[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Shanghai Jiaolian Drug Research and Development Co., Ltd\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":142},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,6,0,[8,42,62,82,104,123],{"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":26,"conditions":27,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":31,"startDateStruct":34,"completionDateStruct":36,"leadSponsor":38,"locationsCount":41},"100550997","phase-2-a-clinical-study-of-b007-in-the-treatment-of-pemphigus-100550997",false,"NCT06454357","A Clinical Study of B007 in the Treatment of Pemphigus.","A Phase II\u002FIII Clinical Study to Evaluate the Efficacy and Safety of B007 in Subjects With Pemphigus.","Inclusion Criteria:\n\n1. Subjects who voluntarily participate in this study and sign informed consent form;\n2. Subjects who meet the clinical manifestations of pemphigus and are clinically diagnosed as prescribed diseases;\n3. Subjects with first diagnosis or relapse;\n4. Subjects who have the ability to follow the study protocol as determined by the investigator.\n\nExclusion Criteria:\n\n1. Subjects diagnosed with prescribed diseases;\n2. Since the diagnosis of pemphigus, Disease duration\\>4 years;\n3. Subjects using prescribed drugs;\n4. Presence of a specified disease or history of disease;\n5. The subjects has prescribed examination abnormalities that are assessed as unsuitable for participation in the study by the investigator;\n6. A history of severe allergy or allergic reaction to human or mouse monoclonal antibodies; known contraindications to orally prescribed drugs;\n7. Subjects who participate in another interventional clinical trial at a specified time before randomization;\n8. Subjects who received live vaccine at the specified time before the first dose and are expected to receive the vaccine at the specified time after the last dose;\n9. Pregnant and lactating women;\n10. Fertile female subjects do not agree to use effective contraception from signing the informed consent form to the prescribed time after the last dose.\n\n    Women who are considered fertile by the investigator must have negative serum pregnancy tests before starting the drug;\n11. Sexually active male subjects who do not intend to use an effective contraceptive method during the trial period or within specified time after the last dose, or male subjects who plan to donate sperm at a specified time during the trial or after the last dose.\n12. Other conditions deemed unsuitable for participation in this study by the researchers.","ALL","18 Years","75 Years",{"count":20,"type":21},132,"ESTIMATED","INTERVENTIONAL",[24,25],"PHASE2","PHASE3","The purpose of this study is to evaluate the efficacy and safety of B007 in subjects with pemphigus.",[28],"Pemphigus","RECRUITING","2026-04-29",{"date":32,"type":33},"2026-05-05","ACTUAL",{"date":35,"type":33},"2024-07-12",{"date":37,"type":21},"2026-12-31",{"name":39,"class":40},"Shanghai Jiaolian Drug Research and Development Co., Ltd","INDUSTRY",12,{"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":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":56,"startDateStruct":57,"completionDateStruct":59,"leadSponsor":60,"locationsCount":61},"100552215","phase-2-a-clinical-study-of-b007-in-the-treatment-of-primary-membranous-nephropathy-100552215","NCT06470191","A Clinical Study of B007 in the Treatment of Primary Membranous Nephropathy.","A Multicenter, Randomized, Controlled, Open Phase II\u002FIII Clinical Study to Evaluate the Efficacy and Safety of B007 Versus Cyclosporine in the Treatment of Primary Membranous Nephropathy.","Inclusion Criteria:\n\n1. Subjects with primary membranous nephropathy pathologically confirmed by renal biopsy;\n2. Subjects with glomerular filtration rate（eGFR） ≥ 45 mL\u002Fmin\u002F1.73 m2.\n3. If taking Angiotensin converting enzyme inhibitors\u002Fangiotensin II receptor antagonists\u002Fsodium-glucose cotransporter 2 inhibitors\u002Fendothelin inhibitors, a stable dose within 4 weeks before randomization;\n4. Subjects with 24-hour elevated urinary protein in accordance with the prescribed conditions;\n5. Subjects whose laboratory test results meet the prescribed standards during the screening period;\n6. Subjects who have fully understood this study and voluntarily signed the informed consent form；\n7. Subjects who are able to follow the study protocol as judged by the investigator.\n\nExclusion Criteria:\n\n1. Subjects with secondary membranous nephropathy or primary membranous nephropathy whose pathological reports suggest concomitant crescent bodies;\n2. Subjects identified by the investigator as previously resistant to CD20 monoclonal antibody or cyclosporine;\n3. Subjects who have received medication prescribed for membranous nephropathy;\n4. Subjects with concomitant prescribed diseases;\n5. Subjects with a known history of severe allergic reactions to humanized monoclonal antibodies, or known allergies to any component of cyclosporine or B007;\n6. Subjects who received live vaccination, major surgery, or participated in other clinical trials within 28 days before receiving the study drug;\n7. Subjects with positive hepatitis B surface antigen; those with positive hepatitis C virus antibody; those with a history of immunodeficiency or suffer from other acquired or congenital immunodeficiency diseases;\n8. Subjects who have a clear history of tuberculosis or have received anti-tuberculosis treatment;\n9. Subjects with CD4+ T lymphocyte count \\\u003C 400 cells\u002FμL;\n10. Pregnant or lactating women; women of childbearing potential who have not been sterilized do not agree to use appropriate contraceptive measures during treatment and for at least 12 months after the last dose of the study drug;\n11. For male subjects who have not been sterilized: those who do not consent to the use of barrier contraception during the study period and for at least 12 months after the last administration of the study drug, and who do not consent to the use of other contraceptive methods by their spouses;\n12. Other conditions unsuitable for participation in this study determined by the Investigator.","80 Years",{"count":51,"type":21},216,[24,25],"To evaluate the efficacy and safety of B007 in the Treatment of Primary Membranous Nephropathy",[55],"Primary Membranous Nephropathy",{"date":32,"type":33},{"date":58,"type":33},"2024-07-30",{"date":37,"type":21},{"name":39,"class":40},21,{"id":63,"slug":64,"hasResults":11,"nctId":65,"briefTitle":66,"officialTitle":67,"acronym":4,"eligibilityCriteria":68,"healthyVolunteers":11,"sex":69,"minAge":17,"maxAge":18,"enrollmentInfo":70,"targetDuration":4,"studyType":22,"phases":72,"briefSummary":73,"conditions":74,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":76,"startDateStruct":77,"completionDateStruct":79,"leadSponsor":80,"locationsCount":81},"100549483","phase-2-a-study-of-b013-in-combination-with-paclitaxel-in-patients-with-platinum-resistant-recurrent-ovarian-cancer-100549483","NCT06434610","A Study of B013 in Combination With Paclitaxel in Patients With Platinum-resistant Recurrent Ovarian Cancer.","A Multicenter, Randomized, Double-blind, Parallel-controlled Phase II Clinical Trial to Evaluate the Efficacy and Safety of B013 Combined With Paclitaxel in the Treatment of Platinum-resistant Recurrent Ovarian Cancer, Fallopian Tube Cancer, or Primary Peritoneal Cancer.","Inclusion Criteria:\n\n1. Subjects who voluntarily participate in this study and sign informed consent form;\n2. Ovarian cancer, fallopian tube cancer or primary peritoneal cancer confirmed by histopathological examination and meeting the criteria for platinum resistance recurrence;\n3. ECOG performance status of 0 or 1；\n4. Expected survival \\> 12 weeks;\n5. The subject has at least one measurable lesion;\n6. Normal function of major organs;\n7. The fertile subjects agree to use reliable contraception from signing the informed consent to at least 6 months after the last dose.\n\nExclusion Criteria:\n\n1. Subjects who have received prescribed treatment previously;\n2. Subjects who are still using anti-tumor traditional Chinese patent medicines at the time of signing informed consent;\n3. Subjects with known central nervous system metastasis and multiple bone metastasis;\n4. Subjects who had clinical symptoms of pleural effusion, pericardial effusion or ascites before randomization and needed puncture drainage, or had received puncture drainage within the previous 2 weeks;\n5. Have a history of other malignant tumors within 5 years before signing the informed consent;\n6. Subjects with prescribed cardiovascular diseases;\n7. Subjects with infections requiring intravenous antibiotic infusion within 2 weeks prior to randomization;\n8. Had severe lung disease before randomization;\n9. Before randomization, the peripheral nerve toxicity of previous anti-tumor treatment was \\> grade 2, and other reversible toxicity was \\> grade 1;\n10. Subjects who had undergone surgery within 28 days prior to randomization and did not recover from adverse effects of surgery;\n11. Subjects who participated in clinical trials within 30 days prior to randomization and received other unmarketed investigational drugs;\n12. Subjects who are known to be allergic to any component of B013 or paclitaxel.\n13. Subjects with a known history of substance abuse, alcohol or drug use; Subjects with a known history of neurological or psychiatric disorders;\n14. Female subjects who are pregnant or breastfeeding;\n15. Other situations determined by the researchers and\u002For sponsors as unsuitable for participation in this trial.","FEMALE",{"count":71,"type":21},90,[24],"To evaluate the efficacy and safety of B013 in patients with platinum-resistant recurrent ovarian cancer.",[75],"Platinum-resistant Recurrent Ovarian Cancer",{"date":32,"type":33},{"date":78,"type":33},"2024-07-11",{"date":37,"type":21},{"name":39,"class":40},17,{"id":83,"slug":84,"hasResults":11,"nctId":85,"briefTitle":86,"officialTitle":87,"acronym":4,"eligibilityCriteria":88,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":89,"enrollmentInfo":90,"targetDuration":4,"studyType":22,"phases":92,"briefSummary":93,"conditions":94,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":96,"startDateStruct":98,"completionDateStruct":100,"leadSponsor":102,"locationsCount":103},"100550478","phase-2-a-clinical-study-of-b007-in-the-treatment-of-generalized-myasthenia-gravis-100550478","NCT06447597","A Clinical Study of B007 in the Treatment of Generalized Myasthenia Gravis.","A Randomized, Double-blind, Placebo-controlled, Multicenter Phase II\u002FIII Clinical Study to Evaluate the Efficacy and Safety of B007 in Subjects With Generalized Myasthenia Gravis","Inclusion Criteria:\n\n1. Sign informed consent form;\n2. Subjects with generalized myasthenia gravis;\n3. Serum AchR(Acetylcholine receptor)-Ab or MUSK-Ab was positive during screening;\n4. MG-ADL ≥5 at screening and baseline;\n5. Before randomization, subjects received at least one gMG stable dose of SoC, and maintain a stable dose throughout the test;\n6. Subjects agree to use effective contraceptive methods for contraception from signing the informed consent form to 1 year after the last dose. Female subjects considered fertile by the investigator must have negative serum pregnancy tests before the first dose.\n\nExclusion Criteria:\n\n1. Subjects with MGFA I and V type;\n2. Subjects usingprescribed drugs;\n3. Subjects with a prescribed disease or history of disease;\n4. The subjects has prescribed examination abnormalities that are assessed as unsuitable for participation in the study by the investigator;\n5. Known history of severe allergic reaction to humanized monoclonal antibodies, or known allergy to any component of B007;\n6. Subjects who received live vaccine at the specified time before the first dose and are expected to receive the vaccine at the specified time after the last dose;\n7. Subjects who have received major surgery or participated in other clinical trials within the prescribed time before screening;\n8. Pregnant and lactating women;\n9. Fertile female subjects do not agree to use effective contraception from signing the informed consent form to 1 years after the last dose.\n10. Sexually active male subjects who do not intend to use an effective contraceptive method during the trial period or within1 years after the last dose, or male subjects who plan to donate sperm during the trial or within 1 year after the last dose;\n11. A history of alcohol or drug abuse within the past 12 months;\n12. Other conditions deemed unsuitable for participation in this study by the researchers.","70 Years",{"count":91,"type":21},104,[24,25],"The purpose of this study is to evaluate the efficacy and safety of B007 in subjects with generalized myasthenia gravis.",[95],"Generalized Myasthenia Gravis",{"date":97,"type":33},"2026-04-30",{"date":99,"type":33},"2024-07-01",{"date":101,"type":21},"2026-06-30",{"name":39,"class":40},18,{"id":105,"slug":106,"hasResults":11,"nctId":107,"briefTitle":108,"officialTitle":109,"acronym":4,"eligibilityCriteria":110,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":111,"targetDuration":4,"studyType":22,"phases":112,"briefSummary":113,"conditions":114,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":116,"startDateStruct":117,"completionDateStruct":119,"leadSponsor":121,"locationsCount":122},"100547875","phase-2-a-clinical-study-of-b001-injection-in-the-treatment-of-neuromyelitis-optica-spectrum-disordersnmosd-100547875","NCT06413654","A Clinical Study of B001 Injection in the Treatment of Neuromyelitis Optica Spectrum Disorders(NMOSD)","A Multicenter, Randomized, Double-blind, Placebo-controlled Phase II\u002FIII Clinical Study to Evaluate the Efficacy and Safety of B001 Injection in Aquaporin-4 Antibody Positive Patients With Neuromyelitis Optica Spectrum Disorder","Inclusion Criteria:\n\n1. Confirmed NMOSD patients;\n2. Experienced at least 1 recurrence of NMOSD within 1 year or at least 2 recurrence within 2 years prior to screening;\n3. The blood pregnancy tests were negative within 7 days before the first dose in fertile female subjects. The fertile subjects and the male subjects whose partner are fertile woman agree to use reliable contraception during the study period and within 6 months after the study drug discontinuation;\n4. Volunteer to participate in clinical research; Fully understand and know the study and sign the informed consent; Willing to follow and able to complete all test procedures.\n\nExclusion Criteria:\n\n1. Subjects with severe NMOSD were judged by the researcher to be unfit to participate in this study;\n2. Subjects with chronic active immune system diseases undergoing systematic treatment;\n3. Received anti-CD20 or other cell depletion therapy within 6 months before first dose;\n4. Received the prescribed drug treatment at the prescribed time before first dose;\n5. Subjects who have participated in any drug clinical trials within 28 days prior to the first dose;\n6. Received hematopoietic stem cell transplantation、 lymphatic irradiation before first dose;\n7. Pregnant or lactating women; Subjects with birth plans during the trial;\n8. Subjects who had undergone major surgery within 2 months prior to screening or were scheduled to undergo major surgery during the trial;\n9. Subjects with severe, progressive, or uncontrolled disease who have been assessed by the investigator to be at increased risk of participating in the study;\n10. A history of gastrointestinal perforation and\u002For fistula within 6 months prior to screening;\n11. Subjects who received a live or attenuated vaccine within 4 weeks prior to initial administration, or who plan to receive vaccination during the study period;\n12. Subjects with severe or persistent infection currently or within the 1 months prior to screening;\n13. Subjects with positive gamma interferon release test;\n14. Subjects who currently have active hepatitis or have a history of severe liver disease;\n15. Uncontrolled systemic disease, or any other reason the investigator deems inappropriate for inclusion;\n16. Abnormal laboratory test results;\n17. Subjects with a history of alcohol or drug abuse in the 6 months prior to screeing, or who are abusing;\n18. Subjects with symptoms of severe mental illness who are clinically uncooperative;\n19. Subjects who were unable to undergo magnetic resonance imaging during the study and who had other conditions that the investigator considered inappropriate to enroll.",{"count":20,"type":21},[24,25],"To evaluate the efficacy and safety of B001 injection in aquaporin-4 antibody positive patients with neuromyelitis optica spectrum disorder.",[115],"Neuromyelitis Optica Spectrum Disorders",{"date":32,"type":33},{"date":118,"type":33},"2024-07-17",{"date":120,"type":21},"2029-02-28",{"name":39,"class":40},51,{"id":124,"slug":125,"hasResults":11,"nctId":126,"briefTitle":127,"officialTitle":128,"acronym":4,"eligibilityCriteria":129,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":130,"targetDuration":4,"studyType":22,"phases":132,"briefSummary":134,"conditions":135,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":136,"startDateStruct":137,"completionDateStruct":139,"leadSponsor":141,"locationsCount":5},"100490613","phase-1-a-phase-i-clinical-study-of-recombinant-humanized-anti-cd20b-lymphocyte-antigen-cd20-monoclonal-antibody-subcutaneous-injection-in-the-treatment-of-primary-membranous-nephropathy-100490613","NCT05668403","A Phase I Clinical Study of Recombinant Humanized Anti-CD20(B-lymphocyte Antigen CD20) Monoclonal Antibody Subcutaneous Injection in the Treatment of Primary Membranous Nephropathy","A Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Profiles and Preliminary Efficacy of Subcutaneous Injection of Recombinant Humanized Anti-CD20 Monoclonal Antibody in the Treatment of Primary Membranous Nephropathy","Inclusion Criteria:\n\n1. Subjects who have fully understood this study and voluntarily signed the informed consent form;\n2. Male or female subjects, aged between 18 and 75 years;\n3. Subjects with primary membranous nephropathy pathologically confirmed by renal biopsy;\n4. Subjects with systolic blood pressure ≤ 140 mmHg and diastolic blood pressure ≤ 90 mmHg at screening;\n5. If taking ACEI(Angiotensin converting enzyme inhibitors), ARB(Angiotensin receptor blocker), a stable dose within 4 weeks before screening is required;\n6. Subjects who are able to follow the study protocol as judged by the investigator.\n\nExclusion Criteria:\n\n1. Subjects with secondary membranous nephropathy;\n2. Subjects with uncontrolled blood pressure as judged by the investigator within 3 months before screening;\n3. Subjects with decreases in urine protein ≥ 50% within 6 months before screening;\n4. Subjects who have received or are receiving renal replacement therapy;\n5. Subjects with type 1 diabetes mellitus, or those with type 2 diabetes mellitus who are diagnosed as diabetic nephropathy by percutaneous renal biopsy;\n6. Subjects who have a clear history of tuberculosis or have received anti-tuberculosis treatment;\n7. Subjects with active bacterial, viral, fungal, mycobacterial, parasitic or other infections requiring systemic antibiotics or antiviral therapy;\n8. Subjects with known history of severe allergic reactions to humanized monoclonal antibodies；\n9. Subjects who received live vaccination, major surgery, or participated in other clinical trials within 28 days before receiving the study drug;\n10. Pregnant or lactating women; women of childbearing potential who have not been sterilized do not agree to use appropriate contraceptive measures during treatment and for at least 12 months after the last dose of the study drug;\n11. Subjects with serious, progressive, or uncontrolled disease that may increase risks during the participation in the study as assessed by the investigator;\n12. Subjects with a history of alcoholism or drug abuse within 12 months;\n13. Subjects with positive hepatitis B surface antigen; those with positive hepatitis C virus antibody; those with a history of immunodeficiency;\n14. Subjects with CD4+ T lymphocyte count \\\u003C 300 cells\u002FμL;\n15. Other conditions unsuitable for participation in this study determined by the Investigator.",{"count":131,"type":21},52,[133],"PHASE1","This Phase I Clinical Study assessed the Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Profiles and Preliminary Efficacy of Subcutaneous Injection of Recombinant Humanized Anti-CD20 Monoclonal Antibody in the Treatment of Primary Membranous Nephropathy",[55],{"date":97,"type":33},{"date":138,"type":33},"2023-03-02",{"date":140,"type":21},"2027-12-30",{"name":39,"class":40},""]