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Completed

NCT Number: NCT01018550

AMG 853 Phase 2 Study in Subjects With Inadequately Controlled Asthma

The primary objective is to determine if AMG 853 is effective compared with placebo as measured by change in Asthma Control Questionnaire (ACQ) composite symptoms scores from baseline to week 12.

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Key information

Conditions

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

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Males or females 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 or equivalent.
  • Ongoing asthma symptoms with ACQ score ≥ 1.5 points

Exclusion criteria

  • History of chronic obstructive pulmonary disease or other chronic pulmonary condition other than asthma
  • Any uncontrolled, clinically significant systemic disease
  • Respiratory infection within 4 weeks of the screening visit

Treatment and study plan

AMG 853

Drug

AMG 853 5 mg (BID)

Placebo

Drug

Placebo

Primary outcomes

  1. The primary objective is to determine if AMG 853 is effective compared with placebo as measured by change in Asthma Control Questionnaire (ACQ) composite symptoms scores from baseline to week 12.

    Time frame: Baseline to Week 12

Secondary outcomes

  1. Evaluate the efficacy of AMG 853 as measured by use of rescue short-acting β-agonist (SABA)

    Time frame: Baseline to Week 12

  2. Evaluate the efficacy of AMG 853 as measured by daily symptom score (aggregate/night and individual symptoms; and symptom free days)

    Time frame: Baseline to Week 12

  3. Evaluate the efficacy of AMG 853 as measured by pre- and post-bronchodilator forced expiratory volume in 1 second (FEV1)

    Time frame: Baseline to Week 12

  4. Evaluate the efficacy of AMG 853 as measured by AM and PM peak expiratory flow rate (PEFR)

    Time frame: Baseline to Week 12

  5. Evaluate the efficacy of AMG 853 as measured by asthma quality of life questionnaire (AQLQ)

    Time frame: Baseline to Week 12

Sponsors and collaborators

Lead sponsor

Amgen

Industry

Registry information

Official study title

A Randomized, Double-Blind, Placebo Controlled, Multiple Dose Phase 2 Study to Determine the Safety and Efficacy of AMG 853 in Subjects With Inadequately Controlled Asthma

Important dates

Study start
2009
Primary completion
2010
Study completion
2011
First posted
Nov 23, 2009
Registry last updated
Mar 23, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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