Bilastine Updosing in Chronic Spontaneous Urticaria
Primary Purpose
Chronic Urticaria
Status
Completed
Phase
Phase 3
Locations
Germany
Study Type
Interventional
Intervention
Bilastine
Bilastine
Bilastin
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Urticaria
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).
Sites / Locations
- Dpt. of Dermatology and Allergy
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
Active Comparator
Arm Label
20 mg Bilastin
Bilastin 40mg
Bilastin 80mg
Arm Description
20mg Bilastine once daily
40 mg Bilastine once daily, intake of two tablets 20mg Bilastine
80 mg Bilastine once daily, intake of four tablets 20mg Bilastine
Outcomes
Primary Outcome Measures
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 Outcome Measures
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
Full Information
NCT ID
NCT02213367
First Posted
August 8, 2014
Last Updated
August 25, 2016
Sponsor
Charite University, Berlin, Germany
1. Study Identification
Unique Protocol Identification Number
NCT02213367
Brief Title
Bilastine Updosing in Chronic Spontaneous Urticaria
Official Title
Phase 3 Study, Exploratory, Disease Activity Controlled Dose Escalating Study to Assess the Efficacy, and Safety of Treatment With Bilastine 20 mg, 40 mg and 80 mg in Chronic Spontaneous Urticaria.
Study Type
Interventional
2. Study Status
Record Verification Date
August 2016
Overall Recruitment Status
Completed
Study Start Date
July 2014 (undefined)
Primary Completion Date
March 2016 (Actual)
Study Completion Date
March 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Charite University, Berlin, Germany
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Chronic spontaneous urticaria (CSU), formerly also known as chronic idiopathic urticaria and chronic urticaria (CU), is one of the most frequent skin diseases. At any time, 0.5-1% of the population suffers from the disease. Although all age groups can be affected, the peak incidence is seen between 20 and 40 years of age. The duration of the disease is generally several years but is likely to be longer in more severe cases, cases with concurrent angioedema, in combination with physical urticaria or with a positive autologous serum skin test (autoreactivity). CSU has major detrimental effects on quality of life, with sleep deprivation and psychiatric comorbidity being frequent. It also has a large impact on society in terms of direct and indirect health care costs as well as reduced performance at work and in private life.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Urticaria
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
20 mg Bilastin
Arm Type
Active Comparator
Arm Description
20mg Bilastine once daily
Arm Title
Bilastin 40mg
Arm Type
Active Comparator
Arm Description
40 mg Bilastine once daily, intake of two tablets 20mg Bilastine
Arm Title
Bilastin 80mg
Arm Type
Active Comparator
Arm Description
80 mg Bilastine once daily, intake of four tablets 20mg Bilastine
Intervention Type
Drug
Intervention Name(s)
Bilastine
Other Intervention Name(s)
Bilaxten
Intervention Description
20mg (8 weeks)
Intervention Type
Drug
Intervention Name(s)
Bilastine
Other Intervention Name(s)
Bilaxten
Intervention Description
40mg
Intervention Type
Drug
Intervention Name(s)
Bilastin
Other Intervention Name(s)
Bilaxten
Intervention Description
80mg
Primary Outcome Measure Information:
Title
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.
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
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.
Description
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
Time Frame
4 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Karsten Weller, MD
Organizational Affiliation
Dpt. of Dermatology and Allergy , Charité
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dpt. of Dermatology and Allergy
City
Berlin
ZIP/Postal Code
10117
Country
Germany
12. IPD Sharing Statement
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Bilastine Updosing in Chronic Spontaneous Urticaria
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