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Study of Efficacy and Safety of Brodalumab Compared With Placebo in Adults With Inadequately Controlled Asthma With High Bronchodilator Reversibility

Primary Purpose

Asthma

Status

Terminated

Phase

Phase 2

Locations

International

Study Type

Interventional

Intervention

Placebo

Brodalumab

About this trial

This is an interventional treatment trial for Asthma focused on measuring Inadequately controlled asthma, brodalumab, AMG 827

Eligibility Criteria

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

Inclusion Criteria:

Diagnosis of asthma, and presently has reversibility over pre-bronchodilator forced expiratory volume in 1 second (FEV1) of ≥ 20% at screening
Percent of predicted FEV1 ≥ 40% and ≤ 80% at screening
Inhaled corticosteroid (ICS) ≥ 200 and ≤ 1000/μg/day fluticasone powder or equivalent
Ongoing asthma symptoms with asthma control questionnaire (ACQ) composite score at screening and baseline ≥ 1.5 points

Exclusion Criteria:

History of chronic obstructive pulmonary disease (COPD) or other chronic pulmonary condition other than asthma
History of allergic bronchopulmonary aspergillosis
Respiratory infection within 4 weeks of screening or 1 week of baseline visit
Subject has known history of Crohn's disease
Subject has any other significant concurrent medical condition of laboratory abnormalities, as defined in the study protocol
Subject has previously used any anti-interleukin-17 (IL17) biologic therapy
Subject is pregnant or breastfeeding, or planning to become pregnant while enrolled in the study
Female subject is unwilling to use highly effective methods of birth control unless 2 years post-menopausal or surgically sterile
Subject has severe depression measured by Personal Health Questionnaire Depression Scale (PHQ-8) or suicidal ideation/behavior as measured by and Columbia Suicide Severity Rating Scale (e-CSSRS)
Subject has a history or evidence of psychiatric disorder or substance abuse considered by the Investigator to pose a risk to subject safety

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Placebo

Brodalumab 210 mg

Arm Description

Participants received placebo administered by subcutaneous injection on day 1, week 1, week 2 and every 2 weeks thereafter for 24 weeks.

Participants received 210 mg brodalumab administered by subcutaneous injection on day 1, week 1, week 2, and every 2 weeks thereafter for 24 weeks.

Outcomes

Primary Outcome Measures

Change From Baseline in Asthma Control Questionnaire (ACQ) Composite Score at Week 24

The ACQ is a validated instrument used in clinical research and practice to evaluate asthma control/impairment. The ACQ assesses disease control by evaluating 7 questions: night time awakenings, asthma symptoms upon wakening, activity limitation, shortness of breath, wheeze frequency, short-acting bronchodilator use, and FEV1. All seven items are scored on a 7-point scale, with 0 indicating good control and 6 indicating poor control; the total score is the mean of the seven items and ranges from 0 (totally-controlled) to 6 (extremely poorly controlled). A negative change from baseline indicates improvement. A change of 0.50 points is considered clinically meaningful and a total score of < 1.0 indicates good asthma control.

Secondary Outcome Measures

Asthma Exacerbation Rate

The asthma exacerbation event rate is defined as the number of events per subject-year during the 24 week treatment period. An asthma exacerbation was defined as an asthma worsening that requires systemic corticosteroids for at least 3 days during the study; distinct asthma exacerbations were defined as events with start dates more than 10 days apart from each other.

Change From Baseline in ACQ Composite Score at Week 24 in ICS+LABA Subpopulation

Asthma Exacerbation Rate in ICS+LABA Subpopulation

Change From Baseline in Daily Asthma Symptom Score (7-day Average Score)

The Asthma Symptom Diary (ASD) consists of 23 questions answered on a handheld device, including 10 asthma symptom-related items (5 answered in the morning and 5 in the evening). The morning diary comprises questions on 4 asthma-related symptoms (wheezing, shortness of breath, cough, chest tightness), rated on a 5-point severity scale from 0 (no symptom) to 4 (very severe symptoms), and 1 question on nocturnal awakenings, rated from 0 (did not wake up) to 4 (unable to sleep due to asthma). The evening diary has questions on the same 4 asthma-related symptoms and 1 question on limitations of activities, rated from 0 (not at all) to 4 (extremely). The ASD daily score is computed by averaging the responses to the 10 symptom-related items, and the mean 7-day ASD score is calculated by averaging the 7 daily scores, with the final score ranging from 0 (minimal symptoms) to 4 (very severe symptoms).

Change From Baseline in Pre-bronchodilator Forced Expiratory Volume in One Second (FEV1)

Change From Baseline in Daily Rescue Short-acting Beta-agonist Use

Participants were permitted allowed to use their inhaled rescue medication (SABA) as needed throughout the study and the use was captured in the daily electronic diary (eDiary).

Time to First Asthma Exacerbation

An asthma exacerbation is defined as an asthma worsening that requires systemic corticosteroids for at least 3 days during the study. Median time to first asthma exacerbation could not be estimated, the percentage of participants with an asthma exacerbation is reported.

Number of Participants Who Experienced an Asthma Exacerbation

An asthma exacerbation is defined as an asthma worsening that requires systemic corticosteroids for at least 3 days during the study.

Change From Baseline in Asthma Quality of Life Questionnaire (AQLQ) Overall Score

The AQLQ is an asthma-specific instrument that includes evaluations of both symptoms and health-related quality of life measures. The 32-item instrument measures 4 domains affected by asthma including activity limitations, emotional function, exposure to environmental stimuli, and symptoms. Participants were asked to recall their experiences during the last 2 weeks and to respond to each question on a 7-point scale (7=no impairment, 1=severe impairment). The overall score was calculated as mean of the responses to the 32 questions and ranges from 1 (severe impairment) to 7 (no impairment). A positive change from baseline indicates improvement.

Change From Baseline in Morning and Evening Peak Expiratory Flow Rate (PEFR)

Peak expiratory flow rate was measured by the participant twice daily at approximately the same time each day (eg, within 1 hour of waking and immediately before bedtime) using a peak flow meter.

Change From Baseline in Variation of Peak Flow

Peak flow was measured by the participant twice daily at approximately the same time each day (eg, within 1 hour of waking and immediately before bedtime) using a peak flow meter. The variation of peak flow is defined as the absolute value of the difference between the A.M. and P.M. peak flow in one day for an individual participant.

Proportion of Asthma Symptom-free Days in 4-weeks Intervals Over the Treatment Period

Asthma symptom-free days is defined as days that a participant had a score of zero in their daily asthma symptom diary score. The ASD consists of 23 questions answered on a handheld device, including 10 asthma symptom-related items (5 answered in the morning and 5 in the evening). The morning diary comprises questions on 4 asthma-related symptoms (wheezing, shortness of breath, cough, chest tightness), rated on a 5-point severity scale from 0 (no symptom) to 4 (very severe symptoms), and 1 question on nocturnal awakenings, rated from 0 (did not wake up) to 4 (unable to sleep due to asthma). The evening diary has questions on the same 4 asthma-related symptoms and 1 question on limitations of activities, rated from 0 (not at all) to 4 (extremely). The daily score is the average of the responses to the 10 items.

Serum Brodalumab Concentration

Serum brodalumab concentrations were measured using an enzyme-linked immunosorbent assay (ELISA). The lower limit of quantification (LLOQ) = 0.0500 µg/mL; values below the LLOQ were set to zero.

Full Information

NCT ID

NCT01902290

First Posted

May 22, 2013

Last Updated

September 8, 2022

Sponsor

Amgen

Collaborators

Kyowa Kirin Co., Ltd., AstraZeneca

1. Study Identification

Unique Protocol Identification Number

NCT01902290

Brief Title

Study of Efficacy and Safety of Brodalumab Compared With Placebo in Adults With Inadequately Controlled Asthma With High Bronchodilator Reversibility

Official Title

A Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety and Efficacy of Brodalumab in Subjects With Inadequately Controlled Asthma and High Bronchodilator Reversibility

Study Type

Interventional

2. Study Status

Record Verification Date

September 2022

Overall Recruitment Status

Terminated

Why Stopped

Study terminated early due to lack of efficacy observed following interim analysis in Q2 2015. Study Closed once all sites were closed in eClinical

Study Start Date

May 22, 2013 (Actual)

Primary Completion Date

May 15, 2015 (Actual)

Study Completion Date

May 15, 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Amgen

Collaborators

Kyowa Kirin Co., Ltd., AstraZeneca

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

The purpose of this study is to determine if brodalumab (AMG 827) is safe and effective compared to placebo as measured by change in Asthma Control Questionnaire (ACQ) composite scores.

6. Conditions and Keywords

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

Asthma

Keywords

Inadequately controlled asthma, brodalumab, AMG 827

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

421 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Participants received placebo administered by subcutaneous injection on day 1, week 1, week 2 and every 2 weeks thereafter for 24 weeks.

Arm Title

Brodalumab 210 mg

Arm Type

Experimental

Arm Description

Participants received 210 mg brodalumab administered by subcutaneous injection on day 1, week 1, week 2, and every 2 weeks thereafter for 24 weeks.

Intervention Type

Biological

Intervention Name(s)

Placebo

Intervention Description

Placebo administered subcutaneously

Intervention Type

Biological

Intervention Name(s)

Brodalumab

Other Intervention Name(s)

AMG 827

Intervention Description

Brodalumab administered subcutaneously

Primary Outcome Measure Information:

Title

Change From Baseline in Asthma Control Questionnaire (ACQ) Composite Score at Week 24

Description

Time Frame

Baseline and week 24

Secondary Outcome Measure Information:

Title

Asthma Exacerbation Rate

Description

Time Frame

Baseline to week 24

Title

Change From Baseline in ACQ Composite Score at Week 24 in ICS+LABA Subpopulation

Description

Time Frame

Baseline and week 24

Title

Asthma Exacerbation Rate in ICS+LABA Subpopulation

Description

Time Frame

Baseline to week 24

Title

Change From Baseline in Daily Asthma Symptom Score (7-day Average Score)

Description

Time Frame

Baseline and week 24

Title

Change From Baseline in Pre-bronchodilator Forced Expiratory Volume in One Second (FEV1)

Time Frame

Baseline and week 24

Title

Change From Baseline in Daily Rescue Short-acting Beta-agonist Use

Description

Participants were permitted allowed to use their inhaled rescue medication (SABA) as needed throughout the study and the use was captured in the daily electronic diary (eDiary).

Time Frame

Baseline and week 24

Title

Time to First Asthma Exacerbation

Description

Time Frame

From first dose of study drug to week 24

Title

Number of Participants Who Experienced an Asthma Exacerbation

Description

An asthma exacerbation is defined as an asthma worsening that requires systemic corticosteroids for at least 3 days during the study.

Time Frame

Baseline to week 24

Title

Change From Baseline in Asthma Quality of Life Questionnaire (AQLQ) Overall Score

Description

Time Frame

Baseline and week 24

Title

Change From Baseline in Morning and Evening Peak Expiratory Flow Rate (PEFR)

Description

Peak expiratory flow rate was measured by the participant twice daily at approximately the same time each day (eg, within 1 hour of waking and immediately before bedtime) using a peak flow meter.

Time Frame

Baseline and week 24

Title

Change From Baseline in Variation of Peak Flow

Description

Time Frame

Baseline and week 24

Title

Proportion of Asthma Symptom-free Days in 4-weeks Intervals Over the Treatment Period

Description

Time Frame

Baseline (the 4 weeks prior to first dose) and 4-week intervals up to week 24

Title

Serum Brodalumab Concentration

Description

Serum brodalumab concentrations were measured using an enzyme-linked immunosorbent assay (ELISA). The lower limit of quantification (LLOQ) = 0.0500 µg/mL; values below the LLOQ were set to zero.

Time Frame

Day 1 and weeks 1, 2, 4, 8, 12, 16, and 22 at predose, week 2 + 3 days, week 22 + 3, 7, 10, and 14 days

Other Pre-specified Outcome Measures:

Title

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

Description

Adverse events were graded for severity according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4. The investigator assessed whether the adverse event was possibly related to the investigational product. A serious adverse event is defined as an adverse event that meets at least 1 of the following serious criteria: fatal; life threatening; requires in-patient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; congenital anomaly/birth defect; other medically important serious event.

Time Frame

From first dose of study drug up to the end of study, 28 weeks

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: Diagnosis of asthma, and presently has reversibility over pre-bronchodilator forced expiratory volume in 1 second (FEV1) of ≥ 20% at screening Percent of predicted FEV1 ≥ 40% and ≤ 80% at screening Inhaled corticosteroid (ICS) ≥ 200 and ≤ 1000/μg/day fluticasone powder or equivalent Ongoing asthma symptoms with asthma control questionnaire (ACQ) composite score at screening and baseline ≥ 1.5 points Exclusion Criteria: History of chronic obstructive pulmonary disease (COPD) or other chronic pulmonary condition other than asthma History of allergic bronchopulmonary aspergillosis Respiratory infection within 4 weeks of screening or 1 week of baseline visit Subject has known history of Crohn's disease Subject has any other significant concurrent medical condition of laboratory abnormalities, as defined in the study protocol Subject has previously used any anti-interleukin-17 (IL17) biologic therapy Subject is pregnant or breastfeeding, or planning to become pregnant while enrolled in the study Female subject is unwilling to use highly effective methods of birth control unless 2 years post-menopausal or surgically sterile Subject has severe depression measured by Personal Health Questionnaire Depression Scale (PHQ-8) or suicidal ideation/behavior as measured by and Columbia Suicide Severity Rating Scale (e-CSSRS) Subject has a history or evidence of psychiatric disorder or substance abuse considered by the Investigator to pose a risk to subject safety

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Organizational Affiliation

Amgen

Official's Role

Study Director

Facility Information:

Facility Name

Research Site

City

Birmingham

State/Province

Alabama

ZIP/Postal Code

35209

Country

United States

Facility Name

Research Site

City

Glendale

State/Province

Arizona

ZIP/Postal Code

85306

Country

United States

Facility Name

Research Site

City

Phoenix

State/Province

Arizona

ZIP/Postal Code

85006

Country

United States

Facility Name

Research Site

City

Scottsdale

State/Province

Arizona

ZIP/Postal Code

85251

Country

United States

Facility Name

Research Site

City

Little Rock

State/Province

Arkansas

ZIP/Postal Code

72205

Country

United States

Facility Name

Research Site

City

Bakersfield

State/Province

California

ZIP/Postal Code

93301

Country

United States

Facility Name

Research Site

City

Encinitas

State/Province

California

ZIP/Postal Code

92024

Country

United States

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

Newport Beach

State/Province

California

ZIP/Postal Code

92663

Country

United States

Facility Name

Research Site

City

North Hollywood

State/Province

California

ZIP/Postal Code

91606

Country

United States

Facility Name

Research Site

City

Orange

State/Province

California

ZIP/Postal Code

92868

Country

United States

Facility Name

Research Site

City

Palmdale

State/Province

California

ZIP/Postal Code

93551

Country

United States

Facility Name

Research Site

City

Rolling Hills Estates

State/Province

California

ZIP/Postal Code

90274

Country

United States

Facility Name

Research Site

City

San Diego

State/Province

California

ZIP/Postal Code

92103

Country

United States

Facility Name

Research Site

City

San Diego

State/Province

California

ZIP/Postal Code

92108

Country

United States

Facility Name

Research Site

City

San Jose

State/Province

California

ZIP/Postal Code

95117

Country

United States

Facility Name

Research Site

City

Santa Monica

State/Province

California

ZIP/Postal Code

90404

Country

United States

Facility Name

Research Site

City

Stockton

State/Province

California

ZIP/Postal Code

95207

Country

United States

Facility Name

Research Site

City

Colorado Springs

State/Province

Colorado

ZIP/Postal Code

80907

Country

United States

Facility Name

Research Site

City

Waterbury

State/Province

Connecticut

ZIP/Postal Code

06708

Country

United States

Facility Name

Research Site

City

Aventura

State/Province

Florida

ZIP/Postal Code

33180

Country

United States

Facility Name

Research Site

City

Hialeah

State/Province

Florida

ZIP/Postal Code

33012

Country

United States

Facility Name

Research Site

City

Jacksonville

State/Province

Florida

ZIP/Postal Code

32256

Country

United States

Facility Name

Research Site

City

Lynn Haven

State/Province

Florida

ZIP/Postal Code

32444

Country

United States

Facility Name

Research Site

City

Miami

State/Province

Florida

ZIP/Postal Code

33173

Country

United States

Facility Name

Research Site

City

Orlando

State/Province

Florida

ZIP/Postal Code

32806

Country

United States

Facility Name

Research Site

City

Port Orange

State/Province

Florida

ZIP/Postal Code

32127

Country

United States

Facility Name

Research Site

City

Tallahassee

State/Province

Florida

ZIP/Postal Code

32308

Country

United States

Facility Name

Research Site

City

Decatur

State/Province

Georgia

ZIP/Postal Code

30033

Country

United States

Facility Name

Research Site

City

Lawrenceville

State/Province

Georgia

ZIP/Postal Code

30046

Country

United States

Facility Name

Research Site

City

Eagle

State/Province

Idaho

ZIP/Postal Code

83616

Country

United States

Facility Name

Research Site

City

Chicago

State/Province

Illinois

ZIP/Postal Code

60616

Country

United States

Facility Name

Research Site

City

Chicago

State/Province

Illinois

ZIP/Postal Code

60637

Country

United States

Facility Name

Research Site

City

Normal

State/Province

Illinois

ZIP/Postal Code

61761

Country

United States

Facility Name

Research Site

City

Peoria

State/Province

Illinois

ZIP/Postal Code

61603

Country

United States

Facility Name

Research Site

City

Iowa City

State/Province

Iowa

ZIP/Postal Code

52242

Country

United States

Facility Name

Research Site

City

Paducah

State/Province

Kentucky

ZIP/Postal Code

42003

Country

United States

Facility Name

Research Site

City

Baltimore

State/Province

Maryland

ZIP/Postal Code

21224

Country

United States

Facility Name

Research Site

City

Baltimore

State/Province

Maryland

ZIP/Postal Code

21236

Country

United States

Facility Name

Research Site

City

North Dartmouth

State/Province

Massachusetts

ZIP/Postal Code

02747

Country

United States

Facility Name

Research Site

City

Plymouth

State/Province

Minnesota

ZIP/Postal Code

55441

Country

United States

Facility Name

Research Site

City

Jackson

State/Province

Mississippi

ZIP/Postal Code

39216

Country

United States

Facility Name

Research Site

City

Saint Louis

State/Province

Missouri

ZIP/Postal Code

63110

Country

United States

Facility Name

Research Site

City

Bellevue

State/Province

Nebraska

ZIP/Postal Code

68123

Country

United States

Facility Name

Research Site

City

Ocean City

State/Province

New Jersey

ZIP/Postal Code

07712

Country

United States

Facility Name

Research Site

City

Albuquerque

State/Province

New Mexico

ZIP/Postal Code

87109

Country

United States

Facility Name

Research Site

City

Rochester

State/Province

New York

ZIP/Postal Code

14618

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

High Point

State/Province

North Carolina

ZIP/Postal Code

27262

Country

United States

Facility Name

Research Site

City

Winston-Salem

State/Province

North Carolina

ZIP/Postal Code

27103

Country

United States

Facility Name

Research Site

City

Cincinnati

State/Province

Ohio

ZIP/Postal Code

45231

Country

United States

Facility Name

Research Site

City

Dublin

State/Province

Ohio

ZIP/Postal Code

43016

Country

United States

Facility Name

Research Site

City

Middleburg Heights

State/Province

Ohio

ZIP/Postal Code

44130

Country

United States

Facility Name

Research Site

City

Oklahoma City

State/Province

Oklahoma

ZIP/Postal Code

73103

Country

United States

Facility Name

Research Site

City

Lake Oswego

State/Province

Oregon

ZIP/Postal Code

97035

Country

United States

Facility Name

Research Site

City

Medford

State/Province

Oregon

ZIP/Postal Code

97504

Country

United States

Facility Name

Research Site

City

Portland

State/Province

Oregon

ZIP/Postal Code

97202

Country

United States

Facility Name

Research Site

City

Upland

State/Province

Pennsylvania

ZIP/Postal Code

19013

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

Bristol

State/Province

Tennessee

ZIP/Postal Code

37620

Country

United States

Facility Name

Research Site

City

Nashville

State/Province

Tennessee

ZIP/Postal Code

37203-1424

Country

United States

Facility Name

Research Site

City

Nashville

State/Province

Tennessee

ZIP/Postal Code

37214

Country

United States

Facility Name

Research Site

City

Arlington

State/Province

Texas

ZIP/Postal Code

76018

Country

United States

Facility Name

Research Site

City

Dallas

State/Province

Texas

ZIP/Postal Code

75231

Country

United States

Facility Name

Research Site

City

El Paso

State/Province

Texas

ZIP/Postal Code

79903

Country

United States

Facility Name

Research Site

City

McKinney

State/Province

Texas

ZIP/Postal Code

75069

Country

United States

Facility Name

Research Site

City

San Antonio

State/Province

Texas

ZIP/Postal Code

78229

Country

United States

Facility Name

Research Site

City

San Antonio

State/Province

Texas

ZIP/Postal Code

78258

Country

United States

Facility Name

Research Site

City

Clinton

State/Province

Utah

ZIP/Postal Code

84015

Country

United States

Facility Name

Research Site

City

Bellingham

State/Province

Washington

ZIP/Postal Code

98225

Country

United States

Facility Name

Research Site

City

Milwaukee

State/Province

Wisconsin

ZIP/Postal Code

53226

Country

United States

Facility Name

Research Site

City

New Lambton

State/Province

New South Wales

ZIP/Postal Code

2305

Country

Australia

Facility Name

Research Site

City

Nedlands

State/Province

Western Australia

ZIP/Postal Code

6009

Country

Australia

Facility Name

Research Site

City

Sherwood Park

State/Province

Alberta

ZIP/Postal Code

T8H 0N2

Country

Canada

Facility Name

Research Site

City

Kelowna

State/Province

British Columbia

ZIP/Postal Code

V1W 1V3

Country

Canada

Facility Name

Research Site

City

Surrey

State/Province

British Columbia

ZIP/Postal Code

V3T 0G9

Country

Canada

Facility Name

Research Site

City

Vancouver

State/Province

British Columbia

ZIP/Postal Code

V5Z 1M9

Country

Canada

Facility Name

Research Site

City

Vancouver

State/Province

British Columbia

ZIP/Postal Code

V6J 1S3

Country

Canada

Facility Name

Research Site

City

Brampton

State/Province

Ontario

ZIP/Postal Code

L6T 0G1

Country

Canada

Facility Name

Research Site

City

Hamilton

State/Province

Ontario

ZIP/Postal Code

L8N 3Z5

Country

Canada

Facility Name

Research Site

City

Newmarket

State/Province

Ontario

ZIP/Postal Code

L3Y 5G8

Country

Canada

Facility Name

Research Site

City

Sarnia

State/Province

Ontario

ZIP/Postal Code

N7T 4X3

Country

Canada

Facility Name

Research Site

City

Toronto

State/Province

Ontario

ZIP/Postal Code

M5T 3A9

Country

Canada

Facility Name

Research Site

City

Toronto

State/Province

Ontario

ZIP/Postal Code

M9V 4B4

Country

Canada

Facility Name

Research Site

City

Trois Rivieres

State/Province

Quebec

ZIP/Postal Code

G8T 7A1

Country

Canada

Facility Name

Research Site

City

Le Kremlin Bicetre

ZIP/Postal Code

94270

Country

France

Facility Name

Research Site

City

Marseille

ZIP/Postal Code

13015

Country

France

Facility Name

Research Site

City

Montpellier cedex 05

ZIP/Postal Code

34295

Country

France

Facility Name

Research Site

City

Pessac Cedex

ZIP/Postal Code

33604

Country

France

Facility Name

Research Site

City

Saint Herblain

ZIP/Postal Code

44805

Country

France

Facility Name

Research Site

City

Strasbourg cedex

ZIP/Postal Code

67091

Country

France

Facility Name

Research Site

City

Tours Cedex 9

ZIP/Postal Code

37044

Country

France

Facility Name

Research Site

City

Berlin

ZIP/Postal Code

10717

Country

Germany

Facility Name

Research Site

City

Berlin

ZIP/Postal Code

12099

Country

Germany

Facility Name

Research Site

City

Bonn

ZIP/Postal Code

53119

Country

Germany

Facility Name

Research Site

City

Cottbus

ZIP/Postal Code

03050

Country

Germany

Facility Name

Research Site

City

Frankfurt am Main

ZIP/Postal Code

60596

Country

Germany

Facility Name

Research Site

City

Hamburg

ZIP/Postal Code

22299

Country

Germany

Facility Name

Research Site

City

Hannover

ZIP/Postal Code

30173

Country

Germany

Facility Name

Research Site

City

Mainz

ZIP/Postal Code

55131

Country

Germany

Facility Name

Research Site

City

Radebeul

ZIP/Postal Code

01445

Country

Germany

Facility Name

Research Site

City

Rüdersdorf

ZIP/Postal Code

15562

Country

Germany

Facility Name

Research Site

City

Alexandroupoli

ZIP/Postal Code

68100

Country

Greece

Facility Name

Research Site

City

Athens

ZIP/Postal Code

10676

Country

Greece

Facility Name

Research Site

City

Athens

ZIP/Postal Code

11527

Country

Greece

Facility Name

Research Site

City

Athens

ZIP/Postal Code

11528

Country

Greece

Facility Name

Research Site

City

Athens

ZIP/Postal Code

15125

Country

Greece

Facility Name

Research Site

City

Chaidari, Athens

ZIP/Postal Code

12462

Country

Greece

Facility Name

Research Site

City

Heraklion - Crete

ZIP/Postal Code

71110

Country

Greece

Facility Name

Research Site

City

Thessaloniki

ZIP/Postal Code

57010

Country

Greece

Facility Name

Research Site

City

Hong Kong

Country

Hong Kong

Facility Name

Research Site

City

New Territories

Country

Hong Kong

Facility Name

Research Site

City

Cork

Country

Ireland

Facility Name

Research Site

City

Dublin

ZIP/Postal Code

Country

Ireland

Facility Name

Research Site

City

Dublin

ZIP/Postal Code

Country

Ireland

Facility Name

Research Site

City

Dublin

Country

Ireland

Facility Name

Research Site

City

Catania

ZIP/Postal Code

95123

Country

Italy

Facility Name

Research Site

City

Ferrara

ZIP/Postal Code

44121

Country

Italy

Facility Name

Research Site

City

Genova

ZIP/Postal Code

16132

Country

Italy

Facility Name

Research Site

City

Modena

ZIP/Postal Code

41124

Country

Italy

Facility Name

Research Site

City

Padova

ZIP/Postal Code

35128

Country

Italy

Facility Name

Research Site

City

Pavia

ZIP/Postal Code

27100

Country

Italy

Facility Name

Research Site

City

Pisa

ZIP/Postal Code

56124

Country

Italy

Facility Name

Research Site

City

Tradate (VA)

ZIP/Postal Code

21049

Country

Italy

Facility Name

Research Site

City

Bucheon-si, Gyeonggi-do

ZIP/Postal Code

420-767

Country

Korea, Republic of

Facility Name

Research Site

City

Incheon

ZIP/Postal Code

405-760

Country

Korea, Republic of

Facility Name

Research Site

City

Seoul

ZIP/Postal Code

142-703

Country

Korea, Republic of

Facility Name

Research Site

City

Wonju-si, Gangwon-do

ZIP/Postal Code

220-710

Country

Korea, Republic of

Facility Name

Research Site

City

Christchurch

ZIP/Postal Code

8140

Country

New Zealand

Facility Name

Research Site

City

Dunedin

ZIP/Postal Code

9058

Country

New Zealand

Facility Name

Research Site

City

Remuera

ZIP/Postal Code

1051

Country

New Zealand

Facility Name

Research Site

City

Bialystok

ZIP/Postal Code

15-010

Country

Poland

Facility Name

Research Site

City

Bialystok

ZIP/Postal Code

15-044

Country

Poland

Facility Name

Research Site

City

Gdynia

ZIP/Postal Code

81-338

Country

Poland

Facility Name

Research Site

City

Katowice

ZIP/Postal Code

40-954

Country

Poland

Facility Name

Research Site

City

Krakow

ZIP/Postal Code

31-011

Country

Poland

Facility Name

Research Site

City

Krakow

ZIP/Postal Code

31-024

Country

Poland

Facility Name

Research Site

City

Krakow

ZIP/Postal Code

31-637

Country

Poland

Facility Name

Research Site

City

Lublin

ZIP/Postal Code

59-300

Country

Poland

Facility Name

Research Site

City

Skierniewice

ZIP/Postal Code

96-100

Country

Poland

Facility Name

Research Site

City

Tarnow

ZIP/Postal Code

33-100

Country

Poland

Facility Name

Research Site

City

Warszawa

ZIP/Postal Code

01-868

Country

Poland

Facility Name

Research Site

City

Warszawa

ZIP/Postal Code

02-097

Country

Poland

Facility Name

Research Site

City

Warszawa

ZIP/Postal Code

02-201

Country

Poland

Facility Name

Research Site

City

Warszawa

ZIP/Postal Code

04-141

Country

Poland

Facility Name

Research Site

City

Zgierz

ZIP/Postal Code

95-100

Country

Poland

Facility Name

Research Site

City

San Juan

ZIP/Postal Code

00917

Country

Puerto Rico

Facility Name

Research Site

City

Moscow

ZIP/Postal Code

105077

Country

Russian Federation

Facility Name

Research Site

City

Moscow

ZIP/Postal Code

115280

Country

Russian Federation

Facility Name

Research Site

City

Moscow

ZIP/Postal Code

115446

Country

Russian Federation

Facility Name

Research Site

City

Moscow

ZIP/Postal Code

119991

Country

Russian Federation

Facility Name

Research Site

City

Moscow

ZIP/Postal Code

123182

Country

Russian Federation

Facility Name

Research Site

City

Moscow

ZIP/Postal Code

127018

Country

Russian Federation

Facility Name

Research Site

City

Saint Petersburg

ZIP/Postal Code

193231

Country

Russian Federation

Facility Name

Research Site

City

Saint Petersburg

ZIP/Postal Code

197022

Country

Russian Federation

Facility Name

Research Site

City

Saint-Petersburg

ZIP/Postal Code

195271

Country

Russian Federation

Facility Name

Research Site

City

Taipei

ZIP/Postal Code

10002

Country

Taiwan

Facility Name

Research Site

City

Taipei

ZIP/Postal Code

112

Country

Taiwan

Facility Name

Research Site

City

Taipei

ZIP/Postal Code

22050

Country

Taiwan

12. IPD Sharing Statement

Citations:

PubMed Identifier

30945020

Citation

Globe G, Wiklund I, Mattera M, Zhang H, Revicki DA. Evaluating minimal important differences and responder definitions for the asthma symptom diary in patients with moderate to severe asthma. J Patient Rep Outcomes. 2019 Apr 3;3(1):22. doi: 10.1186/s41687-019-0109-2.

Results Reference

background

Links:

URL

http://www.amgentrials.com

Description

AmgenTrials clinical trials website

Learn more about this trial

Study of Efficacy and Safety of Brodalumab Compared With Placebo in Adults With Inadequately Controlled Asthma With High Bronchodilator Reversibility

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Study of Efficacy and Safety of Brodalumab Compared With Placebo in Adults With Inadequately Controlled Asthma With High Bronchodilator Reversibility

Asthma

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

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