[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100625669":3},{"organization":4,"armGroups":7,"interventions":18,"overallOfficials":10,"centralContacts":24,"locations":30,"responsibleParty":48,"collaborators":10,"id":50,"slug":51,"hasResults":52,"nctId":53,"briefTitle":54,"officialTitle":55,"acronym":56,"eligibilityCriteria":57,"healthyVolunteers":52,"sex":58,"minAge":59,"maxAge":10,"enrollmentInfo":60,"targetDuration":10,"studyType":63,"phases":10,"briefSummary":64,"conditions":65,"keywords":10,"overallStatus":33,"whyStopped":10,"lastUpdateSubmitDate":68,"lastUpdatePostDateStruct":69,"startDateStruct":72,"completionDateStruct":74,"leadSponsor":76,"locationsCount":77},{"fullName":5,"class":6},"Celltrion HealthCare France","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"CSU group",null,"Switch from omalizumab originator in patients with CSU",[13],"Drug: Omalizumab",{"label":15,"type":10,"description":16,"interventionNames":17},"Allergic asthma group","Switch from omalizumab originator in patients with allergic asthma",[13],[19],{"type":20,"name":21,"description":22,"armGroupLabels":23,"otherNames":10},"DRUG","Omalizumab","omalizumab biosimilar",[15,9],[25],{"name":26,"role":27,"phone":28,"phoneExt":10,"email":29},"Salim BENKHALIFA, MD","CONTACT","+33 1 71 25 27 00","rollyn-oma@sanoia.com",[31],{"facility":32,"status":33,"city":34,"state":10,"zip":10,"country":35,"countryCode":36,"cosmosGeoPoint":37,"geoPoint":42,"contacts":43},"CHU Montpellier","RECRUITING","Montpellier","France","FR",{"type":38,"coordinates":39},"Point",[40,41],3.87635,43.61093,{"lat":41,"lon":40},[44],{"name":45,"role":27,"phone":46,"phoneExt":10,"email":47},"Arnaud Bourdin, MD, PhD","+33 4 67 33 60 96","a-bourdin@chu-montpellier.fr",{"type":49,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR","100625669","rollyn-oma-an-observational-study-in-patients-treated-by-omlyclo-an-omalizumab-biosimilar-100625669",false,"NCT07425639","ROLL'YN-OMA: an Observational Study in Patients Treated by Omlyclo®, an Omalizumab Biosimilar","ROLL'YN-OMA : Etude Observationnelle de Cohorte Pour la Prise en Charge Des Patients Atteints de Pathologies Inflammatoires Chroniques traités Par Omlyclo®, un Omalizumab Biosimilaire","ROLL'YN-OMA","Inclusion Criteria:\n\n* Be an adult (aged 18 years or older at the time of inclusion) receiving specialist care and diagnosed with one of the following conditions: Severe asthma, Chronic Spontaneous Urticaria\n* Have been treated for at least 6 months prior to inclusion with the reference omalizumab for the relevant condition (Severe asthma or Chronic Spontaneous Urticaria).\n* Have been stable for at least 3 months according to the prescribing physician, with the disease controlled or in clinical remission based on the disease-specific activity score: Severe asthma: ≤ 1 course of oral corticosteroids per year related to disease worsening, without hospitalization, and ACQ \\\u003C 1.5 and FEV1 ≥ 80% of the patient's most recent values\u002F Chronic Spontaneous Urticaria : UCT ≥ 12\n* For whom the specialist physician has decided to switch to OMLYCLO® (biosimilar developed and marketed by Celltrion) on the day of patient inclusion (shared medical decision independent of the study).\n* Be able to start treatment within a maximum of 60 days following inclusion.\n* Have an email address.\n* Have a mobile phone number.\n* Be able to understand and complete questionnaires in French.\n* Not object to participating in the study.\n* Be affiliated with a French Social Security scheme or be a beneficiary of such a scheme\n\nExclusion Criteria:\n\n* Patients under guardianship or trusteeship, or otherwise deprived of liberty.\n* Pregnant women or women of childbearing potential with a desire to become pregnant during treatment with OMLYCLO®.\n* Patients who, at the time of inclusion, are participating in a clinical trial or another clinical study that prohibits simultaneous participation in other studies.\n* Contraindication to the study products.","ALL","18 Years",{"count":61,"type":62},225,"ESTIMATED","OBSERVATIONAL","ROLL'YN-OMA is a real-world study in patients receiving standard biologic therapies who have been in control and\u002For remission of their disease for at least 3 months and whose physician has independently decided, within the framework of a shared medical decision, to switch them to OMLYCLO®. The primary objective of this study is to evaluate the maintenance of this control and\u002For clinical remission 12 months after initiation of the biosimilar, and subsequently, patient satisfaction at 6 and 12 months.",[66,67],"Chronic Spontaneous Urticaria (CSU)","Allergic Asthma","2026-02-16",{"date":70,"type":71},"2026-02-23","ACTUAL",{"date":73,"type":71},"2025-10-02",{"date":75,"type":62},"2028-09",{"name":5,"class":6},1]