[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Shanghai Mabgeek Biotech.Co.Ltd\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":201},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,8,0,[8,42,65,88,112,136,157,179],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":28,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":32,"startDateStruct":35,"completionDateStruct":37,"leadSponsor":39,"locationsCount":4},"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":20,"type":21},226,"ESTIMATED","INTERVENTIONAL",[24],"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.",[27],"Chronic Spontaneous Urticaria (CSU)",[29],"MG-K10","NOT_YET_RECRUITING","2026-04-16",{"date":33,"type":34},"2026-04-22","ACTUAL",{"date":36,"type":21},"2026-04-14",{"date":38,"type":21},"2028-03-31",{"name":40,"class":41},"Shanghai Mabgeek Biotech.Co.Ltd","INDUSTRY",{"id":43,"slug":44,"hasResults":11,"nctId":45,"briefTitle":46,"officialTitle":47,"acronym":4,"eligibilityCriteria":48,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":49,"enrollmentInfo":50,"targetDuration":4,"studyType":22,"phases":52,"briefSummary":53,"conditions":54,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":56,"lastUpdatePostDateStruct":57,"startDateStruct":59,"completionDateStruct":61,"leadSponsor":63,"locationsCount":64},"100634496","phase-3-a-phase-iii-study-of-mg-k10-in-adolescents-with-moderate-to-severe-atopic-dermatitis-100634496","NCT07540442","A Phase III Study of MG-K10 in Adolescents With Moderate-to-Severe Atopic Dermatitis","Phase III, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of MG-K10 (a Humanized Monoclonal Antibody Injection) in Adolescents With Moderate-to-Severe Atopic Dermatitis","Inclusion Criteria:\n\n1. Diagnosis of Atopic Dermatitis (AD) per American Academy of Dermatology (2014) criteria for ≥6 months;\n2. Eczema Area and Severity Index (EASI) ≥16;\n3. Investigator's Global Assessment (IGA) ≥3;\n4. Body Surface Area (BSA) involvement ≥10%;\n5. Peak Pruritus Numerical Rating Scale (NRS) weekly average ≥4;\n6. Inadequate response to topical treatments within 6 months or medically inadvisable to use topical treatments.\n\nExclusion Criteria:\n\n1. Inability to tolerate venipuncture, or a history of needle phobia or hematophobia;\n2. Inability to receive subcutaneous injections, such as patients currently receiving anticoagulant therapy, or those with known bleeding disorders or idiopathic thrombocytopenic purpura;\n3. Presence of ophthalmic diseases judged by the investigator to be unsuitable for inclusion;\n4. Concurrent serious diseases including, but not limited to, cardiovascular, metabolic, or neurological diseases, which, in the opinion of the investigator, render the subject unsuitable for immunosuppressive therapy;\n5. History of parasitic infection within 6 months prior to screening;\n6. Planned major surgery during the study period;\n7. Prior or concomitant treatments meeting any of the following:\n\n   * Use of biologics within 10 weeks prior to randomization or within 5 half-lives (whichever is longer)\n   * Use of targeted inhibitors (e.g., JAK inhibitors), systemic glucocorticoids, cyclosporine, or other immunosuppressants (e.g., methotrexate, MMF, azathioprine), phosphodiesterase-4 (PDE4) inhibitors, phototherapy (UV), or systemic Chinese herbal medicine for AD within 4 weeks prior to randomization\n   * Use of topical treatments for AD (e.g., topical glucocorticoids, topical calcineurin inhibitors, antibiotic combination creams, or topical Chinese herbal medicine) within 2 weeks prior to randomization\n   * Receipt of live or attenuated vaccines within 3 months prior to randomization or plans to receive such vaccines during the study\n   * Participation in other clinical trials within 3 months or 5 half-lives (whichever is longer) prior to randomization, or plans to participate in other clinical trials during the study period\n   * Systemic anti-infective therapy (oral or intravenous antibacterial, antiviral, or antifungal) within 4 weeks prior to randomization, or current acute or subacute infection indicated by symptoms, signs, or laboratory abnormalities\n8. History of alcohol or drug abuse within 6 months prior to screening; Known allergy or intolerance to any component of the investigational product.\n9. Other conditions that, in the opinion of the investigator, make the subject unsuitable for participation in the study.","17 Years",{"count":51,"type":21},180,[24],"This is a randomized, double-blind, placebo-controlled, parallel group study to confirm the efficacy and safety of MG-K10 monotherapy in adolescents with moderate-to-severe atopic dermatitis (AD)",[55],"Dermatitis, Atopic","2026-04-13",{"date":58,"type":34},"2026-04-20",{"date":60,"type":21},"2026-04-17",{"date":62,"type":21},"2027-11-09",{"name":40,"class":41},1,{"id":66,"slug":67,"hasResults":11,"nctId":68,"briefTitle":69,"officialTitle":70,"acronym":71,"eligibilityCriteria":72,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":73,"targetDuration":4,"studyType":22,"phases":75,"briefSummary":76,"conditions":77,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":80,"lastUpdatePostDateStruct":81,"startDateStruct":83,"completionDateStruct":85,"leadSponsor":87,"locationsCount":4},"100629818","phase-3-a-study-to-evaluate-the-efficacy-and-safety-of-mg-k10-in-participants-who-have-atopic-dermatitis-100629818","NCT07479615","A Study to Evaluate the Efficacy and Safety of MG-K10 in Participants Who Have Atopic Dermatitis","A Randomized, Double-Blind, Placebo-Controlled Phase III Clinical Study of MG-K10 Humanized Monoclonal Antibody Injection in Adult and Adolescent Patients With Moderate To-Severe Atopic Dermatitis","ADaggio","Inclusion Criteria:\n\n1. Age: ≥12 years, both males and females.\n2. Diagnosed with AD (according to the 2014 American Academy of Dermatology Consensus Criteria) that has been present for ≥1 year before the screening visit, and meeting the following conditions:\n3. Within 6 months prior to the screening visit, the patient has shown an insufficient response to topical medication or is medically unsuitable for topical treatment (e.g., significant side effects or safety risks).\n4. Participants should start a stable dose of moisturizer from the signing of ICF, apply a moisturizer twice daily for at least 7 consecutive days prior to randomization and continue using it throughout the study period.\n5. Women of childbearing age have a negative blood pregnancy test result during the screening period.\n6. Participants and their partners agree to use effective contraception from the time of signing the Informed Consent Form (ICF) until 6 months after the end of treatment ; no donation or freezing of germ cells is allowed from the time of signing the ICF until 6 months after the end of treatment.\n7. The participant voluntarily signs the ICF and can comply with all required visits and study-related procedures outlined in the protocol.\n8. For participants ≥ 12 and \\\u003C 18 years of age at Screening Visit: Parent or legal guardian, as required, has voluntarily signed and dated an informed consent form, approved by an IEC, after the nature of the stud has been explained and the participant's parent or legal guardian has had the opportunity to ask questions.\n\nExclusion Criteria:\n\n1. Body weight \\\u003C 30 kilograms (kg).\n2. The participant currently has a diagnosis of another active skin disease that may affect AD evaluation (e.g., psoriasis or lupus erythematosus).\n3. Known allergies to any component of the investigational drug.\n4. The participant cannot tolerate venipuncture or have a history of needle or blood phobia.\n5. The participant has comorbidities that may require systemic steroid therapy, other intervention measures, or require active and frequent monitoring.\n6. Those with significant cardiac, pulmonary, gastrointestinal, hepatic, renal, hematologic, neurologic, and psychiatric disorders that are unstable or not well controlled and are considered clinically significant by the investigator.\n7. Participants with ocular diseases deemed unsuitable for study entry by the investigator, such as a history of atopic keratoconjunctivitis involving the cornea.\n8. Participants are planning to undergo major surgery during the study period, including inpatient and outpatient surgeries.\n9. Patients with malignant tumors within 5 years\n10. Participants with any of the following conditions within the related timeline:\n\n    * Use of biologics\n    * Use of targeted inhibitors (e.g., JAK inhibitors), systemic corticosteroids, cyclosporine, or other immunosuppressants\n    * Use of topical treatments for AD\n    * Receipt of allergen-specific immunotherapy\n    * Vaccination with live or attenuated live vaccines\n    * Participation in another clinical drug study\n    * Previous use of interleukin-4 receptor alpha (IL-4Rα) or interleukin-13 (IL-13) monoclonal antibody drugs\n11. Received systemic (oral or intravenous) antibacterial, antiviral, or antifungal treatment within 4 weeks prior to randomization.\n12. Evidence of active tuberculosis, or previous evidence of active tuberculosis without documented adequate treatment\n13. Diagnosis of active parasitic infection; suspected parasitic infection or high risk of infection unless clinical and (if necessary) laboratory evaluations have ruled out active infection prior to randomization.\n14. Laboratory results at screening showing any of the abnormalities\n15. Abnormal 12-lead electrocardiogram (ECG) at screening\n16. Active hepatitis at screening, or positive for hepatitis B surface antigen (HBsAg), or positive for hepatitis B core antibody (HBcAb) with hepatitis B virus DNA (HBV-DNA) positive, or positive for hepatitis C virus (HCV) antibodies with HCV RNA positive.\n17. History of human immunodeficiency virus (HIV) infection, or positive for HIV antibodies at screening\n18. Positive for Treponema pallidum antibodies (TP-Ab) at screening, except if rapid plasma reagin (RPR) or Toluidine Red Unheated Serum Test (TRUST) results are negative\n19. History of illicit drug use, drug abuse, or excessive alcohol consumption\n20. Women who are breastfeeding, pregnant, or planning to become pregnant or breastfeed during the study period.\n21. Any other conditions that the investigator considers inappropriate for study participation.\n\n    \\-",{"count":74,"type":21},498,[24],"Rationale (What is the reason for this study?) Atopic dermatitis (AD) is a condition that makes the skin dry and itchy and is the most common skin condition that causes redness and irritation.\n\nThe exact cause of AD is unclear but genetic and environmental factors are believed to play a role. Common treatment options for participants with AD include basic skin care, medicine that is applied to the skin, and medicine that works in more than one part of the body. Typically, these treatment options work for participants with AD but some have skin lesions (skin sores or damaged skin) over large areas of the body and do not see an improvement in their AD symptoms. MG-K10 has been shown to be effective in treating participants with moderate-to-severeatopic dermatitis in Phase 2 studies (Chaoying Gu et al.2025) and has already completed a Phase 3 clinical study for adults in China. This study aims to evaluate the efficacy and safety of MG-K10 in the adolenscents and adults with moderate-to-severeatopic dermatitis in global population.\n\nObjectives (goals of the study) and Endpoints (how goals are measured) Check how MG-K10 treatment affects atopic dermatitis Study doctors will look at the safety of MG-K10 and if any side effects are reported by participants when they take it.\n\nCheck how the body processes MG-K10 Check how MG-K10 affects the biomarkers of effect Check how the body's immune system (the body's defense system) reacts to MG-K10",[78,79],"Atopic Dermatitis","Atopic Eczema","2026-03-15",{"date":82,"type":34},"2026-03-18",{"date":84,"type":21},"2026-05-01",{"date":86,"type":21},"2029-01",{"name":40,"class":41},{"id":89,"slug":90,"hasResults":11,"nctId":91,"briefTitle":92,"officialTitle":93,"acronym":29,"eligibilityCriteria":94,"healthyVolunteers":11,"sex":16,"minAge":95,"maxAge":18,"enrollmentInfo":96,"targetDuration":4,"studyType":22,"phases":98,"briefSummary":100,"conditions":101,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":103,"lastUpdatePostDateStruct":104,"startDateStruct":106,"completionDateStruct":108,"leadSponsor":110,"locationsCount":111},"100600875","phase-2-a-study-of-mg-k10-humanized-monoclonal-antibody-injection-in-subjects-with-atopic-dermatitis-100600875","NCT07103174","A Study of MG-K10 Humanized Monoclonal Antibody Injection in Subjects With Atopic Dermatitis","A Phase II Clinical Study on the Efficacy and Safety of MG-K10 Humanized Monoclonal Antibody Injection in Patients With Moderate to Severe Atopic Dermatitis","Inclusion Criteria:\n\n1. AD patients diagnosed in accordance with the consensus criteria of the American Academy of Dermatology (2014) had a history of AD or eczema diagnosis of ≥1 year\n2. The patient's response to topical medication treatment is insufficient, or it is medically inappropriate to use topical medication for treatment\n3. The subjects and their partners agreed to take effective contraceptive measures from signing the Informed Consent Form (ICF) until 6 months after the end of treatment, and had no plans for childbirth, sperm donation or egg donation\n\nExclusion Criteria:\n\n1. The subject currently has a diagnosis of other active skin diseases (such as psoriasis or lupus erythematosus) that may affect the evaluation of AD\n2. Patients with eye diseases that the researchers judged as unsuitable for inclusion\n3. Patients with malignant tumors within 5 years\n4. There is evidence of active tuberculosis, or there has been evidence of active tuberculosis before and no appropriate documented treatment has been received\n5. Confirm active parasitic infection\n6. Those with active hepatitis, or positive for hepatitis B surface antigen (HBsAg), or positive for hepatitis B core antibody (HBcAb), or positive for hepatitis C virus (HCV) antibody, or positive for HIV antibody, or positive for (TP-Ab)\n7. Women who are breastfeeding or pregnant, or women planning to become pregnant or breastfeed during the study period\n8. Those who the researchers consider to have other circumstances that make them unsuitable to participate in the study","18 Years",{"count":97,"type":21},60,[99],"PHASE2","This study is a multicenter, randomized, double-blind, parallel controlled phase II study. It is planned to include approximately 60 subjects with moderate to severe atopic dermatitis(AD) to evaluate the efficacy and safety of MG-K10 monotherapy in adult patients with moderate to severe AD, and to observe PK characteristics, PD effects and immunogenicity.",[102],"Atopic Dermatitis (AD)","2025-08-01",{"date":105,"type":34},"2025-08-05",{"date":107,"type":21},"2025-08-16",{"date":109,"type":21},"2027-12-16",{"name":40,"class":41},2,{"id":113,"slug":114,"hasResults":11,"nctId":115,"briefTitle":116,"officialTitle":117,"acronym":4,"eligibilityCriteria":118,"healthyVolunteers":11,"sex":16,"minAge":95,"maxAge":18,"enrollmentInfo":119,"targetDuration":4,"studyType":22,"phases":121,"briefSummary":122,"conditions":123,"keywords":125,"overallStatus":127,"whyStopped":4,"lastUpdateSubmitDate":128,"lastUpdatePostDateStruct":129,"startDateStruct":131,"completionDateStruct":133,"leadSponsor":135,"locationsCount":64},"100581136","phase-2-phase-iiiii-seamless-clinical-study-of-mg-k10-humanized-monoclonal-antibody-injection-in-treatment-of-seasonal-allergic-rhinitis-100581136","NCT06846385","Phase II\u002FIII Seamless Clinical Study of MG-K10 Humanized Monoclonal Antibody Injection in Treatment of Seasonal Allergic Rhinitis","A Multicenter, Randomized, Double-blind, Placebo-controlled Phase II\u002FIII Seamless Clinical Study Evaluating the Efficacy, Safety, PK, PD, and ADA of MG-K10 Humanized Monoclonal Antibody Injection in the Treatment of Seasonal Allergic Rhinitis","Inclusion Criteria:\n\n* Age of 18-75 years old (including the cutoff value), male or female;\n* With reference to the diagnosis and treatment of allergic rhinitis China guide (2022 revision) \"subjects conforms to the diagnosis of seasonal allergic rhinitis, history 2 years or more clear, at the same time, at least one over the same period of the current season or allergic rhinitis disease related Skin prick test (Skin Prick Test, SPT) or serum Specific IgE (sIgE) (acceptable within less than 1 year before randomization), and the results met the diagnostic criteria for SAR\n* During the previous pollen season, the subjects used nasal corticosteroids or other SAR drugs (antihistamines, leukotriene receptor antagonists, etc.), and their SAR symptoms were poorly controlled.\n* The following criteria were met at screening and baseline:\n\n  1. iTNSS score at screening ≥6, nasal congestion ≥2, runny nose, nasal itching, and sneezing 3. One of the symptoms ≥2 points;\n  2. iTNSS score ≥6 at baseline; rTNSS≥6 points, nasal congestion ≥2 points, runny nose, nose,one of the three symptoms of itching and sneezing ≥2 points\n* Throughout the study period (from signing the ICF to 6 months after the study drug administration), fertile female subjects and their partners agreed to use highly effective birth control, and male subjects and their partners agreed to use effective birth control and had no plans to donate sperm (men) or eggs (women)\n* Be able to understand and comply with clinical protocol requirements, voluntarily participate in clinical trials, and subjects voluntarily sign written informed consent.\n\nExclusion Criteria:\n\n* Allergy to the study drug or its excipients;\n* Travel plans for 48 hours or more from known pollen areas during the screening\u002Finduction and treatment periods (visit 5);\n* The subject's exposure to allergens in his or her home or work environment may have changed significantly during the trial, which the investigator determines may affect the efficacy evaluator;\n* Subjects with limited outdoor activities during the day were defined as those who did not have any outdoor activities during the day for 1 or 4 days per week.\n\n  ·Patients who have previously received anti-interleukin-4 receptor alpha (IL-4Rα) monoclonal antibody drugs (such as dupriuzumab) for Allergic Rhinitis (AR) have poor response (such as treatment failure or treatment intolerance);\n* Use of antihistamines within 4 days prior to randomization;\n* Leukotriene receptor antagonists and hypertrophic cell membrane stabilizers were used within 1 week before randomization;\n* Received medium - and short-acting Systemic Crticosteroids (SCS, including oral, intravenous and intramuscular glucocorticoids) and Chinese medicine for AR treatment (systemic Chinese medicine preparation) within 4 weeks before randomization. Had received long-acting SCS (such as triamcinolone olone injection) within 6 weeks prior to randomization, or planned to receive these medications during the study period;\n* Participants with asthma who began inhaled glucocorticoid therapy within the first 4 weeks of randomization.\n* Stable dose inhaled glucocorticoids were used for at least 4 weeks and evaluated before randomization\n* The dose of inhaled glucocorticoids was maintained during the study period, while the dosage of inhaled glucocorticoids was ≤1000 μg\u002F day of fluticasone propionate or equivalent doses of other inhaled glucocorticoids\n* Randomized 8 weeks or 5 Systemic immunosuppressants (including but not limited to methotrexate, cyclosporine, mycophenolate, tacrolimus, penicillamine, sulfasulazopyridine, hydroxychloroquine, azathioprine, cyclophosphamide) have been used within a half-life (whichever is longer) to treat inflammatory or autoimmune diseases (e.g., rheumatoid arthritis, inflammatory bowel disease, primary biliary cirrhosis, systemic disease) Lupus erythematosus, multiple sclerosis, etc);\n* random or 10 weeks before 5 within the half-life of longer (in time) received anti IL - 4 r alpha monoclonal antibody, Thymic Stromal lymphocytes (Thymic Stromal Lymphopoietin, TSLP) monoclonal antibody, anti-IGE monoclonal antibody, other monoclonal antibody or other biologic agent therapy;\n* Participated in MG-K10 clinical trials;\n* Live\u002Fattenuated vaccine received within 3 months prior to randomization or during the planned study period; Subjects who started Immunotherapy \\[including Intravenous Immunoglobin (IVIG) therapy or Specific Immunotherapy (SIT) therapy\\] within 6 months before randomization, Participants who plan to begin immunotherapy during the study;\n* Had received any nasal or sinus surgery within 1 year prior to randomization;\n* History of vital organ transplantation (e.g., heart, lung, kidney, liver) or hematopoietic stem cell\u002Fbone marrow transplantation\n* Other nasal comorbiditis or co-occurring diseases\u002Fconditions (such as acute\u002Fchronic sinusitis, nasal polyps, deviation of nasal septum, drug-induced rhinitis, cerebrospinal fluid rhinorrhea, nasal postoperative status within 1 year, etc.) were present at the time of screening and could affect the efficacy evaluation as assessed by the investigators;\n* Acute sinusitis, nasal infection, or upper respiratory tract infection during the screening\u002Finduction period or within 2 weeks prior to screening;\n* Have malignant or benign tumors in the nasal cavity;\n* Screening for infections requiring treatment with systemic antimicrobials, antivirals, antifungals, antiparasites or antigenics within 7 days prior to the visit;\n* Patients with Perennial Allergic Rhinitis (PAR) who are allergic to pet hair (if the subject is currently free of pet hair contact) may be included. PAR subjects who are allergic to other indoor allergens may be included);\n* Have a history of lymphoproliferative diseases, or have had or are present with malignant tumors within 5 years prior to screening (except for skin squamous cell carcinoma in situ, basal cell carcinoma, and cervical carcinoma in situ after thorough treatment without any signs of recurrence);\n* Have a history or evidence of high risk cardiovascular disease\n* Have posterior subcapsular cataracts or glaucoma, or any other eye condition that may affect the evaluation of eye symptoms, or related conditions listed below\n* Active TB infection is present or suspected;\n* Presence or suspected worm infection within 6 months;\n* A history of severe herpes virus infection, such as herpes encephalitis, disseminated herpes, etc.\n* Patients with severe diseases of the central nervous system, respiratory system, liver, kidney, gastrointestinal, urinary, endocrine, or blood systems that the investigator believes may affect the efficacy and safety of the subject;\n* Known or suspected immunosuppressed individuals, including, but not limited to, a history of invasive opportunistic infections (e.g., tuberculosis, histoplasmosis, listeriosis, coccidioidosis, pulmonary cyst disease, aspergillosis), even if the infection has resolved; Or unusual frequent, recurrent, or long-term infections (as determined by the investigator)\n* The presence of any significant laboratory anomalies\n* Pregnant or lactating women, or those with a positive pre-randomized serum pregnancy test\n* According to the judgment of the researcher, it is not suitable to participate in this researcher for other reasons.",{"count":120,"type":21},160,[99,24],"A multicenter, randomized, double-blind, placebo-controlled Phase II\u002FIII seamless clinical study evaluating the efficacy, safety, pharmacokinetic (PK) profile, pharmacodynamic (PD) profile, and immunogenicity of MG-K10 humanized monoclonal antibody injection in the treatment of seasonal allergic rhinitis",[124],"Seasonal Allergic Rhinitis",[126],"Seasonal allergic rhinitis","RECRUITING","2025-04-15",{"date":130,"type":34},"2025-04-18",{"date":132,"type":34},"2025-03-20",{"date":134,"type":21},"2025-09-30",{"name":40,"class":41},{"id":137,"slug":138,"hasResults":11,"nctId":139,"briefTitle":140,"officialTitle":141,"acronym":4,"eligibilityCriteria":142,"healthyVolunteers":11,"sex":16,"minAge":95,"maxAge":143,"enrollmentInfo":144,"targetDuration":4,"studyType":22,"phases":145,"briefSummary":146,"conditions":147,"keywords":149,"overallStatus":127,"whyStopped":4,"lastUpdateSubmitDate":128,"lastUpdatePostDateStruct":151,"startDateStruct":152,"completionDateStruct":154,"leadSponsor":156,"locationsCount":64},"100575965","phase-3-phase-iii-clinical-study-of-mg-k10-humanized-mab-injection-in-subjects-with-prurigo-nodularis-100575965","NCT06779136","Phase III Clinical Study of MG-K10 Humanized Mab Injection in Subjects With Prurigo Nodularis","A Randomized, Double-blind, Placebo-controlled Phase III Study Evaluating the Efficacy and Safety of a Humanized MG-K10 Mab Injection in Subjects With Prurigo Nodularis.","eligibility criteria:\n\n1. voluntarily sign the ICF and comply with all the visits and research-related procedures required by the protocol;\n2. Both men and women were required to be ≥ 18 and ≤ 80 years old at the time of signing the informed consent;\n3. the duration of PN diagnosed by a dermatologist at the time of screening was ≥ 3 months;\n4. In the range of 1-10, WI-NRS≥7 in the past 24 h at screening; WI-NRS in the week before the baseline visit The average weekly score was ≥ 7 points.\n\nExclusion criteria：\n\n1. There are skin diseases other than PN and mild atopic dermatitis (AD) that may interfere with the assessment of research outcomes.\n2. Patients who had a history of moderate to severe AD during the 6 months prior to the screening visit or screening visit.\n3. Receiving potent or super-potent TCS\u002FTCI treatment within 2 weeks before or during screening.\n\n4\\) Evidence of active tuberculosis. 5) Participation in any other clinical study within 12 weeks or 5 half-lives prior to screening","80 Years",{"count":120,"type":21},[24],"A phase III clinical study to evaluate the efficacy and safety of a humanized MG-K10 mab injection in subjects with prurigo nodularis.administered every 4 weeks for 56 weeks.",[148],"Prurigo Nodularis",[150],"Prurigo nodularis",{"date":130,"type":34},{"date":153,"type":34},"2025-02-26",{"date":155,"type":21},"2026-11",{"name":40,"class":41},{"id":158,"slug":159,"hasResults":11,"nctId":160,"briefTitle":161,"officialTitle":162,"acronym":4,"eligibilityCriteria":163,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":164,"targetDuration":4,"studyType":22,"phases":166,"briefSummary":167,"conditions":168,"keywords":170,"overallStatus":127,"whyStopped":4,"lastUpdateSubmitDate":171,"lastUpdatePostDateStruct":172,"startDateStruct":174,"completionDateStruct":176,"leadSponsor":178,"locationsCount":64},"100580486","phase-3-clinical-trial-of-mg-k10-in-stage-iii-of-moderate-to-severe-asthma-100580486","NCT06837922","Clinical Trial of MG-K10 in Stage III of Moderate to Severe Asthma","A Randomized, Double-Blind, Placebo-Controlled Phase III Clinical Trial of the Efficacy and Safety of MG-K10 Humanized Monoclonal Antibody Injection in Adolescent and Adult Patients With Moderate-to-Severe Asthma","Inclusion criteria:\n\n1. Age between 12\\~75 years old (including the critical value), male and female, weight ≥ 30kg;\n2. Diagnosed with asthma for at least 1 year and current disease status that meets the diagnostic criteria of the 2024 GINA guidelines, and:\n\n1\\) Subjects have received moderate-high dose ICS therapy for at least 2 consecutive months before screening (see Appendix 5 for details, fluticasone propionate ≥250 μg twice a day, or an equivalent dose of ICS, no more than 2000 μg\u002Fday or equivalent dose of fluticasone propionate) combined with 1 control drug (such as LABA, LTRA, LAMA or extended-release theophylline), and maintained a stable treatment regimen and dose therapy for ≥ 1 month before baseline. Subjects using the third control drug can also participate in the study, but the subjects must also use the third control drug for at least 2 consecutive months before screening, and maintain a stable treatment regimen and dose treatment ≥ 1 month before baseline; 2) 1-second forced expiratory volume (FEV1) before bronchodilator use at the screening and baseline visits, measured ≤ 80% of the normal predicted value for adults and 90% of the normal predicted value ≤ for adolescents; 3) Asthma Control Questionnaire-5 (ACQ-5) score ≥ 1.5 points at the screening and baseline visits; 4) Must have experienced ≥ 1 acute exacerbation event within 12 months prior to screening: need to receive 1 ≥ systemic glucocorticoids (oral or intravenous) treatment due to asthma exacerbation or need hospitalization\u002Femergency treatment; 5）A positive bronchodilator test (a ≥12% increase in FEV1 after inhalation of bronchodilators and an absolute increase in FEV1 ≥200 mL) will be acceptable for bronchodilator test results within 24 months prior to screening； Positive bronchodilator test (after inhaling a bronchodilator, the forced expiratory volume in one second (FEV1) increases by ≥12%, and the absolute value of FEV1 increases by ≥200 mL). The results of the bronchodilator test conducted within 24 months before screening are acceptable.\n\n3.The subjects (including adolescents aged 12 years old ≤ age \\\u003C 18 years old) agree that they themselves and their partners will adopt effective contraceptive measures from the signing of the Informed Consent Form (ICF) until 6 months after the last administration of the drug.\n\n4.The subject and his\u002Fher guardian (applicable to adolescents aged 12 years old ≤ age \\\u003C 18 years old) are able to understand the procedures and methods of this study, willing to sign the Informed Consent Form, strictly abide by the clinical research protocol to complete the study, and capable of independently completing the study-related questionnaires.\n\nExclusion criteria:\n\n1. Subjects with known hypersensitivity to the investigational product or its excipients;\n2. Subjects who, within 1 month prior to screening and drug administration, have required systemic glucocorticoid therapy (oral or intravenous) for asthma exacerbation at least once, or have required hospitalization\u002Femergency treatment due to asthma exacerbation.\n3. Subjects who, within 1 month prior to screening and drug administration, have required at least one course of systemic glucocorticoid therapy (oral or intravenous administration) for asthma exacerbation, or have required hospitalization or emergency treatment due to asthma exacerbation.\n4. Subjects who have received systemic glucocorticoid therapy from 1 month before screening until drug administration (excluding those with topical, ophthalmic, or intranasal glucocorticoid use)\n5. Subjects who have received intravenous immunoglobulin (IVIG) therapy or allergen-specific immunotherapy (SIT) within 1 month prior to drug administration.\n6. Subjects who have undergone major surgery within 8 weeks prior to screening have scheduled major surgery during the study period, including inpatient and day-case outpatient procedures.\n7. Subjects with a history of substance abuse or illicit drug use.\n8. Subjects with any other conditions that, in the investigator's judgment, may compromise subject safety or trial integrity.",{"count":165,"type":21},504,[24],"A randomized, double-blind, placebo-controlled Phase III clinical trial on the efficacy and safety of MG-K10 humanized monoclonal antibody injection in adolescent and adult patients with moderate to severe asthma.",[169],"Asthma",[169],"2025-04-11",{"date":173,"type":34},"2025-04-17",{"date":175,"type":34},"2025-03-25",{"date":177,"type":21},"2028-01-15",{"name":40,"class":41},{"id":180,"slug":181,"hasResults":11,"nctId":182,"briefTitle":183,"officialTitle":184,"acronym":4,"eligibilityCriteria":185,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":95,"enrollmentInfo":186,"targetDuration":4,"studyType":22,"phases":188,"briefSummary":190,"conditions":191,"keywords":192,"overallStatus":127,"whyStopped":4,"lastUpdateSubmitDate":193,"lastUpdatePostDateStruct":194,"startDateStruct":196,"completionDateStruct":198,"leadSponsor":200,"locationsCount":64},"100574878","phase-1-ibiia-study-of-mg-k10-in-adolescent-moderately-severe-patients-100574878","NCT06765005","IB\u002FIIa Study of MG-K10 in Adolescent Moderately Severe Patients","A Phase Ib\u002FII.a Clinical Study of the Safety, Pharmacokinetics and Preliminary Efficacy of MG-K10Humanized Monoclonal Antibody Injection in Adolescent Patients with Moderate to Severe Atopic Dermatitis Aged 12-18 Years.","Inclusion Criteria:\n\n1. 12 years old ≤ \\\u003C18 years old (based on the date of signing the ICF), regardless of gender.\n\n   Body weight ≥ 30 kg;\n2. patients with a diagnosis of AD that meets the American Academy of Dermatology Consensus Criteria (2014), with a diagnosis of AD or history of eczema ≥6 months prior to screening, and with the following criteria\n\n2\\. Patients with a diagnosis of AD that meets the American Academy of Dermatology Consensus Criteria (2014), a history of AD or eczema ≥ 6 months prior to screening, and the following criteria:\n\n* EASI ≥16 at screening and baseline;\n* EASI ≥16 at Screening and Baseline; IGA ≥3 at Screening and Baseline;\n* BSA involvement in skin lesions ≥10% at Screening and Baseline; 3. determined within 6 months prior to Screening to be inadequately treated with topical medications or medically inappropriate for treatment with topical medications; andmedically inappropriate for treatment with topical medications (e.g., significant side effects or safety risks).\n\n  (e.g., significant side effects or safety risks);\n\nInadequate efficacy is defined as:\n\n\\- At least 4 weeks of potent or 2 weeks of ultra-potent topical glucocorticosteroids or 4 weeks of topical calcitonin within 6 months prior to Screening.Inadequate treatment outcome is defined as or maintain a state of remission or low disease activity (equivalent to an IGA score of 0 \\[=(equivalent to an IGA score of 0 \\[= asymptomatic\\] - 2 \\[= mildly symptomatic\\]);- Important side effects or safety risks are those that, as assessed by the investigator or the patient's treating physician, outweigh the potential therapeutic benefit.Important side effects or safety risks are those that, as assessed by the investigator or the patient's treating physician, outweigh the potential therapeutic benefit, including treatment intolerance Important side effect or safety risk means a side effect or risk that outweighs the potential therapeutic benefit, as assessed by the Investigator or the patient's treating physician, including treatment intolerance, allergic reaction, significant skin atrophy, and systemic reaction。 4. Subjects of potential reproductive potential (e.g., women who have had their first menstruation or men who have had spermatozoa) must agree to and comply with the use of effective contraception throughout the study period and for 6 months after the last dose.Subjects of potential reproductive potential (e.g., women who have had their first period or men who have had spermatozoa) must agree to and comply with effective contraception throughout the study period and for 6 months after the last dose.\n\n5\\. the subject and\u002For the subject's parent or other legal guardian voluntarily signs a written informed consent form and is able to communicate with the investigator.\n\nSubjects and\u002For their parents or other legal guardians voluntarily sign a written informed consent form and are able to communicate well with the investigator and comply with protocol requirements for follow-up visits.\n\nExclusion Criteria:\n\n1. Individuals with severe allergic reactions to the test drug or its analogs; those who cannot administer subcutaneous injections, e.g., those on anticoagulant therapy, known bleeding disorders, or idiopathic thrombocytopenic purpura;\n2. Presence of other active skin conditions (e.g., psoriasis or lupus erythematosus) that may affect AD evaluation;\n3. Presence of diseases that may require systemic hormonal or immunosuppressive therapy;\n4. Patients with ocular disease that, in the judgment of the investigator, is not appropriate for enrollment, such as a previous history of atopic keratoconjunctivitis with involvement of the cornea; an ophthalmologist will be required to make a diagnosis if the investigator is unable to make a determination;\n5. Use of targeted inhibitors (e.g., JAK inhibitors), systemic glucocorticoids, cyclosporine, or other immunosuppressants (e.g., methotrexate) within 4 weeks prior to randomization systemic glucocorticoids, cyclosporine or other immunosuppressive agents (e.g., methotrexate, mycophenolate mofetil, azathioprine, etc.), phosphodiesterase (PDE4) inhibitors, ultraviolet (UV) radiation, and other immunosuppressive agents.\n\n   Systemic glucocorticoids, cyclosporine or other immunosuppressants (e.g., methotrexate, mycophenolate mofetil, and azathioprine), phosphodiesterase (PDE4) inhibitors, ultraviolet radiation therapy, systemic AD Cyclosporine or other immunosuppressants (methotrexate, mycophenolate mofetil, and azathioprine), phospholipase (PDE4) inhibitors, ultraviolet radiation therapy, and systemic herbal medicine for AD Have used a biologic within 10 weeks prior to randomization or have not exceeded 5 half-lives (whichever is longer).\n\n   have used a biologic agent within 10 weeks prior to randomization or have not exceeded 5 half-lives, whichever is longer;)\n\n   -Allergen-specific immunotherapy in the 6 months prior to randomization;\n6. Those who stopped all topical medications for less than 2 weeks prior to randomization, including topical glucocorticoids, topical calcium-modulated phosphatase inhibitors, antibiotic-complexed creams, and topical herbal treatments;\n7. Participated in a clinical study with a biologic within 3 months or 5 half-lives, whichever is longer, prior to screening; participated in a clinical study with a biologic within 1 month or 5 half-lives, whichever is longer, prior to randomization.\n\n   Participated in a clinical study with a biologic agent within 3 months or 5 half-lives, whichever is longer, prior to screening; participated in a clinical study with a non-biologic agent within 1 month or 5 half-lives, whichever is longer, prior to randomization.\n\n   Participated in a clinical study of a non-biologic agent drug within 1 month or 5 half-lives, whichever is longer, prior to randomization, or plans to participate in a clinical study of another drug during the study period.\n\n   Participated in a clinical study of a non-biologic agent drug within 1 month or 5 half-lives, whichever is longer, prior to randomization, or plan to participate in a clinical study of another drug during the study period.\n\n   Subjects who have participated in a clinical study of this product; subjects who have used monoclonal antibodies to the interleukin 4 receptor alpha subunit (IL-4Rα) and, in the judgment of the investigator, have developed resistance or serious drug-related AEs.\n\n   Subjects who, in the judgment of the Investigator, have developed drug resistance or severe drug-related AEs;\n8. Those who have received live\u002Flive attenuated vaccine within 3 months prior to screening or plan to do so during the study;\n9. Persons with chronic active infections or acute infections requiring systemic (oral and intravenous) antipathogenic microbial (anti-bacterial, viral, fungal, etc.) therapy within 4 weeks prior to randomization;\n10. Evidence of active tuberculosis or previous evidence of active tuberculosis without appropriate documented treatment; active tuberculosis infection as indicated by chest X-ray (frontal and lateral) or CT, etc., within 3 months prior to\u002Fscreening period;\n11. History of parasitic infection within 6 months prior to screening;\n12. Patients with a history of malignant tumors;\n13. Comorbidities of other serious diseases, including but not limited to cardiovascular, metabolic, and neurological diseases, which are assessed by the investigator to be unsuitable for immunosuppressive therapy;\n14. Those who, in the opinion of the investigator, have other conditions that make them unsuitable for participation in the study;\n15. History of alcohol or drug abuse within 6 months prior to screening;",{"count":187,"type":21},24,[189,99],"PHASE1","This study was designed to reflect the safety pharmacokinetics and preliminary efficacy of MG-K10 Humanized Monoclonal Antibody Injection in adolescent patients 12-18 weeks of age with moderate to severe atopic dermatitis, administered every 2 or 4 weeks for 8 weeks",[78],[78],"2025-01-02",{"date":195,"type":34},"2025-01-09",{"date":197,"type":34},"2024-07-19",{"date":199,"type":21},"2025-07",{"name":40,"class":41},""]