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AMG 853 Phase 2 Study in Subjects With Inadequately Controlled Asthma

This study has been completed.
Sponsor:
Information provided by:
Amgen
ClinicalTrials.gov Identifier:
NCT01018550
First received: November 19, 2009
Last updated: May 19, 2011
Last verified: May 2011
  Purpose

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.


Condition Intervention Phase
Asthma
Drug: AMG 853
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official 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

Further study details as provided by Amgen:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Evaluate the efficacy of AMG 853 as measured by use of rescue short-acting β-agonist (SABA) [ Time Frame: Baseline to Week 12 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Evaluate the efficacy of AMG 853 as measured by AM and PM peak expiratory flow rate (PEFR) [ Time Frame: Baseline to Week 12 ] [ Designated as safety issue: No ]
  • Evaluate the efficacy of AMG 853 as measured by asthma quality of life questionnaire (AQLQ) [ Time Frame: Baseline to Week 12 ] [ Designated as safety issue: No ]

Enrollment: 397
Study Start Date: October 2009
Study Completion Date: March 2011
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: AMG 853 Drug: AMG 853
AMG 853 5 mg (BID)
Drug: AMG 853
AMG 853 200 mg (QD)
Drug: AMG 853
AMG 853 25 mg (BID)
Drug: AMG 853
AMG 853 100 mg (BID)
Placebo Comparator: Placebo Drug: Placebo
Placebo

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01018550

Sponsors and Collaborators
Amgen
Investigators
Study Director: MD Amgen
  More Information

Additional Information:
No publications provided

Responsible Party: Global Development Leader, Amgen Inc.
ClinicalTrials.gov Identifier: NCT01018550     History of Changes
Other Study ID Numbers: 20080615
Study First Received: November 19, 2009
Last Updated: May 19, 2011
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases
Lung Diseases
Lung Diseases, Obstructive
Respiratory Hypersensitivity
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on November 19, 2014