIV) or subject taking antiretroviral medications, as determined by medical history and/or subject's verbal report.
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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プラセボコンパレーター：Placebo
Participants received placebo matched to MEDI9929 subcutaneously once every 2 weeks from Day 1 to Week 50.
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Participants received placebo matched to MEDI9929 subcutaneously once every 2 weeks from Day 1 to Week 50.
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実験的：MEDI9929 70 mg
Participants received 70 milligram (mg) of MEDI9929 subcutaneously once every 4 weeks from Day 1 to Week 48 along with subcutaneous placebo once every 4 weeks from Week 2 to Week 50.
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Participants received 70 milligram (mg) of MEDI9929 subcutaneously once every 4 weeks from Day 1 to Week 48 along with subcutaneous placebo once every 4 weeks from Week 2 to Week 50.
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実験的：MEDI9929 210 mg
Participants received 210 mg of MEDI9929 subcutaneously once every 4 weeks from Day 1 to Week 48 along with subcutaneous placebo once every 4 weeks from Week 2 to Week 50.
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Participants received 210 mg of MEDI9929 subcutaneously once every 4 weeks from Day 1 to Week 48 along with subcutaneous placebo once every 4 weeks from Week 2 to Week 50.
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実験的：MEDI9929 280 mg
Participants received 280 mg of MEDI9929 subcutaneously once every 2 weeks from Day 1 to Week 50.
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Participants received 280 mg of MEDI9929 subcutaneously once every 2 weeks from Day 1 to Week 50.
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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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Annualized Asthma Exacerbation Rate (AER) Through Week 52
時間枠：Week 0 (Day 1) up to Week 52
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Asthma exacerbation is defined as worsening of asthma that leads to any of the following: use of systemic corticosteroids for at least 3 days, an emergency department visit due to asthma that required systemic corticosteroids, and an inpatient hospitalization due to asthma.
The annual AER was presented as the total number of exacerbations for the treatment group divided by the total duration of person follow-up.
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Week 0 (Day 1) up to Week 52
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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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Reduction in AER on Subpopulations at Week 52
時間枠：Week 52
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Asthma exacerbation is defined as worsening of asthma that leads to any of the following: use of systemic corticosteroids for at least 3 days, an emergency department visit due to asthma that required systemic corticosteroids, and an inpatient hospitalization due to asthma.
Reduction in AER was evaluated in pre-specified subpopulations (blood eosinophil count [eosinophilic and non-eosinophilic], T helper cell 2 [Th2] status [high and low], Fraction of exhaled nitric oxide [FENO] [high and low], serum periostin [high and low], current post bronchodilator forced expiratory volume in 1 second [Post-BD FEV1] reversibility- yes, allergic and non-allergic) of asthma.
The annual AER was presented as the total number of exacerbations for the treatment group divided by the total duration of person follow-up.
Also, the high or low was determined using median value.
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Week 52
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Change From Baseline in Pre-bronchodilator (Pre-BD) Forced Expiratory Volume in 1 Second (FEV1) and Forced Vital Capacity (FVC) at Week 52
時間枠：Baseline (Week 0 [Day 1]) to Week 52
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Forced expiratory volume in 1 second and forced vital capacity measures taken before bronchodilator use were reported.
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Baseline (Week 0 [Day 1]) to Week 52
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Change From Baseline in FEV1 on Subpopulations at Week 52
時間枠：Baseline and up to Week 52
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Forced expiratory volume in one second (FEV1) was evaluated in pre-specified subpopulations of asthma.
The data presented in the below table for this outcome measure is for pre-bronchodilator FEV1.
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Baseline and up to Week 52
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Change From Baseline in Post-bronchodilator (Post-BD) FEV1 and FVC at Week 52
時間枠：Baseline (Week 0 [Day 1]) to Week 52
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Forced expiratory volume in 1 second and forced vital capacity measures taken after bronchodilator use were reported.
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Baseline (Week 0 [Day 1]) to Week 52
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Change From Baseline in Overall Symptoms Score on Subpopulations at Week 52
時間枠：Baseline and up to Week 52
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Asthma symptoms during night time and daytime are recorded by the participant in the asthma daily diary.
Overall symptom score is the average of scores of daytime severity, daytime frequency, and nighttime severity symptoms.
The daytime frequency and severity items are scored from 0 to 4, where a higher score indicates greater frequency/severity and nighttime severity item is scored from 0 to 4 , where a higher score indicates greater severity.
Overall symptom score ranges from 0 to 4, where lower score indicates better asthma symptom while, higher score indicates worse asthma symptom.
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Baseline and up to Week 52
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Change From Baseline in Asthma Symptoms Measured by Asthma Daily Diary at Week 52
時間枠：Baseline (Week 0 [Day 1]) and Week 52
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Asthma symptoms during night time and daytime are recorded by the participant in the asthma daily diary.
Symptom score values for night time assessment is 0 (no asthma symptom) to 3 (unable to sleep because of asthma) and symptom score values for day time assessment is 0 (no asthma symptom) to 3 (unable to do normal activities due to asthma).
Total asthma symptom score is the sum of the daytime and night time score (0 to 6).
Lower score (0) is indicating better asthma symptom, while higher score (6) is indicating worse asthma symptom.
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Baseline (Week 0 [Day 1]) and Week 52
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Change From Baseline in Asthma Symptoms Measured by Asthma Control Questionnaire (ACQ-6) Score at Week 52
時間枠：Baseline (Week 0 [Day 1]) and Week 52
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The ACQ is a patient-reported questionnaire assessing asthma symptoms (ie, night-time waking, symptoms on waking, activity limitation, shortness of breath, wheezing) and daily rescue bronchodilator use and FEV1.
The ACQ-6 is a shortened version of the ACQ that omits the FEV1 measurement from the original ACQ score.
Questions are weighted equally and scored from 0 (totally controlled) to 6 (severely uncontrolled).
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Baseline (Week 0 [Day 1]) and Week 52
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Rate of Severe Asthma Exacerbation Through Week 52
時間枠：Week 0 (Day 1) up to Week 52
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A severe asthma exacerbation is defined as an event that resulted in hospitalization.
The severe AER was presented as the total number of exacerbations for the treatment group divided by the total duration of person follow-up.
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Week 0 (Day 1) up to Week 52
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Time to First Asthma Exacerbation Through Week 52
時間枠：Week 0 (Day 1) through Week 52
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Asthma exacerbation is defined as worsening of asthma that leads to use of systemic corticosteroids for at least 3 days, an emergency department visit due to asthma that required systemic corticosteroids, and an inpatient hospitalization due to asthma.
Time to first asthma exacerbation was reported.
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Week 0 (Day 1) through Week 52
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Time to First Severe Asthma Exacerbation Through Week 52
時間枠：Week 0 (Day 1) through Week 52
|
Asthma exacerbation is defined as worsening of asthma that leads to use of systemic corticosteroids for at least 3 days, an emergency department visit due to asthma that required systemic corticosteroids, and an inpatient hospitalization due to asthma.
Time to first severe asthma exacerbations (hospitalization) were reported.
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Week 0 (Day 1) through Week 52
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Number of Participants With at Least One Asthma Exacerbations Through Week 52
時間枠：Week 0 (Day 1) through Week 52
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Asthma exacerbation is defined as worsening of asthma that leads to use of systemic corticosteroids for at least 3 days, an emergency department visit due to asthma that required systemic corticosteroids, and an inpatient hospitalization due to asthma.
|
Week 0 (Day 1) through Week 52
|
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Number of Participants With at Least One Severe Asthma Exacerbations Through Week 52
時間枠：Week 0 (Day 1) through Week 52
|
Asthma exacerbation is defined as worsening of asthma that leads to use of systemic corticosteroids for at least 3 days, an emergency department visit due to asthma that required systemic corticosteroids, and an inpatient hospitalization due to asthma.
Participants with severe asthma exacerbations (hospitalization) were reported.
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Week 0 (Day 1) through Week 52
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Change From Baseline in Asthma Quality of Life Questionnaire (Standardized Version) (AQLQ [S]) Overall Score at Week 52
時間枠：Baseline (Week 0 [Day 1]) and Week 52
|
The AQLQ(S) +12 is a 32-item questionnaire that measures the health-related quality of life experienced by asthma participants.
The questionnaire comprises 4 separate domains (symptoms, activity limitations, emotional function, and environmental stimuli) scaled on a 7-point scale ranging from 7 (no impairment) to 1 (severe impairment).
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Baseline (Week 0 [Day 1]) and Week 52
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Change From Baseline in European Quality of Life-5 Dimensions 5 Level Version (EQ-5D-5L) Health State Evaluation at Week 52
時間枠：Baseline (Week 0 [Day 1]) and Week 52
|
European Quality of Life-5 Dimensions-5 Level (EQ-5D-5L) is a standardized measure of health status of the participant.
The first component is a descriptive system of the respondent's health comprised of the following 5 participant-reported dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression.
Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems, and extreme problems.
The responses are used to derive the health state index scores using the United Kingdom (UK) algorithm, with scores ranging from -0.594 to 1.
A higher score indicates better health state.
The second component is a self-perceived health score which is assessed using a visual analogue scale (VAS) that ranged from 0 to 100, where 0 indicated the worst health you can imagine and 100 indicated the best health you can imagine.
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Baseline (Week 0 [Day 1]) and Week 52
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Total Amount of Study Drug Exposure
時間枠：Week 0 (Day 1) through Week 52
|
The total amount of study drug exposure (in milligram) for the entire study period was summarized.
|
Week 0 (Day 1) through Week 52
|
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Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs)
時間枠：Day 1 upto Week 64
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An adverse event is any unfavourable and unintended signs (including abnormal laboratory findings), symptoms, or diseases temporally associated with use of medicinal product, whether or not considered related to medicinal product.
Serious adverse event is any adverse event that resulted in death, life-threatening, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, is a congenital anomaly/birth defect in offspring of a study participant, is an important medical event that may jeopardize the participant or may require medical intervention.
TEAEs are defined as events present at baseline that worsened in intensity after administration of study drug or events absent at baseline that emerged after administration of study drug, for the period until and including the follow-up period (Week 64).
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Day 1 upto Week 64
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Number of Participants With TEAEs Related to Vital Sign Parameters
時間枠：Day 1 upto Week 64
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Adverse events observed in participants with clinically significant vital signs abnormalities were assessed.
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Day 1 upto Week 64
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Number of Participants With TEAEs Related to Clinical Laboratory Evaluation
時間枠：Day 1 upto Week 64
|
An abnormal laboratory finding which required an action or intervention by the investigator, or a finding judged by the investigator to represent a change beyond the range of normal physiologic fluctuation were reported as an adverse event.
Laboratory evaluations of blood and urine samples were performed.
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Day 1 upto Week 64
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Number of Participants With TEAEs Related to Electrocardiogram Evaluations
時間枠：From the start of study drug administration upto Week 64
|
Adverse events observed in participants with clinically significant electrocardiogram abnormalities were assessed.
|
From the start of study drug administration upto Week 64
|
|
Mean Serum Concentrations of MEDI9929
時間枠：Week 0 (Day 1) to Week 64
|
The mean serum concentrations of MEDI9929 was observed at specified timepoints.
|
Week 0 (Day 1) to Week 64
|
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Number of Participants With Positive Antibodies to MEDI9929
時間枠：Week 0 (Day 1) to Week 64
|
Blood samples for immunogenicity assessment included the determination of anti-drug antibodies (ADA) for MEDI9929.
The number of participants with positive serum antibodies to MEDI9929 were presented.
|
Week 0 (Day 1) to Week 64
|
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
協力者
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
- Corren J, Parnes JR, Wang L, Mo M, Roseti SL, Griffiths JM, van der Merwe R. Tezepelumab in Adults with Uncontrolled Asthma. N Engl J Med. 2017 Sep 7;377(10):936-946. doi: 10.1056/NEJMoa1704064. Erratum In: N Engl J Med. 2019 May 23;380(21):2082.
- Corren J, Pham TH, Garcia Gil E, Salapa K, Ren P, Parnes JR, Colice G, Griffiths JM. Baseline type 2 biomarker levels and response to tezepelumab in severe asthma. Allergy. 2022 Jun;77(6):1786-1796. doi: 10.1111/all.15197. Epub 2022 Feb 9.
- Corren J, Ambrose CS, Salapa K, Roseti SL, Griffiths JM, Parnes JR, Colice G. Efficacy of Tezepelumab in Patients with Severe, Uncontrolled Asthma and Perennial Allergy. J Allergy Clin Immunol Pract. 2021 Dec;9(12):4334-4342.e6. doi: 10.1016/j.jaip.2021.07.045. Epub 2021 Aug 3.
- Ly N, Zheng Y, Griffiths JM, van der Merwe R, Agoram B, Parnes JR, Roskos L. Pharmacokinetic and Pharmacodynamic Modeling of Tezepelumab to Guide Phase 3 Dose Selection for Patients With Severe Asthma. J Clin Pharmacol. 2021 Jul;61(7):901-912. doi: 10.1002/jcph.1803. Epub 2021 Jan 16.
- Corren J, Garcia Gil E, Griffiths JM, Parnes JR, van der Merwe R, Salapa K, O'Quinn S. Tezepelumab improves patient-reported outcomes in patients with severe, uncontrolled asthma in PATHWAY. Ann Allergy Asthma Immunol. 2021 Feb;126(2):187-193. doi: 10.1016/j.anai.2020.10.008. Epub 2020 Oct 23.
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)
2013年12月13日
一次修了 (実際)
2016年12月12日
研究の完了 (実際)
2017年3月1日
試験登録日
最初に提出
2013年12月4日
QC基準を満たした最初の提出物
2014年2月3日
最初の投稿 (見積もり)
2014年2月4日
学習記録の更新
投稿された最後の更新 (実際)
2018年12月4日
QC基準を満たした最後の更新が送信されました
2018年11月5日
最終確認日
2018年11月1日
詳しくは
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。