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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
omalizumab 300 mg every four weeks
DrugContinue standard treatment with omalizumab 300 mg every four weeks from week 12 to week 36. Both arms are treated with omalizumab 300 mg from week 0 to week 12.
omalizumab 300 mg every six weeks
DrugTreatment in an extended interval of omalizumab 300 mg every six weeks from week 12 to week 36. Both arms are treated with omalizumab 300 mg from week 0 to week 12.
Treatment groups
40 Participants
are divided into 2 treatment groupsGroup A: omalizumab 300 mg every six weeksActive comparator 1 intervention
Group B: omalizumab 300 mg every four weeksActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Absolute difference in average Urticaria Control Test (UCT) score at week 36
The Urticaria Control Test (UCT) is a retrospective questionnaire that gathers information regarding the past 4 weeks. It consists of four questions, each with four possible answer options. A score ranging from 0 to 4 is assigned to each answer option. Consequently, the UCT score ranges from 0 to 16, with higher scores indicating lower control of the disease. A UCT score of 12 or higher suggests well-controlled urticaria, while a score of 16 indicates complete control.
Time frame
Through study completion, an average of 36 weeksSecondary outcomes
1
Absolute difference in average Urticaria Control Test (UCT) score at week 24
The Urticaria Control Test (UCT) is a retrospective questionnaire that gathers information regarding the past 4 weeks. It consists of four questions, each with four possible answer options. A score ranging from 0 to 4 is assigned to each answer option. Consequently, the UCT score ranges from 0 to 16, with higher scores indicating lower control of the disease. A UCT score of 12 or higher suggests well-controlled urticaria, while a score of 16 indicates complete control.
Time frame
Through study completion, an average of 36 weeks2
Proportion of well-controlled patients (UCT score ≥ 12) at week 24 and 36
The Urticaria Control Test (UCT) is a retrospective questionnaire that gathers information regarding the past 4 weeks. It consists of four questions, each with four possible answer options. A score ranging from 0 to 4 is assigned to each answer option. Consequently, the UCT score ranges from 0 to 16, with higher scores indicating lower control of the disease. A UCT score of 12 or higher suggests well-controlled urticaria, while a score of 16 indicates complete control.
Time frame
Through study completion, an average of 36 weeks3
Proportion of completely controlled patients (UCT score = 16) at week 24 and 36
The Urticaria Control Test (UCT) is a retrospective questionnaire that gathers information regarding the past 4 weeks. It consists of four questions, each with four possible answer options. A score ranging from 0 to 4 is assigned to each answer option. Consequently, the UCT score ranges from 0 to 16, with higher scores indicating lower control of the disease. A UCT score of 12 or higher suggests well-controlled urticaria, while a score of 16 indicates complete control.
Time frame
Through study completion, an average of 36 weeks4
Difference in absolute UCT score measured as area under the curve (AUC)
The Urticaria Control Test (UCT) is a retrospective questionnaire that gathers information regarding the past 4 weeks. It consists of four questions, each with four possible answer options. A score ranging from 0 to 4 is assigned to each answer option. Consequently, the UCT score ranges from 0 to 16, with higher scores indicating lower control of the disease. A UCT score of 12 or higher suggests well-controlled urticaria, while a score of 16 indicates complete control.
Time frame
Through study completion, an average of 36 weeksSponsors and contacts
Click on the lead sponsor to view all of their trials.
Simon Francis Thomsen
Lead sponsor
Bispebjerg Hospital
Sponsor institution
Aarhus University Hospital
Collaborator
Source ClinicalTrials.gov