[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100509707":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":31,"centralContacts":32,"locations":42,"responsibleParty":61,"collaborators":65,"id":68,"slug":69,"hasResults":70,"nctId":71,"briefTitle":72,"officialTitle":73,"acronym":74,"eligibilityCriteria":75,"healthyVolunteers":70,"sex":76,"minAge":77,"maxAge":31,"enrollmentInfo":78,"targetDuration":31,"studyType":81,"phases":82,"briefSummary":84,"conditions":85,"keywords":31,"overallStatus":45,"whyStopped":31,"lastUpdateSubmitDate":88,"lastUpdatePostDateStruct":89,"startDateStruct":92,"completionDateStruct":94,"leadSponsor":96,"locationsCount":97},{"fullName":5,"class":6},"Bispebjerg Hospital","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"omalizumab 300 mg every six weeks","ACTIVE_COMPARATOR","20 subjects are randomized to receive omalizumab 300 mg every six weeks from week 12 to week 36.",[13],"Drug: omalizumab 300 mg every six weeks",{"label":15,"type":10,"description":16,"interventionNames":17},"omalizumab 300 mg every four weeks","20 subjects are randomized to receive omalizumab 300 mg every four weeks from week 12 to week 36.",[18],"Drug: omalizumab 300 mg every four weeks",[20,26],{"type":21,"name":15,"description":22,"armGroupLabels":23,"otherNames":24},"DRUG","Continue standard treatment with omalizumab 300 mg every four weeks from week 12 to week 36.\n\nBoth arms are treated with omalizumab 300 mg from week 0 to week 12.",[15],[25],"Standard treatment",{"type":21,"name":9,"description":27,"armGroupLabels":28,"otherNames":29},"Treatment in an extended interval of omalizumab 300 mg every six weeks from week 12 to week 36.\n\nBoth arms are treated with omalizumab 300 mg from week 0 to week 12.",[9],[30],"Extended treatment",null,[33,38],{"name":34,"role":35,"phone":36,"phoneExt":31,"email":37},"Simon F Thomsen, MD, DMSc","CONTACT","+4526139838","simon.francis.thomsen.02@regionh.dk",{"name":39,"role":35,"phone":40,"phoneExt":31,"email":41},"Ditte G Zhang, MD","+4520994864","DZHA0006@regionh.dk",[43],{"facility":44,"status":45,"city":46,"state":47,"zip":48,"country":49,"countryCode":50,"cosmosGeoPoint":51,"geoPoint":56,"contacts":57},"Department of Dermatology, Bispebjerg Hospital","RECRUITING","Copenhagen","Copenhagen N","2100","Denmark","DK",{"type":52,"coordinates":53},"Point",[54,55],12.56553,55.67594,{"lat":55,"lon":54},[58,60],{"name":59,"role":35,"phone":36,"phoneExt":31,"email":37},"Simon F Thomsen, DMSc",{"name":39,"role":35,"phone":40,"phoneExt":31,"email":41},{"type":62,"investigatorFullName":63,"investigatorTitle":64,"investigatorAffiliation":5,"oldNameTitle":31,"oldOrganization":31},"SPONSOR_INVESTIGATOR","Simon Francis Thomsen","DM, PhD, DMSc",[66],{"name":67,"class":6},"Aarhus University Hospital","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":79,"type":80},40,"ESTIMATED","INTERVENTIONAL",[83],"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.",[86,87],"Chronic Spontaneous Urticaria","Chronic Urticaria, Idiopathic","2025-09-16",{"date":90,"type":91},"2025-09-19","ACTUAL",{"date":93,"type":91},"2024-01-12",{"date":95,"type":80},"2025-12-31",{"name":63,"class":6},1]