Actively Recruiting
Extending Omalizumab Treatment Intervals in Patients With Chronic Spontaneous Urticaria
Led by Simon Francis Thomsen · Updated on 2025-09-19
40
Participants Needed
1
Research Sites
102 weeks
Total Duration
On this page
Sponsors
S
Simon Francis Thomsen
Lead Sponsor
A
Aarhus University Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
This study is a multicentre, randomized, open-label, non-inferiority clinical trial. The purpose and aim of this study is to investigate if patients with well controlled (UCT score score ≥ 12) chronic spontaneous urticaria (CSU) on omalizumab 300 mg every four weeks can extend treatment intervals and maintain disease control.
CONDITIONS
Official Title
Extending Omalizumab Treatment Intervals in Patients With Chronic Spontaneous Urticaria
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosed with chronic spontaneous urticaria (CSU) according to EAACI/GA2LEN/EDF/WAO guidelines
- Age 18 years or older
- No prior treatment with omalizumab before starting this study
- On a background treatment of four antihistamines daily
- Eligible for omalizumab treatment based on Danish guidelines
You will not qualify if you...
- Pregnant or breastfeeding women
- Planning to become pregnant within the next 6 months
- Weight 100 kilograms or more
- Having other active skin diseases that interfere with CSU assessment, such as atopic dermatitis, bullous pemphigoid, senile pruritus, or psoriasis
- Using immunosuppressive drugs like prednisolone, azathioprine, methotrexate, or cyclosporine
- Mainly experiencing symptoms from chronic inducible urticaria (CIndU)
- Unable to complete or comply with study procedures
- Positive basophil histamine release assay (BHRA) test
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Department of Dermatology, Bispebjerg Hospital
Copenhagen, Copenhagen N, Denmark, 2100
Actively Recruiting
Research Team
S
Simon F Thomsen, MD, DMSc
CONTACT
D
Ditte G Zhang, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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