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

Inclusion Criteria:

- Patients eligible for inclusion in this study have to fulfill all of the following
criteria:

1. Written informed consent must be obtained before any assessment is performed.

2. 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.

3. 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).

4. 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