[{"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:":40},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":4,"hasResults":10,"nctId":11,"briefTitle":12,"officialTitle":13,"acronym":14,"eligibilityCriteria":15,"healthyVolunteers":10,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":30,"startDateStruct":33,"completionDateStruct":35,"leadSponsor":37,"locationsCount":5},"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 Patients may therefore be withdrawn from the trial after enrolment, if they are found to have a positive BHRA test in the initial blood work.","ALL","18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":19,"type":20},40,"ESTIMATED","INTERVENTIONAL",[23],"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.",[26,27],"Chronic Spontaneous Urticaria","Chronic Urticaria, Idiopathic","RECRUITING","2025-09-16",{"date":31,"type":32},"2025-09-19","ACTUAL",{"date":34,"type":32},"2024-01-12",{"date":36,"type":20},"2025-12-31",{"name":38,"class":39},"Simon Francis Thomsen","OTHER",""]