AMG 853 Phase 2 Study in Subjects With Inadequately Controlled Asthma

Phase 2

Completed

• Conditions: Asthma
• Interventions: Drug: Placebo; Drug: AMG 853

• Registration Number: NCT01018550
• Lead Sponsor: Amgen

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-10
• Study First Submitted: 2009-11-19
• Study First Submitted QC: 2009-11-19
• Study First Posted: 2009-11-23
• Primary Completion: 2010-12
• Study Completion: 2011-03
• Status Verified: 2016-02
• Disposition First Submitted: 2016-02-23
• Disposition First Submitted QC: 2016-02-23
• Last Update Submitted: 2016-02-23
• Disposition First Posted: 2016-03-23
• Last Update Posted: 2016-03-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 397

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	-
AMG 853	AMG 853	-

Primary Outcome Measures

Name	Time	Method
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.	Baseline to Week 12

Secondary Outcome Measures

Name	Time	Method
Evaluate the efficacy of AMG 853 as measured by AM and PM peak expiratory flow rate (PEFR)	Baseline to Week 12
Evaluate the efficacy of AMG 853 as measured by daily symptom score (aggregate/night and individual symptoms; and symptom free days)	Baseline to Week 12
Evaluate the efficacy of AMG 853 as measured by pre- and post-bronchodilator forced expiratory volume in 1 second (FEV1)	Baseline to Week 12
Evaluate the efficacy of AMG 853 as measured by use of rescue short-acting β-agonist (SABA)	Baseline to Week 12
Evaluate the efficacy of AMG 853 as measured by asthma quality of life questionnaire (AQLQ)	Baseline to Week 12