Bilastine Updosing in Chronic Spontaneous Urticaria

Inclusion Criteria:

• Male or female aged 18 years and older

• History of active chronic spontaneous urticaria with or without associated angioedemafor at least three days per week over the last 6 weeks prior to visit 1. - Urticariasymptoms must comprise wheals and itch

• History of failed treatment with an antihistamine other than bilastine in standard (licensed) dose.

• UAS7 of ≥14 during baseline

• Informed consent signed and dated

• Able to read, understand and willing to sign the informed consent form and abide withstudy procedures

• Willing, committed and able to return for all clinic visits and complete allstudy-related procedures

• In females of childbearing potential: negative pregnancy test; females willing to usehighly effective contraception (Pearl-Index < 1) a woman will be considered not ofchildbearing potential if she is post-menopausal for > 2 years or surgically sterile (bilateral tubal ligation, bilateral oophorectomy or hysterectomy)

• No participation in other clinical trials 4 weeks before and after participation inthis study

Exclusion Criteria:

• Chronic spontaneous urticaria patients with a known resistance to bilastine

• Isolated presence or domination of inducible forms of urticaria or cholinergicurticaria (no chronic spontaneous urticaria)

• History of adverse reactions to bilastine or known hypersensitivity to bilastine orits ingredients

• Intake of oral corticosteroids or intravenously applied corticosteroids within 28 daysprior to screening visit

• Use of depot corticosteroids within 3 months prior to screening visit (inhaledcorticosteroids are allowed)

• Use of systemic immunosupressants/immunomodulators such as ciclosporin, dapsone,metotrexate, and comparable drugs within 28 days prior to screening visit.

• Use of UV-therapy within 28 days prior to visit 1

• Significant medical condition, in the opinion of the Investigator, rendering thepatient immunocompromised or not suitable for a clinical trial

• Significant concomitant illness, in the opinion of the Investigator, that wouldadversely affect the subject's participation or evaluation in this study

• ECG alterations of repolarisation (QTc prolongations >450ms or increase of QTc >60msas compared to the baseline assessment)

• Blood pressure >180/100 mmHg and/or heart rate >100/min

• Evidence of significant hepatic or renal disease (GOT and/or GPT >2 times above theupper reference value, serum creatinine 1.5 times above the upper reference value)

• Subjects for whom there is concern, in the opinion of the Investigator, aboutcompliance with the protocol procedures

• The presence of a permanent gastrointestinal condition which may influence the oraltherapy (chronic diarrhoea diseases, congenital malformations or surgical mutilationsof gastrointestinal tract)

• Presence of active cancer which requires chemotherapy or radiation therapy

• Presence of alcohol abuse or drug addiction

• Pregnancy or breast-feeding

• Subjects who are inmates of psychiatric wards, prisons, or other state institutions.Existing or planned placement in an institution after ruling according to § 40 passage 1, number 4 AMG (Arzneimittelgesetz).