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

NCT01902290 | Terminated Phase 2 Results

• 2 other identifiers: 201201412012-003351-11
• Study Type: interventional
• Target: 421
• Locations: 15 countries
• Sites: 161

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.

Conditions

Asthma

Keywords

Inadequately controlled asthma, brodalumab, AMG 827

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline and week 24

Secondary Outcomes (13)

• Asthma Exacerbation Rate

  Baseline to week 24

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

  Baseline and week 24

• Asthma Exacerbation Rate in ICS+LABA Subpopulation

  Baseline to week 24

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

  Baseline and week 24

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

  Baseline and week 24

Other Outcomes (1)

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

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

Study Arms (2)

Placebo

PLACEBO COMPARATOR

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

Biological: Placebo

Brodalumab 210 mg

EXPERIMENTAL

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

Biological: Brodalumab

Interventions

Placebo BIOLOGICAL

Placebo administered subcutaneously

Placebo

Brodalumab BIOLOGICAL

Brodalumab administered subcutaneously

Also known as: AMG 827

Brodalumab 210 mg

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Amgen: lead
• Kyowa Kirin Co., Ltd.: collaborator
• AstraZeneca: collaborator

Study Sites (161)

Research Site

Birmingham, Alabama, 35209, United States

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Glendale, Arizona, 85306, United States

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Phoenix, Arizona, 85006, United States

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Scottsdale, Arizona, 85251, United States

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Little Rock, Arkansas, 72205, United States

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Bakersfield, California, 93301, United States

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Encinitas, California, 92024, United States

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Los Angeles, California, 90025, United States

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Los Angeles, California, 90048, United States

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Newport Beach, California, 92663, United States

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North Hollywood, California, 91606, United States

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Orange, California, 92868, United States

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Palmdale, California, 93551, United States

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Rolling Hills Estates, California, 90274, United States

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San Diego, California, 92103, United States

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San Diego, California, 92108, United States

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San Jose, California, 95117, United States

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Santa Monica, California, 90404, United States

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Stockton, California, 95207, United States

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Colorado Springs, Colorado, 80907, United States

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Waterbury, Connecticut, 06708, United States

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Aventura, Florida, 33180, United States

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Hialeah, Florida, 33012, United States

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Jacksonville, Florida, 32256, United States

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Lynn Haven, Florida, 32444, United States

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Miami, Florida, 33173, United States

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Orlando, Florida, 32806, United States

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Port Orange, Florida, 32127, United States

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Tallahassee, Florida, 32308, United States

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Decatur, Georgia, 30033, United States

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Lawrenceville, Georgia, 30046, United States

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Eagle, Idaho, 83616, United States

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Chicago, Illinois, 60616, United States

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Chicago, Illinois, 60637, United States

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Normal, Illinois, 61761, United States

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Peoria, Illinois, 61603, United States

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Iowa City, Iowa, 52242, United States

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Paducah, Kentucky, 42003, United States

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Baltimore, Maryland, 21224, United States

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Baltimore, Maryland, 21236, United States

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North Dartmouth, Massachusetts, 02747, United States

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Plymouth, Minnesota, 55441, United States

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Jackson, Mississippi, 39216, United States

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St Louis, Missouri, 63110, United States

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Bellevue, Nebraska, 68123, United States

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Ocean City, New Jersey, 07712, United States

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Albuquerque, New Mexico, 87109, United States

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Rochester, New York, 14618, United States

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Charlotte, North Carolina, 28207, United States

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High Point, North Carolina, 27262, United States

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Winston-Salem, North Carolina, 27103, United States

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Cincinnati, Ohio, 45231, United States

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Dublin, Ohio, 43016, United States

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Middleburg Heights, Ohio, 44130, United States

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Oklahoma City, Oklahoma, 73103, United States

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Lake Oswego, Oregon, 97035, United States

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Medford, Oregon, 97504, United States

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Portland, Oregon, 97202, United States

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Upland, Pennsylvania, 19013, United States

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Rock Hill, South Carolina, 29732, United States

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Spartanburg, South Carolina, 29303, United States

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Bristol, Tennessee, 37620, United States

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Nashville, Tennessee, 37203-1424, United States

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Nashville, Tennessee, 37214, United States

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Arlington, Texas, 76018, United States

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Dallas, Texas, 75231, United States

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El Paso, Texas, 79903, United States

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McKinney, Texas, 75069, United States

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San Antonio, Texas, 78229, United States

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San Antonio, Texas, 78258, United States

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Clinton, Utah, 84015, United States

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Bellingham, Washington, 98225, United States

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Milwaukee, Wisconsin, 53226, United States

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New Lambton, New South Wales, 2305, Australia

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Nedlands, Western Australia, 6009, Australia

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Sherwood Park, Alberta, T8H 0N2, Canada

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Kelowna, British Columbia, V1W 1V3, Canada

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Surrey, British Columbia, V3T 0G9, Canada

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Vancouver, British Columbia, V5Z 1M9, Canada

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Vancouver, British Columbia, V6J 1S3, Canada

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Brampton, Ontario, L6T 0G1, Canada

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Hamilton, Ontario, L8N 3Z5, Canada

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Newmarket, Ontario, L3Y 5G8, Canada

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Sarnia, Ontario, N7T 4X3, Canada

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Toronto, Ontario, M5T 3A9, Canada

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Toronto, Ontario, M9V 4B4, Canada

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Trois-Rivières, Quebec, G8T 7A1, Canada

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Le Kremlin-Bicêtre, 94270, France

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Marseille, 13015, France

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Montpellier, 34295, France

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Pessac, 33604, France

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Saint-Herblain, 44805, France

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Strasbourg, 67091, France

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Tours, 37044, France

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Berlin, 10717, Germany

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Berlin, 12099, Germany

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Bonn, 53119, Germany

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Cottbus, 03050, Germany

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Frankfurt am Main, 60596, Germany

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Hamburg, 22299, Germany

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Hanover, 30173, Germany

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Mainz, 55131, Germany

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Radebeul, 01445, Germany

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Rüdersdorf, 15562, Germany

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Alexandroupoli, 68100, Greece

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Athens, 10676, Greece

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Athens, 11527, Greece

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Athens, 11528, Greece

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Athens, 15125, Greece

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Chaidari, Athens, 12462, Greece

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Heraklion - Crete, 71110, Greece

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Thessaloniki, 57010, Greece

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Hong Kong, Hong Kong

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New Territories, Hong Kong

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Cork, Ireland

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Dublin, 15, Ireland

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Dublin, 24, Ireland

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Dublin, Ireland

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Catania, 95123, Italy

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Ferrara, 44121, Italy

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Genova, 16132, Italy

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Modena, 41124, Italy

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Padua, 35128, Italy

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Pavia, 27100, Italy

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Pisa, 56124, Italy

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Tradate (VA), 21049, Italy

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Christchurch, 8140, New Zealand

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Dunedin, 9058, New Zealand

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Remuera, 1051, New Zealand

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Bialystok, 15-010, Poland

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Bialystok, 15-044, Poland

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Gdynia, 81-338, Poland

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Katowice, 40-954, Poland

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Krakow, 31-011, Poland

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Krakow, 31-024, Poland

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Krakow, 31-637, Poland

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Lublin, 59-300, Poland

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Skierniewice, 96-100, Poland

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Tarnów, 33-100, Poland

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Warsaw, 01-868, Poland

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Warsaw, 02-097, Poland

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Warsaw, 02-201, Poland

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Warsaw, 04-141, Poland

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Zgierz, 95-100, Poland

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San Juan, 00917, Puerto Rico

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Moscow, 105077, Russia

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Moscow, 115280, Russia

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Moscow, 115446, Russia

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Moscow, 119991, Russia

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Moscow, 123182, Russia

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Moscow, 127018, Russia

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Saint Petersburg, 193231, Russia

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Saint Petersburg, 195271, Russia

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Saint Petersburg, 197022, Russia

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Bucheon-si, Gyeonggi-do, 420-767, South Korea

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Incheon, 405-760, South Korea

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Seoul, 142-703, South Korea

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Wonju-si, Gangwon-do, 220-710, South Korea

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Taipei, 10002, Taiwan

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Taipei, 112, Taiwan

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Taipei, 22050, Taiwan

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Related Publications (1)

• 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.

  PMID: 30945020 BACKGROUND

Related Links

• AmgenTrials clinical trials website

MeSH Terms

Conditions

Asthma

Interventions

brodalumab

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

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: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 22, 2013
• First Posted: July 18, 2013
• Study Start: May 22, 2013
• Primary Completion: May 15, 2015
• Study Completion: May 15, 2015
• Last Updated: September 21, 2022
• Results First Posted: February 28, 2022

Record last verified: 2022-09

Locations

AU (2); TW (3); PL (15); FR (7); US (73); RU (9); HK (2); IT (8); IE (4); GR (8); PR (1); DE (10); NZ (3); KR (4); CA (12)