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

• Status: Completed
• Trial end date: 2011-12-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Amgen
• Treatments: Antibodies, Monoclonal; Brodalumab

Criteria

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)