A Study to Evaluate the Dosing of AMG 827 for Subjects With Inadequately Controlled Asthma

NCT01199289 | Completed Phase 2 Results

• 1 other identifier: 20090203
• Study Type: interventional
• Target: 315
• Locations: 10 countries
• Sites: 49

Brief Summary

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

Conditions

Asthma

Keywords

Amgen; chronic inflammatory disease; wheezing

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in Asthma Control Questionnaire (ACQ) Composite Scores to Week 12

  The ACQ is an instrument used in clinical research and practice to evaluate asthma control/impairment. It is a validated composite score that assesses disease control by evaluating 7 questions: night time awakenings, asthma symptoms upon awakening, activity limitation, shortness of breath, wheeze frequency, short-acting bronchodilator use, and forced expiratory volume in 1 second (FEV1). The response options for all these questions range from zero (no impairment/limitation) to six (total impairment/limitation) scale. The total score is obtained by adding the value from each question and dividing by the number of questions. Higher scores indicates worsening of condition and a negative change from baseline indicates improvement.

  Baseline and Week 12

Secondary Outcomes (9)

• Change From Baseline in Pre- and Post-Bronchodilator Forced Expiratory Volume in 1 Second (FEV1)

  Baseline and Week 12

• Change From Baseline in AM and PM Peak Expiratory Flow Rate (PEFR) to Week 12

  Baseline and Week 12

• Change From Baseline in the Frequency of Rescue Short Acting β-Agonist (SABA) Use to Week 12

  Baseline to Week 12

• Change From Baseline in Daily Asthma Symptom Score to Week 12

  Baseline and Week 12

• Change From Baseline in Asthma Quality of Life Questionnaire (AQLQ) Score at Week 12

  Baseline and Week 12

Study Arms (4)

Placebo

PLACEBO COMPARATOR

Participants will receive the matching placebo administered as subcutaneous (SC) injections at Day 1 and weeks 1, 2, 4, 6, 8, and 10.

Drug: Placebo

AMG 827 140 mg

EXPERIMENTAL

Participants will receive AMG 140 mg administered as SC injections at Day 1 and weeks 1, 2, 4, 6, 8, and 10.

Drug: AMG 827

AMG 827 210 mg

EXPERIMENTAL

Participants will receive AMG 210 mg administered as SC injections at Day 1 and weeks 1, 2, 4, 6, 8, and 10.

Drug: AMG 827

AMG 827 280 mg

EXPERIMENTAL

Participants will receive AMG 280 mg administered as SC injections at Day 1 and weeks 1, 2, 4, 6, 8, and 10.

Drug: AMG 827

Interventions

AMG 827 DRUG

SC injection.

AMG 827 140 mg; AMG 827 210 mg; AMG 827 280 mg

Placebo DRUG

SC injection.

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Men or women 18 to 65 years of age
• Percent of predicted FEV1 ≥ 50% and ≤ 80%
• At least 12% reversibility over pre-bronchodilator FEV1
• Inhaled corticosteroid (ICS) ≥ 200 and ≤ 1000 µg/day fluticasone powder or equivalent
• Ongoing asthma symptoms with ACQ composite score ≥ 1.5 points

You may not qualify if:

• Respiratory infection within 4 weeks of screening visit or 1 week of baseline visit
• History of chronic obstructive pulmonary disease or other chronic pulmonary condition other than asthma
• Any uncontrolled or clinically significant systemic disease (eg, uncontrolled diabetes, liver disease)

Sponsors & Collaborators

• Amgen: lead

Study Sites (49)

Research Site

Encinitas, California, United States

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Huntington Beach, California, United States

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Los Angeles, California, United States

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San Diego, California, United States

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Stockton, California, United States

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Colorado Springs, Colorado, United States

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Stockbridge, Georgia, United States

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Baltimore, Maryland, United States

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North Dartmouth, Massachusetts, United States

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St Louis, Missouri, United States

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Bozeman, Montana, United States

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Bellevue, Nebraska, United States

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Skillman, New Jersey, United States

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Rockville Centre, New York, United States

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High Point, North Carolina, United States

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Cincinnati, Ohio, United States

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Lake Oswego, Oregon, United States

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Medford, Oregon, United States

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Pittsburgh, Pennsylvania, United States

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Dallas, Texas, United States

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El Paso, Texas, United States

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Madison, Wisconsin, United States

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Feldbach, Austria

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Hallein, Austria

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Vienna, Austria

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Brussels, Belgium

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Leuven, Belgium

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Liège, Belgium

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Calgary, Alberta, Canada

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Ottawa, Ontario, Canada

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Toronto, Ontario, Canada

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Helsinki, Finland

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Jyväskylä, Finland

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Turku, Finland

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Edelény, Hungary

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Mátraháza, Hungary

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Tatabánya, Hungary

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Törökbálint, Hungary

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Zalaegerszeg - Pozva, Hungary

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Rotterdam, Netherlands

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Bialystok, Poland

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Chodzież, Poland

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Gdansk, Poland

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Wroclaw, Poland

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Moscow, Russia

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Saint Petersburg, Russia

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Bucheon-si, South Korea

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Seoul, South Korea

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Suwon, South Korea

Location

Related Publications (1)

• Busse WW, Holgate S, Kerwin E, Chon Y, Feng J, Lin J, Lin SL. Randomized, double-blind, placebo-controlled study of brodalumab, a human anti-IL-17 receptor monoclonal antibody, in moderate to severe asthma. Am J Respir Crit Care Med. 2013 Dec 1;188(11):1294-302. doi: 10.1164/rccm.201212-2318OC.

  PMID: 24200404 BACKGROUND

Related Links

• AmgenTrials clinical trials website

MeSH Terms

Conditions

Asthma; Respiratory Sounds

Interventions

brodalumab

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Limitations and Caveats

10 participants from 1 site were excluded from all analysis due to major GCP violations.

Results Point of Contact

• Title: Study Director
• Organization: Amgen Inc.

medinfo@amgen.com

866-572-6436

Study Officials

• MD

  Amgen

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 5, 2010
• First Posted: September 10, 2010
• Study Start: October 4, 2010
• Primary Completion: December 21, 2011
• Study Completion: December 21, 2011
• Last Updated: November 26, 2021
• Results First Posted: November 26, 2021

Record last verified: 2021-10

Locations

RU (2); BE (3); PL (4); AU (3); NL (1); US (22); FI (3); KR (3); CA (3); HU (5)