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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02054130
Other study ID # CD-RI-MEDI9929-1146
Secondary ID 2013-003269-33
Status Completed
Phase Phase 2
First received
Last updated
Start date December 13, 2013
Est. completion date March 1, 2017

Study information

Verified date November 2018
Source MedImmune LLC
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Completed
Enrollment 584
Est. completion date March 1, 2017
Est. primary completion date December 12, 2016
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility 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 ß2 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.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Placebo
Participants received placebo matched to MEDI9929 subcutaneously once every 2 weeks from Day 1 to Week 50.
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.
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.
MEDI9929 280 mg
Participants received 280 mg of MEDI9929 subcutaneously once every 2 weeks from Day 1 to Week 50.

Locations

Country Name City State
Bulgaria Research Site Plovdiv
Bulgaria Research Site Sofia
Bulgaria Research Site Sofia
Bulgaria Research Site Sofia
Bulgaria Research Site Sofia
Bulgaria Research Site Sofia
Bulgaria Research Site Velingrad
Czechia Research Site Brandys nad Labem
Czechia Research Site Hradec Kralove
Czechia Research Site Mlada Boleslav
Czechia Research Site Praha 4
Czechia Research Site Praha 8
Czechia Research Site Praha 8
Czechia Research Site Strakonice
Hungary Research Site Balassagyarmat
Hungary Research Site Budapest
Hungary Research Site Budapest
Hungary Research Site Budapest
Hungary Research Site Csorna
Hungary Research Site Debrecen
Hungary Research Site Farkasgyepü
Hungary Research Site Gödöllo
Hungary Research Site Komarom
Hungary Research Site Mateszalka
Hungary Research Site Nagykanizsa
Hungary Research Site Százhalombatta
Hungary Research Site Szeged
Hungary Research Site Torokbalint
Israel Research Site Ashkelon
Israel Research Site Haifa
Israel Research Site Jerusalem
Israel Research Site Kfar-Saba
Israel Research Site Petach Tikva
Israel Research Site Rehovot
Israel Research Site Tel Hashomer
Japan Research Site Chuo-ku
Japan Research Site Chuo-ku
Japan Research Site Chuo-ku
Japan Research Site Fujisawa-shi
Japan Research Site Kiyose-shi
Japan Research Site Kurume-shi
Japan Research Site Maebashi-shi
Japan Research Site Ora-gun
Japan Research Site Sagamihara-shi
Japan Research Site Saitama-Ken
Japan Research Site Sapporo-shi
Japan Research Site Taito-ku
Japan Research Site Toshima-ku
Japan Research Site Yokkaichi-shi
Latvia Research Site Daugavpils
Latvia Research Site Rezekne
Latvia Research Site Riga
Latvia Research Site Riga
Latvia Research Site Riga
Latvia Research Site Riga
Lithuania Research Site Kaunas
Lithuania Research Site Klaipeda
Lithuania Research Site Klaipeda
Serbia Research Site Belgrade
Serbia Research Site Kragujevac
Serbia Research Site Sremska Kamenica
Slovakia Research Site Bardejov
Slovakia Research Site Bratislava
Slovakia Research Site Ilava
Slovakia Research Site Kosice
Slovakia Research Site Levice
Slovakia Research Site Nove Zamky
Slovakia Research Site Poprad
Slovakia Research Site Spisska Nova Ves
Slovakia Research Site Sturovo
Slovakia Research Site Surany
Slovakia Research Site Topolcany
Slovakia Research Site Zvolen
South Africa Research Site Durban
South Africa Research Site Middelburg
South Africa Research Site Pretoria
South Africa Research Site Pretoria
Ukraine Research Site Dnipropetrovsk
Ukraine Research Site Ivano-Frankivsk
Ukraine Research Site Kyiv
Ukraine Research Site Kyiv
Ukraine Research Site Kyiv
Ukraine Research Site Mykolayiv
Ukraine Research Site Odessa
Ukraine Research Site Poltava
Ukraine Research Site Suprunivka Vil., Poltava Regio
Ukraine Research Site Vinnytsia
Ukraine Research Site Zaporizhzhya
Ukraine Research Site Zaporizhzhya
United States Research Site Baltimore Maryland
United States Research Site Charlotte North Carolina
United States Research Site Charlotte North Carolina
United States Research Site Dublin Ohio
United States Research Site Houston Texas
United States Research Site Los Angeles California
United States Research Site Los Angeles California
United States Research Site Miami Florida
United States Research Site New York New York
United States Research Site New York New York
United States Research Site Oklahoma City Oklahoma
United States Research Site Oviedo Florida
United States Research Site Peoria Illinois
United States Research Site Richmond Virginia
United States Research Site Rochester Minnesota
United States Research Site Rock Hill South Carolina
United States Research Site Savannah Georgia
United States Research Site Spartanburg South Carolina

Sponsors (2)

Lead Sponsor Collaborator
MedImmune LLC Amgen

Countries where clinical trial is conducted

United States,  Bulgaria,  Czechia,  Hungary,  Israel,  Japan,  Latvia,  Lithuania,  Serbia,  Slovakia,  South Africa,  Ukraine, 

References & Publications (1)

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Annualized Asthma Exacerbation Rate (AER) Through Week 52 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. Week 0 (Day 1) up to Week 52
Secondary Reduction in AER on Subpopulations at Week 52 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. Week 52
Secondary Change From Baseline in Pre-bronchodilator (Pre-BD) Forced Expiratory Volume in 1 Second (FEV1) and Forced Vital Capacity (FVC) at Week 52 Forced expiratory volume in 1 second and forced vital capacity measures taken before bronchodilator use were reported. Baseline (Week 0 [Day 1]) to Week 52
Secondary Change From Baseline in FEV1 on Subpopulations at Week 52 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. Baseline and up to Week 52
Secondary Change From Baseline in Post-bronchodilator (Post-BD) FEV1 and FVC at Week 52 Forced expiratory volume in 1 second and forced vital capacity measures taken after bronchodilator use were reported. Baseline (Week 0 [Day 1]) to Week 52
Secondary Change From Baseline in Overall Symptoms Score on Subpopulations at Week 52 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. Baseline and up to Week 52
Secondary Change From Baseline in Asthma Symptoms Measured by Asthma Daily Diary at Week 52 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. Baseline (Week 0 [Day 1]) and Week 52
Secondary Change From Baseline in Asthma Symptoms Measured by Asthma Control Questionnaire (ACQ-6) Score at Week 52 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). Baseline (Week 0 [Day 1]) and Week 52
Secondary Rate of Severe Asthma Exacerbation Through Week 52 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. Week 0 (Day 1) up to Week 52
Secondary Time to First Asthma Exacerbation 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 asthma exacerbation was reported. Week 0 (Day 1) through Week 52
Secondary Time to First Severe Asthma Exacerbation 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. Week 0 (Day 1) through Week 52
Secondary Number of Participants With at Least One Asthma Exacerbations 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. Week 0 (Day 1) through Week 52
Secondary Number of Participants With at Least One Severe Asthma Exacerbations 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. Week 0 (Day 1) through Week 52
Secondary Change From Baseline in Asthma Quality of Life Questionnaire (Standardized Version) (AQLQ [S]) Overall Score at 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). Baseline (Week 0 [Day 1]) and Week 52
Secondary Change From Baseline in European Quality of Life-5 Dimensions 5 Level Version (EQ-5D-5L) Health State Evaluation at 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. Baseline (Week 0 [Day 1]) and Week 52
Secondary Total Amount of Study Drug Exposure The total amount of study drug exposure (in milligram) for the entire study period was summarized. Week 0 (Day 1) through Week 52
Secondary Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs) 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). Day 1 upto Week 64
Secondary Number of Participants With TEAEs Related to Vital Sign Parameters Adverse events observed in participants with clinically significant vital signs abnormalities were assessed. Day 1 upto Week 64
Secondary Number of Participants With TEAEs Related to Clinical Laboratory Evaluation 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. Day 1 upto Week 64
Secondary Number of Participants With TEAEs Related to Electrocardiogram Evaluations Adverse events observed in participants with clinically significant electrocardiogram abnormalities were assessed. From the start of study drug administration upto Week 64
Secondary Mean Serum Concentrations of MEDI9929 The mean serum concentrations of MEDI9929 was observed at specified timepoints. Week 0 (Day 1) to Week 64
Secondary Number of Participants With Positive Antibodies to MEDI9929 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
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