Extending omalizumab treatment intervals in patients with chronic spontaneous urticaria (EXOTIC trial)
- Conditions
- Chronic spontaneous urticariaTherapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
- Registration Number
- CTIS2023-506187-14-00
- Lead Sponsor
- Bispebjerg Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 40
A diagnosis of CSU according to the EAACI/GA2LEN/EDF/WAO guidelines, Age = 18 years, A UCT score = 12 at week 12 after initiating treatment with 300 mg omalizumab every four weeks., Omalizumab naïve prior to initiating treatment with omalizumab., Background treatment of 4 antihistamines daily, Type 1 CSU (negative BHRA), Candidate for omalizumab treatment according to Danish practice
Pregnant or breastfeeding women, Planned pregnancy within 6 months, Body mass index (BMI) = 100 kilograms, Any other active skin disease or condition that may interfere with assessment of CSU e.g., atopic dermatitis, bullous pemphigoid, senile pruritus, or psoriasis., Use of immunosuppressive drugs e.g., prednisolone, azathioprine, methotrexate, and cyclosporine., Predominantly symptoms from chronic inducible urticaria (CIndU), Positive BHRA, Inability to complete study or comply with study procedures
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method