A Safety Extension Study to Evaluate the Long-term Safety of QGE031 in Chronic Spontaneous Urticaria (CSU) Patients
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|ClinicalTrials.gov Identifier: NCT02649218|
Recruitment Status : Completed
First Posted : January 7, 2016
Last Update Posted : October 16, 2019
|Condition or disease||Intervention/treatment||Phase|
|Chronic Spontaneous Urticaria||Biological: QGE031||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||227 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||An Open Label, Multicenter, Extension Study to Evaluate the Long-term Safety of QGE031 240 mg s.c. Given Every 4 Weeks for 52 Weeks in Chronic Spontaneous Urticaria Patients Who Completed Study CQGE031C2201|
|Actual Study Start Date :||May 24, 2016|
|Actual Primary Completion Date :||May 2, 2019|
|Actual Study Completion Date :||May 2, 2019|
Experimental: Arm 1
QGE031 every 4 weeks x 13 treatments
- Number of participants with treatment-emergent adverse events (AEs) [ Time Frame: 2 years ]The primary objective of this study was to assess the long-term safety of QGE031 in adult Chronic Spontaneous Urticaria (CSU) patients who completed the core study CQGE031C2201 using the following evaluations: number of participants with AEs of non-serious and serious adverse events including any events of special interest.
- Number of participants with sustained remission [ Time Frame: 2 years ]
The secondary objective of this study was to assess the long-term efficacy of QGE031 in adult CSU patients who completed the CQGE031C2201 study using the following evaluations:
Sustained remission defined as maintaining UAS7 ≤ 6 over 48 weeks post-treatment follow up epoch among the participants achieving remission at the end of treatment epoch.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02649218