NCT00500539

Open Label Study to Assess Safety and Immunogenicity of Omalizumab Liquid Formulation.

An Open Label, Single Arm Study to Assess the Safety and Immunogenicity of Omalizumab Liquid Administered Subcutaneously to Male and Female Adolescents and Adults With Persistent Allergic Asthma

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 155 (actual)
• Sponsor: Novartis · Industry
• Sex: All
• Age: 12 Years
• Healthy volunteers: Not accepted

Summary

The primary objective of this study is to assess the immunogenic potential of the liquid formulation of omalizumab administered over a period of 6 months in moderate to severe persistent allergic asthma patients 12 years of age or older, with no previous exposure to the drug (omalizumab naïve patients). The secondary objective of this study is to assess the safety of the liquid formulation of omalizumab in the same patients.

Conditions

• Asthma

Interventions

Type	Name	Description
DRUG	omalizumab	The liquid formulation of omalizumab was packaged in a pre-filled safety syringe containing either 75 mg (0.5ml) or 150 mg (1.0 ml) of drug. The syringes were clearly marked so that the health care provider could differentiate between the 75 mg or 150 mg syringe.

Timeline

• Start date: 2007-07-01
• Primary completion: 2008-09-01
• Completion: 2008-09-01
• First posted: 2007-07-12
• Last updated: 2011-06-02
• Results posted: 2011-04-27

Locations

31 sites across 3 countries: United States, Argentina, Germany