Safety, Tolerability, and Pharmacokinetics of AMG 827 in Adolescents With Asthma

• Status: Withdrawn
• Trial end date: 2012-06-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics in adolescent and adult subjects with intermittent or mild to moderate persistent asthma.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Amgen
• Treatments: Brodalumab

Criteria

Inclusion Criteria:

• Male and/or female subjects 12 to < 18 years of age at the time of randomization

• Male and/or female subjects between 18 and 50 years of age (inclusive) at the time of randomization

• Body weight ≥ 36 kg at screening

• Intermittent or mild to moderate persistent asthma for at least the past 3 months prior to study enrollment (as defined by the 2004 Global Initiative for Asthma [GINA] guidelines.

Exclusion Criteria:

• Experienced an asthma exacerbation (defined as a disease episode resulting in treatment in an emergency room or urgent care facility, or an episode treated with oral corticosteroids) during the 3 months prior to study enrollment.

• Hospitalized for asthma during the 6 months prior to study enrollment; or ever intubated for the treatment of asthma.

• Use of oral corticosteroids within 3 months prior to study enrollment.