[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100634961":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":26,"centralContacts":31,"locations":26,"responsibleParty":37,"collaborators":26,"id":39,"slug":40,"hasResults":41,"nctId":42,"briefTitle":43,"officialTitle":44,"acronym":26,"eligibilityCriteria":45,"healthyVolunteers":41,"sex":46,"minAge":47,"maxAge":48,"enrollmentInfo":49,"targetDuration":26,"studyType":52,"phases":53,"briefSummary":55,"conditions":56,"keywords":58,"overallStatus":60,"whyStopped":26,"lastUpdateSubmitDate":61,"lastUpdatePostDateStruct":62,"startDateStruct":65,"completionDateStruct":67,"leadSponsor":69,"locationsCount":26},{"fullName":5,"class":6},"Shanghai Mabgeek Biotech.Co.Ltd","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"MG-K10 humanized monoclonal antibody injection","EXPERIMENTAL","Usage and dosage: Administer once every 4 weeks, with an initial dose of 600mg (4.0 ml) and subsequent doses of 300mg (2.0 ml)",[13],"Biological: MG-K10 Humanized Monoclonal Antibody Injection",{"label":15,"type":16,"description":17,"interventionNames":18},"placebo","PLACEBO_COMPARATOR","Medication schedule: placebo received on Day 1 (D1) and Week 24 (W24), MG-K10 300mg Q4W received from Week 24 (W24) to Week 48 (W48)",[19],"Biological: Placebo",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"BIOLOGICAL","MG-K10 Humanized Monoclonal Antibody Injection","Administer once every 4 weeks, with an initial dose of 600mg (4.0 ml) and subsequent doses of 300mg (2.0 ml).",[9],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"Placebo","Received placebo on Day 1 (D1) and Week 24 (W24), started receiving MG-K10 300mg Q4W from Week 24 (W24) to Week 48 (W48)",[15],[32],{"name":33,"role":34,"phone":35,"phoneExt":26,"email":36},"Clinical Project Manager","CONTACT","+86-021-51371305","xiaofeng.cai@mabgeek.com",{"type":38,"investigatorFullName":26,"investigatorTitle":26,"investigatorAffiliation":26,"oldNameTitle":26,"oldOrganization":26},"SPONSOR","100634961","phase-3-a-study-of-mg-k10-in-chronic-spontaneous-urticaria-100634961",false,"NCT07546487","A Study of MG-K10 in Chronic Spontaneous Urticaria","A Randomized, Double-Blind, Placebo-Controlled Phase III Clinical Study Evaluating the Efficacy and Safety of MG-K10 Humanized Monoclonal Antibody Injection in Patients With Chronic Spontaneous Urticaria","Inclusion Criteria:\n\n1. Aged ≥12 and ≤75 years, body weight ≥30 kg, voluntarily sign ICF.\n2. Diagnosed with CSU for ≥6 months, with pruritus and wheals for \\>6 weeks despite using second-generation H1 antihistamines.\n3. Within 7 days prior to randomization: UAS7 score ≥16, ISS7 score ≥8, and at least one UAS ≥4.\n\n3.Willing to maintain stable background antihistamine dose during the study (up to 4 times standard dose allowed).\n\n4.Agree to use effective contraception during the study and for 6 months after last dose.\n\nExclusion Criteria:\n\n1. Inducible urticaria (e.g., dermographism, cold, heat, cholinergic) or other chronic pruritic skin diseases (e.g., atopic dermatitis) affecting study assessment.\n2. Active tuberculosis, or untreated latent TB; serious active infections.\n3. Known or suspected immunodeficiency, or history of invasive opportunistic infections.\n4. Known allergy to study drug or excipients.\n5. Prior use of MG-K10 or other biologics (anti-IL-4Rα, anti-IgE, etc.) within 16 weeks or 5 half-lives.\n6. Use of immunosuppressants, systemic corticosteroids, phototherapy, or Chinese herbal medicine within 4 weeks prior to first UAS assessment.\n7. Clinically significant laboratory abnormalities at screening: ANC \\\u003C1.2×10⁹\u002FL, platelets \\\u003C90×10⁹\u002FL, ALT\u002FAST\u002Ftotal bilirubin \\>2×ULN, creatinine \\>1.5×ULN.\n8. Positive for HBsAg, or HBcAb positive with HBV-DNA ≥1×10³ copies\u002Fml; HCV-Ab positive with HCV-RNA positive; HIV antibody positive.\n9. QTcF \\>500 msec or other clinically significant ECG abnormalities.\n10. Pregnant, breastfeeding, or planning pregnancy during the study.\n11. History of malignant tumors within 5 years (except adequately treated non-melanoma skin cancer or cervical carcinoma in situ).\n12. Participated in another clinical study and used investigational drug within 12 weeks or 5 half-lives prior to first UAS assessment.","ALL","12 Years","75 Years",{"count":50,"type":51},226,"ESTIMATED","INTERVENTIONAL",[54],"PHASE3","This study is a multicenter, randomized, double-blind, placebo-controlled phase III clinical trial aimed at evaluating the efficacy and safety of MG-K10 humanized monoclonal antibody injection in CSU trial participants with poor control of second-generation H1 antihistamines.",[57],"Chronic Spontaneous Urticaria (CSU)",[59],"MG-K10","NOT_YET_RECRUITING","2026-04-16",{"date":63,"type":64},"2026-04-22","ACTUAL",{"date":66,"type":51},"2026-04-14",{"date":68,"type":51},"2028-03-31",{"name":5,"class":6}]