Bilastine Updosing in Chronic Spontaneous Urticaria

Launched by CHARITE UNIVERSITY, BERLIN, GERMANY · Aug 8, 2014

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Eligibility criteria

• Inclusion Criteria:
• • Male or female aged 18 years and older
• • History of active chronic spontaneous urticaria with or without associated angioedema for at least three days per week over the last 6 weeks prior to visit 1. - Urticaria symptoms 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 with study procedures
• • Willing, committed and able to return for all clinic visits and complete all study-related procedures
• • In females of childbearing potential: negative pregnancy test; females willing to use highly effective contraception (Pearl-Index \< 1) a woman will be considered not of childbearing 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 in this study
• Exclusion Criteria:
• • Chronic spontaneous urticaria patients with a known resistance to bilastine
• • Isolated presence or domination of inducible forms of urticaria or cholinergic urticaria (no chronic spontaneous urticaria)
• • History of adverse reactions to bilastine or known hypersensitivity to bilastine or its ingredients
• • Intake of oral corticosteroids or intravenously applied corticosteroids within 28 days prior to screening visit
• • Use of depot corticosteroids within 3 months prior to screening visit (inhaled corticosteroids 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 the patient immunocompromised or not suitable for a clinical trial
• • Significant concomitant illness, in the opinion of the Investigator, that would adversely affect the subject's participation or evaluation in this study
• • ECG alterations of repolarisation (QTc prolongations \>450ms or increase of QTc \>60ms as 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 the upper reference value, serum creatinine 1.5 times above the upper reference value)
• • Subjects for whom there is concern, in the opinion of the Investigator, about compliance with the protocol procedures
• • The presence of a permanent gastrointestinal condition which may influence the oral therapy (chronic diarrhoea diseases, congenital malformations or surgical mutilations of 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).