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
Results First Posted : August 14, 2020
Last Update Posted : August 14, 2020
|Condition or disease||Intervention/treatment||Phase|
|Chronic Spontaneous Urticaria||Biological: Ligelizumab||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|
QGE031 240 mg s.c. q4w x 13 treatments
QGE031 240 mg s.c. q4w
Other Name: QGE031
- Number of Participants With at Least One Treatment Emergent Adverse Event (AE) [ Time Frame: Within 16 weeks after Week 48 ]The primary objective of this study was to assess the long-term safety of one-year treatment of QGE031 in adult Chronic Spontaneous Urticaria (CSU) patients who completed the core study CQGE031C2201 using the following evaluations: number of participants with treatment emergent AEs of non-serious and serious nature including any events of special interest.
- Percentage of Subjects Having Achieved UAS7 ≤ 6 [ Time Frame: Baseline, Week 52 and Week 100 ]
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 (Urticaria Activity Score) UAS7 ≤ 6 over 48 weeks post-treatment follow up epoch among the participants achieving remission at the end of treatment epoch.
- Number and Proportion of Participants Who Achieved UAS7≤ 6 [ Time Frame: Baseline, Week 52, Week 100 ]Summary of subjects with UAS7 ≤ 6. The long term efficacy of one-year treatment of ligelizumab 240 mg s.c. q4w is assessed by number and proportion of participants who achieved well controlled disease (UAS7≤ 6) at end of the treatment period (Week 52) and end of follow up period (Week 100).
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