Clinical trial NCT05916937: Extending Omalizumab Treatment Intervals in Patients with Chronic Spontaneous Urticaria
Official title: Extending Omalizumab Treatment Intervals in Patients with Chronic Spontaneous Urticaria (EXOTIC Trial): a Multicentre, Randomized, Open-label, Non-inferiority Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Chronic Spontaneous Urticaria
Chronic Urticaria, Idiopathic
Lead sponsor: Bispebjerg Hospital
Sponsor class: OTHER
Collaborators: name: Aarhus University Hospital
First posted: 2023-06-23
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Multicenter, randomized, open-label, non-inferiority trial.
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: Newly referred patients with CSU who are well-treated (UCT score ≥ 12) 12 weeks after initiating standard treatment with omalizumab 300 mg every four weeks, are randomized into two treatment arms.The first arm will continue standard treatment with omalizumab 300 mg every four weeks for 24 weeks. The second arm will receive treatment in an extended interval of omalizumab 300 mg every six weeks for 24 weeks.

Eligibility criteria: Inclusion Criteria:

* 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.
* Candidate for omalizumab treatment according to Danish guidelines.

Exclusion Criteria:

* 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.
* Use of immunosuppressive drugs, such as prednisolone, azathioprine, methotrexate, or cyclosporine.
* Predominantly experience symptoms from chronic inducible urticaria (CIndU).
* Inability to complete study or comply with study procedures.

Patients with a positive basophil histamine release assay (BHRA) are not eligible for the study. Patients may therefore be withdrawn from the trial after enrolment, if they are found to have a positive BHRA test in the initial blood work.

Primary outcomes:
measure: Absolute difference in average Urticaria Control Test (UCT) score at week 36
timeFrame: Through study completion, an average of 36 weeks
Secondary outcomes:
measure: Absolute difference in average Urticaria Control Test (UCT) score at week 24
timeFrame: Through study completion, an average of 36 weeks
measure: Proportion of well-controlled patients (UCT score ≥ 12) at week 24 and 36
timeFrame: Through study completion, an average of 36 weeks
measure: Proportion of completely controlled patients (UCT score = 16) at week 24 and 36
timeFrame: Through study completion, an average of 36 weeks
measure: Difference in absolute UCT score measured as area under the curve (AUC)
timeFrame: Through study completion, an average of 36 weeks
measure: Absolute difference in average weekly urticaria activity score (UAS7) at week 24 and 36
timeFrame: Through study completion, an average of 36 weeks
measure: Proportion of well-controlled patients (UAS7 score < 7) at week 24 and 36
timeFrame: Through study completion, an average of 36 weeks
measure: Proportion of completely controlled patients (UAS7 score = 0) at week 24 and 36
timeFrame: Through study completion, an average of 36 weeks
measure: Differences in average Chronic Urticaria Quality of Life (CU-QoL) at week 24 and 36
timeFrame: Through study completion, an average of 36 weeks
measure: Differences in average dermatology life quality index (DLQI) at week 24 and 36
timeFrame: Through study completion, an average of 36 weeks
measure: Proportion of patients in the two treatment arms who experience flares
timeFrame: Through study completion, an average of 36 weeks
measure: Adverse event (AEs) and serious advese events (SAEs)
timeFrame: Through study completion, an average of 36 weeks
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Department of Dermatology, Bispebjerg Hospital
state: Copenhagen N
Study officials:
References: