[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Simon Francis Thomsen\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":41},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":31,"startDateStruct":34,"completionDateStruct":36,"leadSponsor":38,"locationsCount":5},"100509707","phase-4-extending-omalizumab-treatment-intervals-in-patients-with-chronic-spontaneous-urticaria-100509707",false,"NCT05916937","Extending Omalizumab Treatment Intervals in Patients With Chronic Spontaneous Urticaria","Extending Omalizumab Treatment Intervals in Patients With Chronic Spontaneous Urticaria (EXOTIC Trial): a Multicentre, Randomized, Open-label, Non-inferiority Trial","EXOTIC","Inclusion Criteria:\n\n* A diagnosis of CSU according to the EAACI\u002FGA2LEN\u002FEDF\u002FWAO guidelines.\n* Age ≥ 18 years.\n* Omalizumab-naïve prior to initiating treatment with omalizumab.\n* Background treatment with four antihistamines daily.\n* Candidate for omalizumab treatment according to Danish guidelines.\n\nExclusion Criteria:\n\n* Pregnant or breastfeeding women.\n* Planned pregnancy within the next 6 months.\n* Weight ≥ 100 kilograms.\n* 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.\n* Use of immunosuppressive drugs, such as prednisolone, azathioprine, methotrexate, or cyclosporine.\n* Predominantly experience symptoms from chronic inducible urticaria (CIndU).\n* Inability to complete study or comply with study procedures.\n\nPatients 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 Patients may therefore be withdrawn from the trial after enrolment, if they are found to have a positive BHRA test in the initial blood work.","ALL","18 Years",{"count":20,"type":21},40,"ESTIMATED","INTERVENTIONAL",[24],"PHASE4","This study is a multicentre, randomized, open-label, non-inferiority clinical trial.\n\nThe 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.",[27,28],"Chronic Spontaneous Urticaria","Chronic Urticaria, Idiopathic","RECRUITING","2025-09-16",{"date":32,"type":33},"2025-09-19","ACTUAL",{"date":35,"type":33},"2024-01-12",{"date":37,"type":21},"2025-12-31",{"name":39,"class":40},"Simon Francis Thomsen","OTHER",""]