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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Amgen
ClinicalTrials.gov Identifier:
NCT01199289
First received: August 5, 2010
Last updated: May 31, 2013
Last verified: May 2013

August 5, 2010
May 31, 2013
October 2010
December 2011   (final data collection date for primary outcome measure)
The primary objective is to determine if AMG 827 is effective compared to placebo as mesasured by change in Asthma Control Questionnaire (ACQ) composite scores from baseline to week 12. [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
The primary objective is to determine if AMG 827 is effective compared to placebo as mesasured by change in Asthma Control Questionnaire (ACQ) composite scores from baseline to week 12. [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01199289 on ClinicalTrials.gov Archive Site
  • Evaluate the efficacy of AMG 827 as measured by Pre- and post-bronchodilator FEV1 (forced expiratory volume in 1 second) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Evaluate the efficacy of AMG 827 as measured by am and pm Peak expiratory flow rate (PEFR) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Evaluate the efficacy of AMG 827 as measured by use of rescue Short Acting β-Agonist (SABA) use [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Evaluate the efficacy of AMG 827 as measured by daily asthma symptoms (aggregate/night and individual) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Evaluate the efficacy of AMG 827 as measured by Asthma Quality of Life Questionnaire (AQLQ) score [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
A Study to Evaluate the Dosing of AMG 827 for Subjects With Inadequately Controlled Asthma
A Randomized, Double-Blind, Placebo-Controlled Phase 2 Study to Determine the Safety and Efficacy of AMG 827 in Subjects With Inadequately Controlled Asthma

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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Asthma
  • Drug: AMG 827
    210 mg AMG 827 SC
  • Drug: Placebo
    Placebo SC
  • Drug: AMG 827
    140 mg AMG 827 SC
  • Drug: AMG 827
    280 mg AMG 827 SC
  • Experimental: AMG 827 280 mg
    280 mg AMG 827
    Intervention: Drug: AMG 827
  • Placebo Comparator: Placebo
    Placebo
    Intervention: Drug: Placebo
  • Experimental: AMG 827 140 mg
    140 mg AMG 827
    Intervention: Drug: AMG 827
  • Experimental: AMG 827 210 mg
    210 mg AMG 827
    Intervention: Drug: AMG 827
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
315
December 2011
December 2011   (final data collection date for primary outcome measure)

Inclusion Criteria:

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

Exclusion Criteria:

  • 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)
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
Austria,   United States,   Russian Federation,   Belgium,   Canada,   Finland,   Hungary,   Korea, Republic of,   Netherlands,   Poland
 
NCT01199289
20090203
No
Amgen
Amgen
Not Provided
Study Director: MD Amgen
Amgen
May 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP