[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"chronic-spontaneous-uriticaria\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:chronic-spontaneous-uriticaria":46},{"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":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":26,"conditions":27,"keywords":29,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":36,"startDateStruct":39,"completionDateStruct":41,"leadSponsor":43,"locationsCount":5},"100587159",false,"NCT06924762","Interleukin-2 for Refractory Chronic Spontaneous Urticaria","Efficacy and Safety of Interleukin-2 Treatment in Moderate to Severe Chronic Spontaneous Urticaria With Poor Control by Antihistamines: a Multicenter, Randomized, Double-blind, Placebo-controlled Clinical Trial","ESIT-CSU","Inclusion Criteria:\n\n1. Gender: Not limited; Age: at least 18 years old and less than 75 years old;\n2. Diagnosed with chronic spontaneous urticaria (CSU) (including patients overlapped with chronic inducible urticaria) according to the 2021 EAACI\u002FGA²LEN\u002FEDF\u002FAAAAI guidelines;\n3. Disease course of CSU for at least 12 weeks;\n4. The patient has been treated with second-generation antihistamines (one or more types, up to 4 tablets per day) every day for 2 weeks or more but still experiences significant symptoms of wheals and\u002For itching, with a UAS7 score ≥16 or a UCT score \\\u003C12;\n5. UAS7 ≥16 on the date prior to randomization (according to complete daily symptom log data recorded in the past 7 days before randomization);\n6. Willing and able to complete daily symptom logs throughout the entire study period;\n7. The patient voluntarily consents to participate in this research project and has signed the informed consent.\n\nExclusion Criteria:\n\n* Pregnant or breastfeeding women, or women planning to conceive within 6 months;\n* Has used corticosteroids, immunosuppressants, leukotriene receptor antagonists, H2 receptor antagonists, intravenous immunoglobulin (IVIG) therapy, and\u002For undergone plasma exchange in the past 4 weeks;\n* Has received omalizumab or other biologic treatments in the past 12 weeks;\n* Has previously undergone interleukin-2 treatment;\n* Has a history of anaphylactic shock;\n* Plans or anticipates the use of any prohibited drugs or treatments during the screening and\u002For treatment periods;\n* Currently has active or recurrent severe infections, such as active tuberculosis;\n* Has a congenital or acquired immunodeficiency disorder;\n* Has a history of drug or alcohol abuse, mental disorders, or poor compliance, making them unable to adhere to treatment;\n* Currently enrolled in another clinical trial;\n* Is an employee of the clinical research facility or directly involved in the study, or is an immediate family member of such an individual;\n* Any other reason that makes participation in this trial inappropriate.","ALL","18 Years","74 Years",{"count":20,"type":21},124,"ESTIMATED","INTERVENTIONAL",[24,25],"PHASE2","PHASE3","The goal of this clinical trial is to learn if human interleukin-2 (IL-2) works to treat moderate to severe chronic spontaneous urticaria in adults who remain symptomatic despite oral antihistamine treatment (refractory CSU). It will also learn about the safety of IL-2. The main questions it aims to answer are:\n\nDoes IL-2 alleviate the symptoms of urticaria in patients? What medical problems do participants have when given IL-2? Researchers will compare IL-2 to a placebo (a look-alike and smell-like substance that contains no IL-2) to see if IL-2 works to treat refractory, moderate to severe CSU.\n\nParticipants will:\n\nReceive IL-2 or a placebo intramuscular injections for 3 rounds at Week 0, 4 and 8, in which each round includes one injection daily for seven consecutive days.\n\nVisit the clinic for checkups and tests at Week 2, 4, 8, 12 and 24. Keep a diary of their symptoms and the number of tablets of oral antihistamines.",[28],"Chronic Spontaneous Uriticaria",[30,31,32,33],"Interleukin-2","Chronic spontaneous uriticaria","urticaria control test","poor response to second-generation antihistamines","RECRUITING","2025-04-06",{"date":37,"type":38},"2025-04-11","ACTUAL",{"date":40,"type":38},"2025-03-19",{"date":42,"type":21},"2026-05-31",{"name":44,"class":45},"Second Xiangya Hospital of Central South University","OTHER",""]