Bilastine Updosing in Chronic Spontaneous Urticaria
August 25, 2016 updated by: K. Weller, Charite University, Berlin, Germany
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.
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
30
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Berlin, Germany, 10117
- Dpt. of Dermatology and Allergy
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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).
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: 20 mg Bilastin
20mg Bilastine once daily
|
20mg (8 weeks)
Other Names:
40mg
Other Names:
80mg
Other Names:
|
|
Active Comparator: Bilastin 40mg
40 mg Bilastine once daily, intake of two tablets 20mg Bilastine
|
20mg (8 weeks)
Other Names:
40mg
Other Names:
80mg
Other Names:
|
|
Active Comparator: Bilastin 80mg
80 mg Bilastine once daily, intake of four tablets 20mg Bilastine
|
20mg (8 weeks)
Other Names:
40mg
Other Names:
80mg
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
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
|
8 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
Time Frame: 4 weeks
|
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 |
4 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Karsten Weller, MD, Dpt. of Dermatology and Allergy , Charité
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2014
Primary Completion (Actual)
March 1, 2016
Study Completion (Actual)
March 1, 2016
Study Registration Dates
First Submitted
August 8, 2014
First Submitted That Met QC Criteria
August 8, 2014
First Posted (Estimate)
August 11, 2014
Study Record Updates
Last Update Posted (Estimate)
August 26, 2016
Last Update Submitted That Met QC Criteria
August 25, 2016
Last Verified
August 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- BUCSU
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