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Study to Evaluate the Efficacy and Safety of MEDI9929 (AMG 157) in Adult Subjects With Inadequately Controlled, Severe Asthma

Primary Purpose

Asthma

Status

Completed

Phase

Phase 2

Locations

International

Study Type

Interventional

Intervention

Placebo

MEDI9929 70 mg

MEDI9929 210 mg

MEDI9929 280 mg

About this trial

This is an interventional treatment trial for Asthma focused on measuring Asthma

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Placebo Comparator

Experimental

Arm Label

Placebo

MEDI9929 70 mg

MEDI9929 210 mg

MEDI9929 280 mg

Arm Description

Participants received placebo matched to MEDI9929 subcutaneously once every 2 weeks from Day 1 to Week 50.

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.

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.

Participants received 280 mg of MEDI9929 subcutaneously once every 2 weeks from Day 1 to Week 50.

Outcomes

Primary Outcome Measures

Annualized Asthma Exacerbation Rate (AER) Through Week 52

Secondary Outcome Measures

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.

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.

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.

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.

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.

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.

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).

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.

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.

Time to First Severe Asthma Exacerbation Through Week 52

Number of Participants With at Least One Asthma Exacerbations Through Week 52

Number of Participants With at Least One Severe Asthma Exacerbations Through Week 52

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).

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.

Total Amount of Study Drug Exposure

The total amount of study drug exposure (in milligram) for the entire study period was summarized.

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).

Number of Participants With TEAEs Related to Vital Sign Parameters

Adverse events observed in participants with clinically significant vital signs abnormalities were assessed.

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.

Number of Participants With TEAEs Related to Electrocardiogram Evaluations

Adverse events observed in participants with clinically significant electrocardiogram abnormalities were assessed.

Mean Serum Concentrations of MEDI9929

The mean serum concentrations of MEDI9929 was observed at specified timepoints.

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.

Full Information

NCT ID

NCT02054130

First Posted

December 4, 2013

Last Updated

November 5, 2018

Sponsor

MedImmune LLC

Collaborators

Amgen

1. Study Identification

Unique Protocol Identification Number

NCT02054130

Brief Title

Study to Evaluate the Efficacy and Safety of MEDI9929 (AMG 157) in Adult Subjects With Inadequately Controlled, Severe Asthma

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

November 2018

Overall Recruitment Status

Completed

Study Start Date

December 13, 2013 (Actual)

Primary Completion Date

December 12, 2016 (Actual)

Study Completion Date

March 1, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

MedImmune LLC

Collaborators

Amgen

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Asthma

Keywords

Asthma

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

584 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Participants received placebo matched to MEDI9929 subcutaneously once every 2 weeks from Day 1 to Week 50.

Arm Title

MEDI9929 70 mg

Arm Type

Experimental

Arm Description

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.

Arm Title

MEDI9929 210 mg

Arm Type

Experimental

Arm Description

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.

Arm Title

MEDI9929 280 mg

Arm Type

Experimental

Arm Description

Participants received 280 mg of MEDI9929 subcutaneously once every 2 weeks from Day 1 to Week 50.

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Participants received placebo matched to MEDI9929 subcutaneously once every 2 weeks from Day 1 to Week 50.

Intervention Type

Drug

Intervention Name(s)

MEDI9929 70 mg

Intervention Description

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.

Intervention Type

Drug

Intervention Name(s)

MEDI9929 210 mg

Intervention Description

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.

Intervention Type

Drug

Intervention Name(s)

MEDI9929 280 mg

Intervention Description

Participants received 280 mg of MEDI9929 subcutaneously once every 2 weeks from Day 1 to Week 50.

Primary Outcome Measure Information:

Title

Annualized Asthma Exacerbation Rate (AER) Through Week 52

Description

Time Frame

Week 0 (Day 1) up to Week 52

Secondary Outcome Measure Information:

Title

Reduction in AER on Subpopulations at Week 52

Description

Time Frame

Week 52

Title

Change From Baseline in Pre-bronchodilator (Pre-BD) Forced Expiratory Volume in 1 Second (FEV1) and Forced Vital Capacity (FVC) at Week 52

Description

Forced expiratory volume in 1 second and forced vital capacity measures taken before bronchodilator use were reported.

Time Frame

Baseline (Week 0 [Day 1]) to Week 52

Title

Change From Baseline in FEV1 on Subpopulations at Week 52

Description

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.

Time Frame

Baseline and up to Week 52

Title

Change From Baseline in Post-bronchodilator (Post-BD) FEV1 and FVC at Week 52

Description

Forced expiratory volume in 1 second and forced vital capacity measures taken after bronchodilator use were reported.

Time Frame

Baseline (Week 0 [Day 1]) to Week 52

Title

Change From Baseline in Overall Symptoms Score on Subpopulations at Week 52

Description

Time Frame

Baseline and up to Week 52

Title

Change From Baseline in Asthma Symptoms Measured by Asthma Daily Diary at Week 52

Description

Time Frame

Baseline (Week 0 [Day 1]) and Week 52

Title

Change From Baseline in Asthma Symptoms Measured by Asthma Control Questionnaire (ACQ-6) Score at Week 52

Description

Time Frame

Baseline (Week 0 [Day 1]) and Week 52

Title

Rate of Severe Asthma Exacerbation Through Week 52

Description

Time Frame

Week 0 (Day 1) up to Week 52

Title

Time to First Asthma Exacerbation Through Week 52

Description

Time Frame

Week 0 (Day 1) through Week 52

Title

Time to First Severe Asthma Exacerbation Through Week 52

Description

Time Frame

Week 0 (Day 1) through Week 52

Title

Number of Participants With at Least One Asthma Exacerbations Through Week 52

Description

Time Frame

Week 0 (Day 1) through Week 52

Title

Number of Participants With at Least One Severe Asthma Exacerbations Through Week 52

Description

Time Frame

Week 0 (Day 1) through Week 52

Title

Change From Baseline in Asthma Quality of Life Questionnaire (Standardized Version) (AQLQ [S]) Overall Score at Week 52

Description

Time Frame

Baseline (Week 0 [Day 1]) and Week 52

Title

Change From Baseline in European Quality of Life-5 Dimensions 5 Level Version (EQ-5D-5L) Health State Evaluation at Week 52

Description

Time Frame

Baseline (Week 0 [Day 1]) and Week 52

Title

Total Amount of Study Drug Exposure

Description

The total amount of study drug exposure (in milligram) for the entire study period was summarized.

Time Frame

Week 0 (Day 1) through Week 52

Title

Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs)

Description

Time Frame

Day 1 upto Week 64

Title

Number of Participants With TEAEs Related to Vital Sign Parameters

Description

Adverse events observed in participants with clinically significant vital signs abnormalities were assessed.

Time Frame

Day 1 upto Week 64

Title

Number of Participants With TEAEs Related to Clinical Laboratory Evaluation

Description

Time Frame

Day 1 upto Week 64

Title

Number of Participants With TEAEs Related to Electrocardiogram Evaluations

Description

Adverse events observed in participants with clinically significant electrocardiogram abnormalities were assessed.

Time Frame

From the start of study drug administration upto Week 64

Title

Mean Serum Concentrations of MEDI9929

Description

The mean serum concentrations of MEDI9929 was observed at specified timepoints.

Time Frame

Week 0 (Day 1) to Week 64

Title

Number of Participants With Positive Antibodies to MEDI9929

Description

Time Frame

Week 0 (Day 1) to Week 64

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

MedImmune LLC

Organizational Affiliation

MedImmune LLC

Official's Role

Study Director

Facility Information:

Facility Name

Research Site

City

Los Angeles

State/Province

California

ZIP/Postal Code

90025

Country

United States

Facility Name

Research Site

City

Los Angeles

State/Province

California

ZIP/Postal Code

90048

Country

United States

Facility Name

Research Site

City

Miami

State/Province

Florida

ZIP/Postal Code

33133

Country

United States

Facility Name

Research Site

City

Oviedo

State/Province

Florida

ZIP/Postal Code

32765

Country

United States

Facility Name

Research Site

City

Savannah

State/Province

Georgia

ZIP/Postal Code

31406

Country

United States

Facility Name

Research Site

City

Peoria

State/Province

Illinois

ZIP/Postal Code

61602

Country

United States

Facility Name

Research Site

City

Baltimore

State/Province

Maryland

ZIP/Postal Code

21224

Country

United States

Facility Name

Research Site

City

Rochester

State/Province

Minnesota

ZIP/Postal Code

55905

Country

United States

Facility Name

Research Site

City

New York

State/Province

New York

ZIP/Postal Code

10016

Country

United States

Facility Name

Research Site

City

New York

State/Province

New York

ZIP/Postal Code

10029

Country

United States

Facility Name

Research Site

City

Charlotte

State/Province

North Carolina

ZIP/Postal Code

28207

Country

United States

Facility Name

Research Site

City

Charlotte

State/Province

North Carolina

ZIP/Postal Code

28277

Country

United States

Facility Name

Research Site

City

Dublin

State/Province

Ohio

ZIP/Postal Code

43016

Country

United States

Facility Name

Research Site

City

Oklahoma City

State/Province

Oklahoma

ZIP/Postal Code

73120

Country

United States

Facility Name

Research Site

City

Rock Hill

State/Province

South Carolina

ZIP/Postal Code

29732

Country

United States

Facility Name

Research Site

City

Spartanburg

State/Province

South Carolina

ZIP/Postal Code

29303

Country

United States

Facility Name

Research Site

City

Houston

State/Province

Texas

ZIP/Postal Code

77070

Country

United States

Facility Name

Research Site

City

Richmond

State/Province

Virginia

ZIP/Postal Code

23220

Country

United States

Facility Name

Research Site

City

Plovdiv

ZIP/Postal Code

4002

Country

Bulgaria

Facility Name

Research Site

City

Sofia

ZIP/Postal Code

1202

Country

Bulgaria

Facility Name

Research Site

City

Sofia

ZIP/Postal Code

1233

Country

Bulgaria

Facility Name

Research Site

City

Sofia

ZIP/Postal Code

1431

Country

Bulgaria

Facility Name

Research Site

City

Sofia

ZIP/Postal Code

1606

Country

Bulgaria

Facility Name

Research Site

City

Sofia

ZIP/Postal Code

1750

Country

Bulgaria

Facility Name

Research Site

City

Velingrad

ZIP/Postal Code

4600

Country

Bulgaria

Facility Name

Research Site

City

Brandys nad Labem

ZIP/Postal Code

250 01

Country

Czechia

Facility Name

Research Site

City

Hradec Kralove

ZIP/Postal Code

500 05

Country

Czechia

Facility Name

Research Site

City

Mlada Boleslav

ZIP/Postal Code

293 01

Country

Czechia

Facility Name

Research Site

City

Praha 4

ZIP/Postal Code

14059

Country

Czechia

Facility Name

Research Site

City

Praha 8

ZIP/Postal Code

180 00

Country

Czechia

Facility Name

Research Site

City

Praha 8

ZIP/Postal Code

180 81

Country

Czechia

Facility Name

Research Site

City

Strakonice

ZIP/Postal Code

38601

Country

Czechia

Facility Name

Research Site

City

Balassagyarmat

ZIP/Postal Code

2660

Country

Hungary

Facility Name

Research Site

City

Budapest

ZIP/Postal Code

1033

Country

Hungary

Facility Name

Research Site

City

Budapest

ZIP/Postal Code

1125

Country

Hungary

Facility Name

Research Site

City

Budapest

ZIP/Postal Code

1529

Country

Hungary

Facility Name

Research Site

City

Csorna

ZIP/Postal Code

9300

Country

Hungary

Facility Name

Research Site

City

Debrecen

ZIP/Postal Code

4032

Country

Hungary

Facility Name

Research Site

City

Farkasgyepü

ZIP/Postal Code

8582

Country

Hungary

Facility Name

Research Site

City

Gödöllő

ZIP/Postal Code

2100

Country

Hungary

Facility Name

Research Site

City

Komarom

ZIP/Postal Code

2900

Country

Hungary

Facility Name

Research Site

City

Mateszalka

ZIP/Postal Code

4700

Country

Hungary

Facility Name

Research Site

City

Nagykanizsa

ZIP/Postal Code

8800

Country

Hungary

Facility Name

Research Site

City

Szeged

ZIP/Postal Code

H-6722

Country

Hungary

Facility Name

Research Site

City

Százhalombatta

ZIP/Postal Code

2440

Country

Hungary

Facility Name

Research Site

City

Torokbalint

ZIP/Postal Code

2045

Country

Hungary

Facility Name

Research Site

City

Ashkelon

ZIP/Postal Code

78278

Country

Israel

Facility Name

Research Site

City

Haifa

ZIP/Postal Code

34362

Country

Israel

Facility Name

Research Site

City

Jerusalem

ZIP/Postal Code

91120

Country

Israel

Facility Name

Research Site

City

Kfar-Saba

ZIP/Postal Code

44281

Country

Israel

Facility Name

Research Site

City

Petach Tikva

Country

Israel

Facility Name

Research Site

City

Rehovot

ZIP/Postal Code

7661041

Country

Israel

Facility Name

Research Site

City

Tel Hashomer

ZIP/Postal Code

52621

Country

Israel

Facility Name

Research Site

City

Chuo-ku

ZIP/Postal Code

103-0027

Country

Japan

Facility Name

Research Site

City

Chuo-ku

ZIP/Postal Code

103-0028

Country

Japan

Facility Name

Research Site

City

Chuo-ku

ZIP/Postal Code

104-8560

Country

Japan

Facility Name

Research Site

City

Fujisawa-shi

ZIP/Postal Code

251-8550

Country

Japan

Facility Name

Research Site

City

Kiyose-shi

ZIP/Postal Code

204-8585

Country

Japan

Facility Name

Research Site

City

Kurume-shi

ZIP/Postal Code

830-0011

Country

Japan

Facility Name

Research Site

City

Maebashi-shi

ZIP/Postal Code

371-0054

Country

Japan

Facility Name

Research Site

City

Ora-gun

ZIP/Postal Code

370-0615

Country

Japan

Facility Name

Research Site

City

Sagamihara-shi

ZIP/Postal Code

228-0815

Country

Japan

Facility Name

Research Site

City

Saitama-Ken

ZIP/Postal Code

338-8553

Country

Japan

Facility Name

Research Site

City

Sapporo-shi

ZIP/Postal Code

060-0033

Country

Japan

Facility Name

Research Site

City

Taito-ku

ZIP/Postal Code

111-0051

Country

Japan

Facility Name

Research Site

City

Toshima-ku

ZIP/Postal Code

171-0014

Country

Japan

Facility Name

Research Site

City

Yokkaichi-shi

ZIP/Postal Code

510-8567

Country

Japan

Facility Name

Research Site

City

Daugavpils

ZIP/Postal Code

LV-5401

Country

Latvia

Facility Name

Research Site

City

Rezekne

ZIP/Postal Code

LV-4600

Country

Latvia

Facility Name

Research Site

City

Riga

ZIP/Postal Code

1001

Country

Latvia

Facility Name

Research Site

City

Riga

ZIP/Postal Code

LV-1038

Country

Latvia

Facility Name

Research Site

City

Riga

ZIP/Postal Code

LV1002

Country

Latvia

Facility Name

Research Site

City

Riga

ZIP/Postal Code

LV1010

Country

Latvia

Facility Name

Research Site

City

Kaunas

ZIP/Postal Code

LT50009

Country

Lithuania

Facility Name

Research Site

City

Klaipeda

ZIP/Postal Code

92231

Country

Lithuania

Facility Name

Research Site

City

Klaipeda

ZIP/Postal Code

92288

Country

Lithuania

Facility Name

Research Site

City

Belgrade

ZIP/Postal Code

11000

Country

Serbia

Facility Name

Research Site

City

Kragujevac

ZIP/Postal Code

34000

Country

Serbia

Facility Name

Research Site

City

Sremska Kamenica

ZIP/Postal Code

21204

Country

Serbia

Facility Name

Research Site

City

Bardejov

ZIP/Postal Code

085 01

Country

Slovakia

Facility Name

Research Site

City

Bratislava

ZIP/Postal Code

84108

Country

Slovakia

Facility Name

Research Site

City

Ilava

ZIP/Postal Code

01901

Country

Slovakia

Facility Name

Research Site

City

Kosice

ZIP/Postal Code

040 01

Country

Slovakia

Facility Name

Research Site

City

Levice

ZIP/Postal Code

934 01

Country

Slovakia

Facility Name

Research Site

City

Nove Zamky

ZIP/Postal Code

940 01

Country

Slovakia

Facility Name

Research Site

City

Poprad

ZIP/Postal Code

058 01

Country

Slovakia

Facility Name

Research Site

City

Spisska Nova Ves

ZIP/Postal Code

052 01

Country

Slovakia

Facility Name

Research Site

City

Sturovo

ZIP/Postal Code

94301

Country

Slovakia

Facility Name

Research Site

City

Surany

ZIP/Postal Code

94201

Country

Slovakia

Facility Name

Research Site

City

Topolcany

ZIP/Postal Code

95501

Country

Slovakia

Facility Name

Research Site

City

Zvolen

ZIP/Postal Code

96001

Country

Slovakia

Facility Name

Research Site

City

Durban

ZIP/Postal Code

4068

Country

South Africa

Facility Name

Research Site

City

Middelburg

ZIP/Postal Code

1055

Country

South Africa

Facility Name

Research Site

City

Pretoria

ZIP/Postal Code

0181

Country

South Africa

Facility Name

Research Site

City

Pretoria

ZIP/Postal Code

0183

Country

South Africa

Facility Name

Research Site

City

Dnipropetrovsk

ZIP/Postal Code

49051

Country

Ukraine

Facility Name

Research Site

City

Ivano-Frankivsk

ZIP/Postal Code

76012

Country

Ukraine

Facility Name

Research Site

City

Kyiv

ZIP/Postal Code

02091

Country

Ukraine

Facility Name

Research Site

City

Kyiv

ZIP/Postal Code

03680

Country

Ukraine

Facility Name

Research Site

City

Kyiv

ZIP/Postal Code

04050

Country

Ukraine

Facility Name

Research Site

City

Mykolayiv

ZIP/Postal Code

54003

Country

Ukraine

Facility Name

Research Site

City

Odessa

ZIP/Postal Code

65039

Country

Ukraine

Facility Name

Research Site

City

Poltava

ZIP/Postal Code

36038

Country

Ukraine

Facility Name

Research Site

City

Suprunivka Vil., Poltava Regio

ZIP/Postal Code

36028

Country

Ukraine

Facility Name

Research Site

City

Vinnytsia

ZIP/Postal Code

21029

Country

Ukraine

Facility Name

Research Site

City

Zaporizhzhya

ZIP/Postal Code

69035

Country

Ukraine

Facility Name

Research Site

City

Zaporizhzhya

ZIP/Postal Code

69600

Country

Ukraine

12. IPD Sharing Statement

Citations:

PubMed Identifier

28877011

Citation

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.

Results Reference

background

PubMed Identifier

34913186

Citation

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.

Results Reference

derived

PubMed Identifier

34358701

Citation

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.

Results Reference

derived

PubMed Identifier

33368307

Citation

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.

Results Reference

derived

PubMed Identifier

33169672

Citation

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.

Results Reference

derived

Links:

URL

http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_7111&studyid=1887&filename=CD-RI-MEDI9929-1146_Protocol_Synopsis_Amendment_3_Redacted_04.03.17.pdf

Description

CD-RI-MEDI9929-1146_Protocol_Synopsis_Amendment_3_Redacted_04.03.17

URL

http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_7111&studyid=1887&filename=CD-RI-MEDI9929-1146_Protocol_Synopsis_Redacted_06.23.17.pdf

Description

CD-RI-MEDI9929-1146_Protocol_Synopsis_Redacted_06.23.17

Learn more about this trial

Study to Evaluate the Efficacy and Safety of MEDI9929 (AMG 157) in Adult Subjects With Inadequately Controlled, Severe Asthma

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Study to Evaluate the Efficacy and Safety of MEDI9929 (AMG 157) in Adult Subjects With Inadequately Controlled, Severe Asthma

Asthma

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial