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Clinical Trial Summary

The purpose of this study was to evaluate the safety and efficacy of ligelizumab in adult Japanese subjects with CSU, who remain symptomatic despite treatment with H1-antihistamines (AHs) at locally approved doses. The study population consisted of 66 male and female subjects aged ≥ 18 years who were diagnosed with CSU and who remained symptomatic despite the use of H1-AH. This was a Phase III multi-center, open-label, single arm study. There was a screening period of up to 28 days, a 52 week treatment period, and a 12 week post-treatment follow-up period.


Clinical Trial Description

This was a Phase III multi-center, open-label, single arm study. The study consisted of 3 distinct periods: Screening period (Day -28 to Day -14): Subjects who gave informed consent were assessed for eligibility during this period which lasted for up to 4 weeks. Treatment period (52 weeks): Subjects had site visits every 4 weeks during this period to receive study drug and complete on-site assessments. Post-treatment follow-up period (12 weeks): Subject had site visits every 4 weeks with the final visit occurring 16 weeks after the last treatment dose. No study treatment was given during the period. This study was designed to obtain safety data of QGE031 in 66 Japanese CSU patients. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03907878
Study type Interventional
Source Novartis
Contact
Status Completed
Phase Phase 3
Start date April 13, 2019
Completion date January 26, 2022

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