Study to Evaluate the Efficacy and Safety of MEDI9929 (AMG 157) in Adult Subjects With Inadequately Controlled, Severe Asthma
2018년 11월 5일 업데이트: 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.
연구 개요
연구 유형
중재적
등록 (실제)
584
단계
- 2 단계
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
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Durban, 남아프리카, 4068
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Middelburg, 남아프리카, 1055
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Pretoria, 남아프리카, 0181
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Pretoria, 남아프리카, 0183
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Daugavpils, 라트비아, LV-5401
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Rezekne, 라트비아, LV-4600
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Riga, 라트비아, 1001
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Riga, 라트비아, LV1002
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Riga, 라트비아, LV-1038
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Riga, 라트비아, LV1010
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Kaunas, 리투아니아, LT50009
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Klaipeda, 리투아니아, 92288
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Klaipeda, 리투아니아, 92231
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California
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Los Angeles, California, 미국, 90025
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Los Angeles, California, 미국, 90048
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Florida
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Miami, Florida, 미국, 33133
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Oviedo, Florida, 미국, 32765
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Georgia
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Savannah, Georgia, 미국, 31406
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Illinois
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Peoria, Illinois, 미국, 61602
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Maryland
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Baltimore, Maryland, 미국, 21224
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Minnesota
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Rochester, Minnesota, 미국, 55905
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New York
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New York, New York, 미국, 10016
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New York, New York, 미국, 10029
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North Carolina
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Charlotte, North Carolina, 미국, 28277
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Charlotte, North Carolina, 미국, 28207
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Ohio
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Dublin, Ohio, 미국, 43016
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Oklahoma
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Oklahoma City, Oklahoma, 미국, 73120
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South Carolina
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Rock Hill, South Carolina, 미국, 29732
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Spartanburg, South Carolina, 미국, 29303
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Texas
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Houston, Texas, 미국, 77070
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Virginia
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Richmond, Virginia, 미국, 23220
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Plovdiv, 불가리아, 4002
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Sofia, 불가리아, 1431
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Sofia, 불가리아, 1202
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Sofia, 불가리아, 1233
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Sofia, 불가리아, 1750
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Sofia, 불가리아, 1606
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Velingrad, 불가리아, 4600
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Belgrade, 세르비아, 11000
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Kragujevac, 세르비아, 34000
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Sremska Kamenica, 세르비아, 21204
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Bardejov, 슬로바키아, 085 01
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Bratislava, 슬로바키아, 84108
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Ilava, 슬로바키아, 01901
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Kosice, 슬로바키아, 040 01
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Levice, 슬로바키아, 934 01
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Nove Zamky, 슬로바키아, 940 01
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Poprad, 슬로바키아, 058 01
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Spisska Nova Ves, 슬로바키아, 052 01
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Sturovo, 슬로바키아, 94301
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Surany, 슬로바키아, 94201
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Topolcany, 슬로바키아, 95501
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Zvolen, 슬로바키아, 96001
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Dnipropetrovsk, 우크라이나, 49051
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Ivano-Frankivsk, 우크라이나, 76012
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Kyiv, 우크라이나, 04050
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Kyiv, 우크라이나, 02091
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Kyiv, 우크라이나, 03680
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Mykolayiv, 우크라이나, 54003
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Odessa, 우크라이나, 65039
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Poltava, 우크라이나, 36038
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Suprunivka Vil., Poltava Regio, 우크라이나, 36028
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Vinnytsia, 우크라이나, 21029
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Zaporizhzhya, 우크라이나, 69600
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Zaporizhzhya, 우크라이나, 69035
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Ashkelon, 이스라엘, 78278
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Haifa, 이스라엘, 34362
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Jerusalem, 이스라엘, 91120
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Kfar-Saba, 이스라엘, 44281
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Petach Tikva, 이스라엘
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Rehovot, 이스라엘, 7661041
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Tel Hashomer, 이스라엘, 52621
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Chuo-ku, 일본, 103-0028
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Chuo-ku, 일본, 103-0027
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Chuo-ku, 일본, 104-8560
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Fujisawa-shi, 일본, 251-8550
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Kiyose-shi, 일본, 204-8585
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Kurume-shi, 일본, 830-0011
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Maebashi-shi, 일본, 371-0054
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Ora-gun, 일본, 370-0615
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Sagamihara-shi, 일본, 228-0815
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Saitama-Ken, 일본, 338-8553
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Sapporo-shi, 일본, 060-0033
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Taito-ku, 일본, 111-0051
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Toshima-ku, 일본, 171-0014
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Yokkaichi-shi, 일본, 510-8567
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Brandys nad Labem, 체코, 250 01
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Hradec Kralove, 체코, 500 05
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Mlada Boleslav, 체코, 293 01
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Praha 4, 체코, 14059
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Praha 8, 체코, 180 81
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Praha 8, 체코, 180 00
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Strakonice, 체코, 38601
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Balassagyarmat, 헝가리, 2660
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Budapest, 헝가리, 1125
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Budapest, 헝가리, 1529
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Budapest, 헝가리, 1033
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Csorna, 헝가리, 9300
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Debrecen, 헝가리, 4032
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Farkasgyepü, 헝가리, 8582
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Gödöllő, 헝가리, 2100
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Komarom, 헝가리, 2900
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Mateszalka, 헝가리, 4700
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Nagykanizsa, 헝가리, 8800
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Szeged, 헝가리, H-6722
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Százhalombatta, 헝가리, 2440
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Torokbalint, 헝가리, 2045
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
18년 (성인, 고령자)
건강한 자원 봉사자를 받아들입니다
아니
연구 대상 성별
모두
설명
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.
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 더블
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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위약 비교기: 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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실험적: 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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실험적: 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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실험적: 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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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Annualized Asthma Exacerbation Rate (AER) Through Week 52
기간: 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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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Reduction in AER on Subpopulations at Week 52
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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 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
기간: 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.
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Week 0 (Day 1) through Week 52
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Number of Participants With at Least One Severe Asthma Exacerbations Through Week 52
기간: 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.
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
기간: Baseline (Week 0 [Day 1]) and Week 52
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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
기간: Baseline (Week 0 [Day 1]) and Week 52
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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
기간: Week 0 (Day 1) through Week 52
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The total amount of study drug exposure (in milligram) for the entire study period was summarized.
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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)
기간: 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
기간: 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
기간: Day 1 upto Week 64
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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
기간: From the start of study drug administration upto Week 64
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Adverse events observed in participants with clinically significant electrocardiogram abnormalities were assessed.
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From the start of study drug administration upto Week 64
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Mean Serum Concentrations of MEDI9929
기간: Week 0 (Day 1) to Week 64
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The mean serum concentrations of MEDI9929 was observed at specified timepoints.
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Week 0 (Day 1) to Week 64
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Number of Participants With Positive Antibodies to MEDI9929
기간: Week 0 (Day 1) to Week 64
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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.
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Week 0 (Day 1) to Week 64
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
스폰서
협력자
간행물 및 유용한 링크
연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.
일반 간행물
- 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.
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (실제)
2013년 12월 13일
기본 완료 (실제)
2016년 12월 12일
연구 완료 (실제)
2017년 3월 1일
연구 등록 날짜
최초 제출
2013년 12월 4일
QC 기준을 충족하는 최초 제출
2014년 2월 3일
처음 게시됨 (추정)
2014년 2월 4일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2018년 12월 4일
QC 기준을 충족하는 마지막 업데이트 제출
2018년 11월 5일
마지막으로 확인됨
2018년 11월 1일
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .