Extending Omalizumab Treatment Intervals in Patients With Chronic Spontaneous Urticaria
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorSimon Francis Thomsen
About this trial
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.
Eligibility criteria
Qualifiers
A diagnosis of CSU according to the EAACI/GA2LEN/EDF/WAO guidelines.
Age ≥ 18 years.
Omalizumab-naïve prior to initiating treatment with omalizumab.
Background treatment with four antihistamines daily.
Disqualifiers
Pregnant or breastfeeding women.
Planned pregnancy within the next 6 months.
Weight ≥ 100 kilograms.
Presence of any other active skin disease or condition that may interfere with the assessment of CSU, such as atopic dermatitis, bullous pemphigoid, senile pruritus, or psoriasis.
Trial design
Treatments tested in this trial
- omalizumab 300 mg every four weeks
- omalizumab 300 mg every six weeks
Treatment groups
40 Participants
are divided into 2 treatment groupsSponsors and collaborators
Simon Francis Thomsen
Lead sponsor
Bispebjerg Hospital
Sponsor institution
Aarhus University Hospital
Collaborator
Source ClinicalTrials.gov