A Safety Extension Study to Evaluate the Long-term Safety of QGE031 in Chronic Spontaneous Urticaria (CSU) Patients

Study Overview
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Brief Summary
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A safety 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 (CSU) patients who completed study CQGE031C2201

Detailed Description
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A safety extension study to evaluate the long-term safety of QGE031 in Chronic Spontaneous Urticaria patients

Official Title
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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

Conditions
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Chronic Spontaneous Urticaria

Intervention / Treatment
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* Biological: Ligelizumab


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients eligible for inclusion in this study have to fulfill all of the following criteria: Written informed consent must be obtained before any assessment is performed. Patients who complete the treatment epoch in study CQGE031C2201 and complete at least Visit 203 (Week 32 of the follow-up epoch, ≥16 weeks after last injection) and present with active disease as defined by UAS7 ≥12. Patients must not have any missing eDiary entries in the 7 days prior to Visit 301 (patients are allowed to repeat until this criterion is met). Willing and able to complete a daily symptom eDiary for the duration of the study and adhere to the study visit schedules. Exclusion Criteria: Clearly defined underlying etiology for chronic urticaria other than chronic spontaneous urticaria Evidence of parasitic infection Any other skin diseases than chronic spontaneous urticaria with chronic itching Contraindications to or hypersensitivity to fexofenadine, loratadine, cetirizine, or epinephrine History of anaphylaxis History or current diagnosis of ECG abnormalities indicating significant risk of safety for patients participating in the study History of hypersensitivity to any of the study drugs or its components of similar chemical classes Pregnant or nursing (lactating) women Other protocol-defined inclusion/exclusion criteria may apply

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ligelizumab<br>QGE031 240 mg s.c. q4w x 13 treatments | Biological: Ligelizumab<br>* QGE031 240 mg s.c. q4w<br>* Other names: QGE031;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With at Least One Treatment Emergent Adverse Event (AE) | 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. | Within 16 weeks after Week 48 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Subjects Having Achieved UAS7 ≤ 6 | 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. | Baseline, Week 52 and Week 100 | 
| Number and Proportion of Participants Who Achieved UAS7≤ 6 | 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). | Baseline, Week 52, Week 100 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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adults, CSU, QGE031, chronic, spontaneous, Urticaria, Safety, ligelizumab