[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100587159":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":31,"centralContacts":38,"locations":49,"responsibleParty":69,"collaborators":72,"id":91,"slug":92,"hasResults":93,"nctId":94,"briefTitle":95,"officialTitle":96,"acronym":97,"eligibilityCriteria":98,"healthyVolunteers":93,"sex":99,"minAge":100,"maxAge":101,"enrollmentInfo":102,"targetDuration":26,"studyType":105,"phases":106,"briefSummary":109,"conditions":110,"keywords":112,"overallStatus":52,"whyStopped":26,"lastUpdateSubmitDate":117,"lastUpdatePostDateStruct":118,"startDateStruct":121,"completionDateStruct":123,"leadSponsor":125,"locationsCount":126},{"fullName":5,"class":6},"Second Xiangya Hospital of Central South University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Interleukin-2 treatment group","EXPERIMENTAL","The enrolled subjects will receive three cycles of interleukin-2 treatment in the first 12 weeks upon initiation of the intervention, while continuing with the same oral regimen of second-generation antihistamines as they have been receiving before initiation of the trial. In each cycle of interleukin-2 treatment, the enrolled subjects will receive an intramuscular injection of interleukin-2 at a dosage of 1 million international units, dissolved in 1.0 mL of sterile water for injection, once daily for 7 consecutive days. The three cycles of interleukin-2 treatment will be administered on Day 0\\~6, Day 28\\~34 and Day 56\\~62, respectively.",[13],"Drug: Human interleukin-2 (I) intramuscular injection",{"label":15,"type":16,"description":17,"interventionNames":18},"Placebo group","PLACEBO_COMPARATOR","The enrolled subjects will receive three cycles of placebo injections in the first 12 weeks upon initiation of the intervention, while continuing with the same oral regimen of second-generation antihistamines as they have been receiving before initiation of the trial. In each cycle of placebo injections, the enrolled subjects will receive an intramuscular injection of placebo at a same specification as in the IL-2 treatment group, dissolved in 1.0 mL of sterile water for injection, once daily for 7 consecutive days. The three cycles of placebo injections will be administered on Day 0\\~6, Day 28\\~34 and Day 56\\~62, respectively.",[19],"Drug: Placebo intramuscular injection",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","Placebo intramuscular injection","On the basis of background treatment, intramuscular injection of placebo was added.",[15],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"Human interleukin-2 (I) intramuscular injection","On the basis of background treatment, intramuscular injection of human interleukin-2 (I) will be added.",[9],[32,35],{"name":33,"affiliation":5,"role":34},"Hai Long, MD, PhD","PRINCIPAL_INVESTIGATOR",{"name":36,"affiliation":5,"role":37},"Qianjin Lu, MD, PhD","STUDY_DIRECTOR",[39,45],{"name":40,"role":41,"phone":42,"phoneExt":43,"email":44},"Hai Long, M.D. Ph.D.","CONTACT","86+18229743206","86+73185292097","Dr.hailong@csu.edu.cn",{"name":46,"role":41,"phone":47,"phoneExt":26,"email":48},"Guishao Tang, M.D.","86+15200900288","tang140503@163.com",[50],{"facility":51,"status":52,"city":53,"state":54,"zip":55,"country":56,"countryCode":57,"cosmosGeoPoint":58,"geoPoint":63,"contacts":64},"the Second Xiangya Hospital of Central South University","RECRUITING","Changsha","Hunan","410000","China","CN",{"type":59,"coordinates":60},"Point",[61,62],112.97087,28.19874,{"lat":62,"lon":61},[65],{"name":66,"role":41,"phone":67,"phoneExt":26,"email":68},"Prof. Zhuo Li, M.D.","86+85292097","xy2gcphyb@163.com",{"type":34,"investigatorFullName":70,"investigatorTitle":71,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"Hai Long","M.D., Ph.D. & Vice President, The Second Xiangya Hospital of Central South University",[73,75,77,79,81,83,85,87,89],{"name":74,"class":6},"Xiangya Hospital of Central South University",{"name":76,"class":6},"Third Affiliated Hospital, Sun Yat-Sen University",{"name":78,"class":6},"Tongji Hospital",{"name":80,"class":6},"West China Hospital",{"name":82,"class":6},"First Affiliated Hospital of Guangxi Medical University",{"name":84,"class":6},"Fujian Medical University Union Hospital",{"name":86,"class":6},"Second Affiliated Hospital of Guangzhou Medical University",{"name":88,"class":6},"The First People's Hospital of Changde City",{"name":90,"class":6},"The Third People's Hospital of Hangzhou","100587159","phase-2-interleukin-2-for-refractory-chronic-spontaneous-urticaria-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":103,"type":104},124,"ESTIMATED","INTERVENTIONAL",[107,108],"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.",[111],"Chronic Spontaneous Uriticaria",[113,114,115,116],"Interleukin-2","Chronic spontaneous uriticaria","urticaria control test","poor response to second-generation antihistamines","2025-04-06",{"date":119,"type":120},"2025-04-11","ACTUAL",{"date":122,"type":120},"2025-03-19",{"date":124,"type":104},"2026-05-31",{"name":5,"class":6},1]