NCT01155700

Pharmacokinetics and Pharmacodynamics, Efficacy and Safety of Omalizumab in Japanese Children (6 - 15 Years)

A 24 Week, Open Label, Multi-center Evaluation of Pharmacokinetics and Pharmacodynamics, Efficacy and Safety of Omalizumab in Japanese Children (6 - 15 Years) With Inadequately Controlled Allergic Asthma Despite Current Recommended Treatment

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 51 (actual)
• Sponsor: Novartis Pharmaceuticals · Industry
• Sex: All
• Age: 6 Years – 15 Years
• Healthy volunteers: Not accepted

Summary

The primary purpose of this study is to examine whether the geometric mean of serum free IgE level at 24 weeks of the treatment period in Japanese pediatric patients (6 to 15 years of age) reaches under 25 ng/mL (target level). The investigators will also assess how well PK/PD data of Japanese children fit the global PK-PD modeling built from those of Caucasian adults and children, and assess efficacy and safety data in Japanese pediatric patients which will fulfill the Japanese health authority requirement for approval. Data obtained from the study is intended to be used to support the registration of pediatric indication of omalizumab in Japan.

Conditions

• Allergic Asthma

Interventions

Type	Name	Description
DRUG	omalizumab

Timeline

• Start date: 2010-06-01
• Primary completion: 2012-02-01
• Completion: 2012-02-01
• First posted: 2010-07-02
• Last updated: 2016-11-18

Locations

17 sites across 1 country: Japan