Terminated/Withdrawn
Sponsor ID
20120141

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

Sponsor ID
20120141
Clinicaltrials.gov ID
NCT01902290
EUCTIS ID
N/A
EudraCT ID
2012-003351-11

Study Details

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.

Additional Study Details

Phase
Phase 2
Product
brodalumab
Type
Interventional
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment
421
Additional Study Details

Protocol Summary

Primary Outcome Measures

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

Timeframe: Baseline and week 24

Secondary Outcome Measures

Asthma Exacerbation Rate

Timeframe: Baseline to week 24

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

Timeframe: Baseline and week 24

Asthma Exacerbation Rate in ICS+LABA Subpopulation

Timeframe: Baseline to week 24

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

Timeframe: Baseline and week 24

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

Timeframe: Baseline and week 24

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

Timeframe: Baseline and week 24

Time to First Asthma Exacerbation

Timeframe: From first dose of study drug to week 24

Number of Participants who Experienced an Asthma Exacerbation

Timeframe: Baseline to week 24

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

Timeframe: Baseline and week 24

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

Timeframe: Baseline and week 24

Change from Baseline in Variation of Peak Flow

Timeframe: Baseline and week 24

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

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

Serum Brodalumab Concentration

Timeframe: 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

Study Documents

Study Synopsis
Available Language(s): English

Locations

Location
Status
Contact Us
Location
Research Site
Athens, Greece, 10676
Status
Recruiting
Location
Research Site
Athens, Greece, 11527
Status
Recruiting
Location
Research Site
Aventura, FL, United States, 33180
Status
Recruiting
Location
Research Site
Bakersfield, CA, United States, 93301
Status
Recruiting
Location
Research Site
Baltimore, MD, United States, 21236
Status
Recruiting
Location
Research Site
Bellevue, NE, United States, 68123
Status
Recruiting
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