Chronic Spontaneous Urticaria MedDRA version: 17.0 Level: PT Classification code 10072757 Term: Chronic spontaneous urticaria System Organ Class: 10040785 - Skin and subcutaneous tissue disorders
Conditions
Interventions
Trade Name: Bitosen
Product Name: Bilastine
Pharmaceutical Form: Tablet
Sponsors
Charite - Universitätsmedizin Berlin
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Male or female aged 18 years and older - History of active csU (urticaria wheals) 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 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 Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 20 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 10
Exclusion criteria
Exclusion criteria: - Chronic spontaneous urticaria patients with a known resistance to bilastine in standard (licensed) dose - 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 - 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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the effects of standard dose (20 mg) and higher than standard dose of bilastine (40 mg and 80 mg) on disease activity in patients with chronic spontaneous urticaria.;Secondary Objective: - To assess the effects of standard dose (20 mg) and higher than standard dose of bilastine (40 mg and 80 mg) on quality of life impairment in patients with chronic spontaneous urticaria. - To assess the safety of bilastine in doses of 20 mg, 40 mg and 80 mg in chronic spontaneous urticaria patients by documentation of adverse events. - To assess the effects of standard dose (20 mg) and higher than standard dose of bilastine (40 mg and 80 mg) on biomarkers of chronic spontaneous urticaria, such as substance P and D-Dimers ;Primary end point(s): Comparison of the rate of complete responders (reduction of the UAS7 by at least 90% (as compared to baseline) or a UAS7 = 3) between the second (20 mg bilastine), fourth (20 mg or 40 mg bilastine) and sixth week (20 mg, 40 mg or 80 mg bilastine) of the treatment phase.;Timepoint(s) of evaluation of this end point: In the second, fourth and sixth week of the treatment phase. | — |
Secondary
| Measure | Time frame |
|---|---|
| Timepoint(s) of evaluation of this end point: Depends on the end point. See above.;Secondary end point(s): - Comparison of additional responder rates between the second (20 mg bilastine), fourth (20 mg or 40 mg bilastine) and sixth week (20 mg, 40 mg or 80 mg bilastine) of the treatment phase. - Comparison of the quality of life changes (based on the CU-Q2OL) between baseline, the first/second (20 mg bilastine), third/fourth (20 mg or 40 mg bilastine) and fifth/sixth week (20 mg, 40 mg or 80 mg bilastine) of the treatment phase. - Description and comparison of the type and frequency of adverse events during treatment with bilastine 20 mg, 40 mg and 80 mg. - Comparison of biomarker levels during no treatment and treatment with bilastine 20 mg, 40 mg and 80 mg. | — |
Countries
Germany
Contacts
Public ContactAllergie-Centrum-Charite
Charite - Universitätsmedizin Berlin
Outcome results
None listed