Back to resultsAMG 853 Phase 2 Study in Subjects With Inadequately Controlled Asthma
Primary Purpose
Asthma
Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
AMG 853
AMG 853
AMG 853
AMG 853
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Asthma
Eligibility 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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
AMG 853
Placebo
Arm Description
Outcomes
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.
Secondary Outcome Measures
Evaluate the efficacy of AMG 853 as measured by use of rescue short-acting β-agonist (SABA)
Evaluate the efficacy of AMG 853 as measured by daily symptom score (aggregate/night and individual symptoms; and symptom free days)
Evaluate the efficacy of AMG 853 as measured by pre- and post-bronchodilator forced expiratory volume in 1 second (FEV1)
Evaluate the efficacy of AMG 853 as measured by AM and PM peak expiratory flow rate (PEFR)
Evaluate the efficacy of AMG 853 as measured by asthma quality of life questionnaire (AQLQ)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01018550
Brief Title
AMG 853 Phase 2 Study in Subjects With Inadequately Controlled Asthma
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
Study Type
Interventional
2. Study Status
Record Verification Date
February 2016
Overall Recruitment Status
Completed
Study Start Date
October 2009 (undefined)
Primary Completion Date
December 2010 (Actual)
Study Completion Date
March 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Amgen
4. Oversight
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
397 (Actual)
8. Arms, Groups, and Interventions
Arm Title
AMG 853
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
AMG 853
Intervention Description
AMG 853 5 mg (BID)
Intervention Type
Drug
Intervention Name(s)
AMG 853
Intervention Description
AMG 853 200 mg (QD)
Intervention Type
Drug
Intervention Name(s)
AMG 853
Intervention Description
AMG 853 25 mg (BID)
Intervention Type
Drug
Intervention Name(s)
AMG 853
Intervention Description
AMG 853 100 mg (BID)
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo
Primary Outcome Measure Information:
Title
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 Outcome Measure Information:
Title
Evaluate the efficacy of AMG 853 as measured by use of rescue short-acting β-agonist (SABA)
Time Frame
Baseline to Week 12
Title
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
Title
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
Title
Evaluate the efficacy of AMG 853 as measured by AM and PM peak expiratory flow rate (PEFR)
Time Frame
Baseline to Week 12
Title
Evaluate the efficacy of AMG 853 as measured by asthma quality of life questionnaire (AQLQ)
Time Frame
Baseline to Week 12
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
MD
Organizational Affiliation
Amgen
Official's Role
Study Director
12. IPD Sharing Statement
Citations:
PubMed Identifier
23174659
Citation
Busse WW, Wenzel SE, Meltzer EO, Kerwin EM, Liu MC, Zhang N, Chon Y, Budelsky AL, Lin J, Lin SL. Safety and efficacy of the prostaglandin D2 receptor antagonist AMG 853 in asthmatic patients. J Allergy Clin Immunol. 2013 Feb;131(2):339-45. doi: 10.1016/j.jaci.2012.10.013. Epub 2012 Nov 20.
Results Reference
background
Links:
URL
http://www.amgentrials.com
Description
AmgenTrials clinical trials website
Learn more about this trial
AMG 853 Phase 2 Study in Subjects With Inadequately Controlled Asthma
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