drugset / Trial / NCT01125748

A Study Evaluating the Persistency of Response With or Without Xolair (Omalizumab) After Long-term Therapy

NCT01125748 ↗

Phase 4 Completed 176 enrolled Genentech, Inc.
RandomizedParallel-groupDouble-blindTreatment

Summary

This was a randomized, double-blind, placebo-controlled, 2-arm, 1-year study of participants who completed the EXCELS study (NCT00252135) and had received long-term treatment with Xolair. In addition, participants who did not participate in the EXCELS study but received long-term (\~5 years) treatment with Xolair were allowed to enter the study.

Timeline

Start
2010-05
Primary completion
2013-08
Completion
2013-08

Outcome

Met primary endpoint

registry Mean Difference (Final Values) 19.3 (95% CI 5.0 to 33.6) NCT01125748 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Omalizumab Monoclonal antibody — Subcutaneous
Background Prednisone Other / unclassified — Oral
Background Zafirlukast Small molecule — —
Background Zileuton Small molecule — —

Indications