[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Guangdong Hengrui Pharmaceutical Co., Ltd\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":470},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,22,0,[8,41,64,86,106,127,146,167,188,209,231,251,270,289,310,330,349,371,392,412,432,452],{"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":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":30,"startDateStruct":33,"completionDateStruct":35,"leadSponsor":37,"locationsCount":40},"100643516","phase-2-a-clinical-trial-to-evaluate-the-efficacy-and-safety-of-hrs-9821-inhalation-suspension-in-patients-with-moderate-to-severe-chronic-obstructive-pulmonary-disease-100643516",false,"NCT07640451","A Clinical Trial to Evaluate the Efficacy and Safety of HRS-9821 Inhalation Suspension in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease","A Multicenter, Randomized, Double-blind, Placebo-controlled Phase II Clinical Trial to Evaluate the Efficacy and Safety of HRS-9821 Inhalation Suspension in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease","Inclusion Criteria:\n\n1. Age ≥ 40 years old and \\\u003C 80 years old, male or female.\n2. Meet the weight standard.\n3. Smoking history ≥ 10 pack-years.\n4. COPD has been diagnosed ≥ 1 year.\n5. 4 weeks before screening, the background treatment for COPD was stable.\n6. FEV1\u002FFVC \\\u003C 0.7, 30% ≤ FEV1 ≤ 80%.\n7. mMRC score ≥ 2.\n8. The inspection and medication can be completed as required.\n9. Non-pregnant and breastfeeding state.\n10. Able and willing to provide a written informed consent.\n\nExclusion Criteria:\n\n1. History of life-threatening COPD.\n2. Other pulmonary diseases that may affect the efficacy evaluation of this study.\n3. Concurrent diseases other than COPD that may affect lung function.\n4. History of asthma.\n5. Pulmonary heart disease requiring clinical intervention, or moderate to severe pulmonary hypertension.\n6. Malignant tumors within 5 years.\n7. Uncontrolled severe cardiovascular and cerebrovascular diseases within 1 year.\n8. Unstable diseases.\n9. Acute exacerbation of COPD within 12 weeks, hospitalization for COPD or pneumonia within 6 months.\n10. Infection in the lungs or other parts occurs within 16 weeks and requires treatment.\n11. Immunosuppression.\n12. Uncontrolled hypertension.\n13. Lung resection, surgical lung volume reduction or endoscopic treatment for COPD.\n14. Undergone major surgery or planned surgery within 14 months.\n15. Abnormal chest images have clinical significance.\n16. Tuberculosis infection requiring treatment within 16 to 12 months.\n17. Virological test result was positive.\n18. Laboratory blood tests and electrocardiograms were significantly abnormal.\n19. Requires oxygen inhalation or intermittent oxygen inhalation therapy.\n20. Hypercapnia, using or requiring long-term use of any non-invasive positive pressure ventilation device.\n21. Biological agents that may have therapeutic effects on the studied disease have been used within 12 weeks or within 5 half-lives of the drug.\n22. Vaccination, theophylline or drugs within 4 weeks.\n23. Having participated in other clinical studies within 4 weeks and used research drugs or medical devices containing active ingredients, or still within 5 half-lives of the research drug.\n24. Systemic glucocorticoids, immunosuppressants, and oral Roflumilast within 12 weeks.\n25. Undergoing or planning rehabilitation treatment for pulmonary rehabilitation.\n26. Non-selective β blockers within 1 week.\n27. Overly potent\u002Fmoderately potent drugs that inhibit or induce the liver drug-metabolizing enzyme CYP3A4 within 14 days.\n28. Allergic to the research drug or salbutamol or excipients.\n29. Has been used HRS-9821.\n30. Drug abuse and alcohol abuse within 1 year.\n31. Pregnant or lactating period or planning to be pregnant or lactating.\n32. The researchers judged that there were other unsuitable circumstances.","ALL","40 Years","80 Years",{"count":20,"type":21},90,"ESTIMATED","INTERVENTIONAL",[24],"PHASE2","The study is being conducted to evaluate the efficacy and safety of HRS-9821 for patients with COPD, and to explore the reasonable dosage of HRS-9821 for patients with COPD.",[27],"COPD","NOT_YET_RECRUITING","2026-06-05",{"date":31,"type":32},"2026-06-10","ACTUAL",{"date":34,"type":21},"2026-06",{"date":36,"type":21},"2026-11",{"name":38,"class":39},"Guangdong Hengrui Pharmaceutical Co., Ltd","INDUSTRY",1,{"id":42,"slug":43,"hasResults":11,"nctId":44,"briefTitle":45,"officialTitle":46,"acronym":4,"eligibilityCriteria":47,"healthyVolunteers":11,"sex":16,"minAge":48,"maxAge":49,"enrollmentInfo":50,"targetDuration":4,"studyType":22,"phases":52,"briefSummary":53,"conditions":54,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":56,"lastUpdatePostDateStruct":57,"startDateStruct":59,"completionDateStruct":60,"leadSponsor":62,"locationsCount":63},"100638778","phase-2-a-phase-ii-study-of-shr-2173-injection-in-patients-with-myasthenia-gravis-100638778","NCT07622342","A Phase II Study of SHR-2173 Injection in Patients With Myasthenia Gravis","A Phase II, Randomized, Double-Blind, Placebo-Controlled Clinical Trial to Evaluate the Efficacy and Safety of SHR-2173 in Patients With Generalized Myasthenia Gravis","Inclusion Criteria:\n\n1. Male and female participants aged 18-75 years, confirmed diagnosis of generalized myasthenia gravis (gMG) (Myasthenia Gravis Foundation of America \\[MGFA\\] class II-IV).\n2. Positive for anti-AChR antibody or anti-MuSK antibody.\n3. MG-ADL total score ≥5 at screening and baseline, with \\>50% of the score attributable to non-ocular items.\n4. QMG score ≥11 at screening and baseline.\n5. Maintenance on stable standard of care (SOC) therapy.\n6. No contraindication to at least one rescue therapy: IVIg or PLEX.\n7. Provided written informed consent (ICF) after full understanding of the study content, procedures, and potential adverse reactions.\n8. Female subjects with fertility or male participants whose partners are women of childbearing age must avoid donating sperm\u002Feggs from the date of signing the ICF until 12 weeks after the last study medication, and agree to take contraceptive measures as specified in the protocol\n\nExclusion Criteria:\n\n1. Presence of any of the following medical histories or comorbidities:\n\n   1. Any untreated thymic epithelial tumor, mediastinal germ cell tumor, or other malignant mediastinal mass; or any thymic cyst or other mass requiring immediate intervention per investigator judgment;\n   2. Previous history of thymic tumor not meeting protocol requirements;\n   3. Myasthenic crisis (MGFA Class V) within 3 months prior to randomization;\n   4. Any known disease other than gMG that may interfere with study procedures and assessments;\n   5. A history of progressive multifocal leukoencephalopathy (PML);\n   6. A history of body irradiation or organ transplantation.\n2. Use of any of the following drugs\u002Ftreatments or participation in a clinical study:\n\n   1. Prior treatment with CAR-T or other cellular therapy, or T-cell engager (TCE) therapy;\n   2. Anti-CD20 monoclonal antibody within 6 months prior to randomization; other B-cell or plasma cell-depleting therapy within 6-12 months prior to randomization;\n   3. Alkylating agent within 12 weeks prior to randomization;\n   4. Any biologic for MG treatment within 12 weeks prior to randomization;\n   5. Neonatal Fc receptor antagonist therapy within 8 weeks prior to randomization;\n   6. Janus kinase (JAK), Bruton tyrosine kinase (BTK), or tyrosine kinase 2 (TYK2) inhibitor within 12 weeks prior to randomization;\n   7. IVIg, subcutaneous immunoglobulin, or PLEX therapy within 4 weeks prior to randomization;\n   8. Live\u002Fattenuated live vaccine within 4 weeks prior to randomization, or planned vaccination during the study.\n3. A history of malignancy within 5 years prior to screening;\n4. Infection-related medical history and examinations:\n\n   1. A history of herpes zoster meeting any of the following: 1) A history of disseminated herpes zoster, herpes zoster encephalitis, or ocular herpes zoster involving the retina; 2) Recurrent herpes zoster with 2 or more episodes within 2 years; 3) Herpes zoster infection not fully resolved within 12 weeks prior to screening;\n   2. A history of tuberculosis (TB) or latent TB infection;\n   3. A known history of primary immunodeficiency, splenectomy, or any underlying condition predisposing to infection;\n   4. A history of recurrent infections requiring hospitalization and intravenous antibiotics;\n   5. Any infection requiring hospitalization and\u002For intravenous antimicrobial therapy within 8 weeks prior to randomization, or any infection requiring oral antimicrobial therapy within 2 weeks prior to randomization;\n   6. Positive test result for hepatitis B surface antigen (HBsAg), hepatitis C virus antibody, treponemal pallidum antibody, or human immunodeficiency virus (HIV) antibody; for patients with HBsAg-negative but hepatitis B core antibody (HBcAb)-positive, regardless of the status of hepatitis B surface antibody (HBsAb), HBV-DNA testing is required to confirm their condition, with HBV-DNA-positive patients excluded and HBV-DNA-negative patients eligible to participate in the study.\n5. General situation:\n\n   1. Pregnant or lactating females;\n   2. A history of alcohol abuse or illicit drug abuse within 1 year prior to screening;\n   3. A history of allergic diathesis, or known hypersensitivity\u002Fintolerance to any component of the investigational product;\n   4. Major surgery within 3 months prior to the screening, or planned major surgery during the study;\n   5. Any condition that, in the investigator's judgment, may affect evaluation of study drug safety and efficacy, or any other condition that renders the subject ineligible.","18 Years","75 Years",{"count":51,"type":21},60,[24],"This study is a multicenter, randomized, double-blind, placebo-controlled Phase II clinical trial designed to evaluate the efficacy, safety, pharmacokinetics, and pharmacodynamics of SHR-2173 compared to placebo as an add-on therapy to standard of care (SOC) for the treatment of generalized myasthenia gravis (gMG). The study consists of a 4-week screening period, a 24-week treatment period, and a 12-week safety follow-up period.",[55],"Generalized Myasthenia Gravis","2026-05-27",{"date":58,"type":32},"2026-06-03",{"date":34,"type":21},{"date":61,"type":21},"2027-12",{"name":38,"class":39},2,{"id":65,"slug":66,"hasResults":11,"nctId":67,"briefTitle":68,"officialTitle":69,"acronym":4,"eligibilityCriteria":70,"healthyVolunteers":11,"sex":16,"minAge":48,"maxAge":4,"enrollmentInfo":71,"targetDuration":4,"studyType":22,"phases":73,"briefSummary":75,"conditions":76,"keywords":4,"overallStatus":78,"whyStopped":4,"lastUpdateSubmitDate":79,"lastUpdatePostDateStruct":80,"startDateStruct":82,"completionDateStruct":84,"leadSponsor":85,"locationsCount":40},"100608838","phase-1-phase-i-study-of-shr-2173-injection-in-patients-with-primary-immune-thrombocytopenia-100608838","NCT07206758","Phase I Study of SHR-2173 Injection in Patients With Primary Immune Thrombocytopenia","A Phase I Study Evaluating the Safety, Efficacy, Pharmacokinetics and Pharmacokinetics of SHR-2173 Injection in Patients With Primary Immune Thrombocytopenia","Inclusion Criteria:\n\n1. Participants must fully understand the trial content, procedures, and potential adverse reactions, and voluntarily sign a written informed consent form (ICF).\n2. Age at signing the ICF must be ≥ 18 years (including the boundary value), regardless of gender.\n3. Confirmed diagnosis of primary ITP for at least 3 months at screening.\n4. Previous treatment with corticosteroids.\n5. At the last ITP treatment, participants experienced loss of remission, no remission, relapse after remission, or intolerance.\n6. Platelet count \\\u003C30×10⁹\u002FL at screening with clinical assessment indicating treatment necessity\n7. Participants must have adequate organ function\n8. Clinically stable condition with World Health Organization (WHO) bleeding scale grade 0-1\n9. Female participants of childbearing potential or male participants with fertile partners must refrain from sperm\u002Fova donation from ICF signing until 12 weeks after last dose and agree to protocol-specified contraceptive measures\n\nExclusion Criteria:\n\n1. Diagnosis of secondary thrombocytopenia or concomitant autoimmune hemolytic anemia\n2. Received platelet transfusion, whole blood transfusion, plasma exchange, or any other emergency treatment drugs within 14 days prior to the first infusion of SHR-2173\n3. Received immunosuppressants (other than corticosteroids) such as Janus kinase \\[JAK\\] inhibitors or Bruton tyrosine kinase \\[BTK\\] inhibitors within either 5 times the drug elimination half-life or 14 days prior to the first infusion of SHR-2173 (whichever is longer)\n4. Previous treatment with SHR-2173\n5. Screening prothrombin time or activated partial thromboplastin time outside the normal range; concurrent coagulation disorders and\u002For receiving antiplatelet or anticoagulant medications (e.g., warfarin, clopidogrel, novel oral anticoagulants), except for low-dose acetylsalicylic acid\n6. History of any thrombotic or embolic events within 12 months prior to the first administration, or clinical symptoms and history suggesting thrombophilia\n7. Current life-threatening bleeding (related to thrombocytopenia) or expected to require emergency treatment within one week after randomization\n8. Active viral, bacterial, or other infections (including tuberculosis \\[TB\\]) requiring systemic treatment at screening, or SARS-CoV-2 infection during screening, or history of clinically significant recurrent infections\n9. Received live or attenuated live vaccines within 8 weeks prior to the first administration of SHR-2173, or planned to receive live\u002Fattenuated vaccinations during the trial\n10. Received live or attenuated live vaccines within 8 weeks prior to the first administration of SHR-2173, or planned to receive live\u002Fattenuated vaccinations during the trial\n11. Diagnosis of myelodysplastic syndrome; history of or current malignancy within 5 years prior to screening (except for cured non-melanoma skin cancer, in situ carcinoma \\[e.g., cervical, breast, bladder, prostate cancer\\], and cancers in complete remission for at least 5 years with no evidence of recurrence)\n12. Previous splenectomy\n13. Previous allogeneic stem cell or organ transplantation (except for corneal transplantation ≥ 3 months prior to screening); known or suspected history of immunosuppression\n14. Planned surgery during the dosing period\n15. Any severe and\u002For unstable pre-existing medical, psychiatric, or other conditions that the investigator judges may interfere with patient safety, obtaining informed consent, or compliance with study procedures\n16. Allergic constitution (e.g., allergies to two or more drugs, foods, or pollens) or known hypersensitivity (immediate or delayed) or atopic reactions to the study drug (including excipients, monoclonal antibodies)\n17. Concurrent participation in other investigational studies within either 30 days prior to enrollment or 5 half-lives of the investigational drug (whichever is longer)\n18. Females who are lactating or pregnant (positive serum or urine β-human chorionic gonadotropin \\[hCG\\]) at screening or on Day 1 of Week 1 prior to administration",{"count":72,"type":21},10,[74],"PHASE1","Evaluate the safety and tolerance of multiple subcutaneous injections of SHR-2173 in ITP patients",[77],"Immune Thrombocytopenia","RECRUITING","2026-05-26",{"date":81,"type":32},"2026-05-28",{"date":83,"type":32},"2025-11-12",{"date":36,"type":21},{"name":38,"class":39},{"id":87,"slug":88,"hasResults":11,"nctId":89,"briefTitle":90,"officialTitle":91,"acronym":4,"eligibilityCriteria":92,"healthyVolunteers":11,"sex":16,"minAge":48,"maxAge":4,"enrollmentInfo":93,"targetDuration":4,"studyType":22,"phases":95,"briefSummary":96,"conditions":97,"keywords":4,"overallStatus":78,"whyStopped":4,"lastUpdateSubmitDate":99,"lastUpdatePostDateStruct":100,"startDateStruct":102,"completionDateStruct":104,"leadSponsor":105,"locationsCount":63},"100620231","phase-2-a-study-of-shr-2173-in-participants-with-primary-iga-nephropathy-100620231","NCT07354932","A Study of SHR-2173 in Participants With Primary IgA Nephropathy","A Randomized, Double-Blind, Placebo-Controlled Phase II Clinical Study to Evaluate the Efficacy and Safety of SHR-2173 Injection in Patients With Primary IgA Nephropathy","Inclusion Criteria:\n\n1. Male and female participants aged 18 or older\n2. Body weight ≥35 kg, BMI\\\u003C37.5 kg\u002Fm2\n3. At screening, 24-hour urinary protein quantification ≥1 g\u002F day, or 24-hour UPCR≥0.7 g\u002Fg\n4. eGFR≥30 mL\u002F minute \u002F1.73 m2 at screening\n5. Female subjects with fertility or male participants whose partners are women of childbearing age must avoid donating sperm\u002Feggs from the date of signing the ICF until 12 weeks after the last study medication, and agree to take contraceptive measures as specified in the protocol\n\nExclusion Criteria:\n\n\\-\n\n1、Presence of any of the following medical histories or comorbidities:\n\n1. Renal pathology consistent with IgAN, but secondary factors could not be excluded by investigator evaluation, including but not limited to: secondary to systemic diseases, infections, autoimmune diseases or tumors;\n2. A history of organ transplantation;\n3. A history of splenectomy;\n4. Presence or history of malignancy within 5 years before screening (note: skin squamous cell carcinoma, basal cell carcinoma or cervical carcinoma in situ with complete resection and no evidence of recurrence are excluded);\n5. A history of anaphylaxis such as generalized urticaria, angioedema, or anaphylaxis, or a known history of allergy to the study drug or any component of the study drug\n\n2、Use of any of the following drugs\u002Ftreatments or participation in a clinical study:\n\n1. Received systemic glucocorticoid therapy (including gut-targeted budesonide, etc.) within 12 weeks before randomization (Note: except those not used within 4 weeks before randomization and received prednisone ≤0.5mg\u002Fkg or equivalent glucocorticoid for non-IgAN disease within 52 weeks before randomization, with no more than 3 courses (each course ≤2 weeks);\n2. Receivied immunosuppressive therapy within 12 weeks before randomization;\n3. Received any investigational drug within 4 weeks before randomization or within the 5 half-lives of the trial drug, whichever was longer;\n4. Received a live \u002F attenuated live vaccine administered within 4 weeks before randomization\n\n3、History and examination related to infection:\n\n1. A history of infection (viral, bacterial, fungal, parasitic infection) within 3 months prior to screening, resulting in hospitalization and\u002For parenteral systemic antimicrobial therapy; Or a history of infection requiring systemic antimicrobial therapy within 14 days before randomization;\n2. Tuberculosis (TB) or occult TB infection (one of the following conditions) :\n\n   1. Presence of active TB or clinical symptoms of active TB at screening;\n   2. Signs of active TB on imaging examination within 3 months before screening\n\n      4、 General situation:\n\n1\\) Pregnant or lactating women; 2) Investigators determine that there are circumstances that affect the safety and efficacy evaluation of the investigational drug, or other circumstances not appropriate for participation in this study.",{"count":94,"type":21},84,[24],"This study is a randomized, double-blind, placebo-controlled Phase II clinical trial to evaluate the efficacy and safety of SHR-2173 in patients with Primary IgA Nephropathy(IgAN). The study consists of a screening period, a run-in period, a 48-week double-blind treatment period, and a 12-week follow-up period. Approximately 84 IgAN patients will be included.",[98],"Primary IgA Nephropathy","2026-05-11",{"date":101,"type":32},"2026-05-13",{"date":103,"type":32},"2026-03-09",{"date":61,"type":21},{"name":38,"class":39},{"id":107,"slug":108,"hasResults":11,"nctId":109,"briefTitle":110,"officialTitle":111,"acronym":4,"eligibilityCriteria":112,"healthyVolunteers":11,"sex":16,"minAge":48,"maxAge":113,"enrollmentInfo":114,"targetDuration":4,"studyType":22,"phases":116,"briefSummary":117,"conditions":118,"keywords":4,"overallStatus":78,"whyStopped":4,"lastUpdateSubmitDate":120,"lastUpdatePostDateStruct":121,"startDateStruct":122,"completionDateStruct":124,"leadSponsor":126,"locationsCount":63},"100615962","phase-2-a-study-of-shr-2173-in-participants-with-systemic-lupus-erythematosus-100615962","NCT07299422","A Study of SHR-2173 in Participants With Systemic Lupus Erythematosus","A Multi-center, Randomized, Double-blind, Placebo-controlled Phase II Clinical Study to Evaluate the Efficacy and Safety of SHR-2173 Injection in Patients With Systemic Lupus Erythematosus","Inclusion Criteria:\n\n1. Male and female participants aged 18 through 65 years (including boundary value)at the time of screening.\n2. The Body Mass Index (BMI) ≥18 kg\u002Fm ² at the time of screening.\n3. Diagnosed with SLE for at least 6 months prior to screening.\n4. ANA≥1:80, or anti-dsDNA antibodies and\u002For anti-Sm antibodies above the upper limit of the normal range as determined by a central laboratory at the time of screening.\n5. High disease activity at screening and at baseline.\n6. Currently receiving at least one or more of the following standard therapies for SLE at stable doses: oral corticosteroids (OCS), antimalarial drugs, and conventional immunosuppressants.\n7. Participants thoroughly understand the content, process and possible adverse reactions before the trial, and voluntarily sign the written informed Consent Form (ICF).\n8. Female subjects with fertility or male participants whose partners are women of childbearing age must avoid donating sperm\u002Feggs from the date of signing the ICF until 12 weeks after the last study medication, and agree to take contraceptive measures as specified in the protocol.\n\nExclusion Criteria:\n\n1. The presence of any of the following medical histories or comorbidities: a) Severe lupus-related kidney disease and\u002For kidney damage; b) Active neuropsychiatric SLE occurred 6 months prior to screening; c) Autoimmune, inflammatory or joint diseases other than SLE and LN that may interfere with the interpretation of the test results or clinical assessment, including but not limited to rheumatoid arthritis, overlap syndrome, psoriasis\u002Fpsoriatic arthritis, eczema, inflammatory bowel disease, and any other vasculitis; d) There was catastrophic or severe antiphospholipid syndrome within 12 months prior to screening; e) Have a history of progressive multifocal leukoencephalopathy (PML); f) Have a history of organ transplantation.\n2. Use any of the following medications \u002Ftreatments or participate in a clinical trial: a) Previously received gene therapy such as CAR-T or T-cell Engager (TCE) ; b) Received anti-CD20 monoclonal antibody within 6 months and other B-cell or plasma cell depletion treatments within 6 to 12 months prior to randomization; c) Received biologic therapy targeting BAFF, APRIL or interferon receptor within 12 weeks prior to randomization; d) Received Alkylating agents within 12 weeks prior to randomization; e) Received any other biological agents for the treatment of SLE within 12 weeks prior to randomization; f) Received inhibitors of Janus kinase (JAK), Bruton tyrosine kinase (BTK), or tyrosine kinase 2 (TYK2) within 12 weeks prior to randomization; g) Received intra-articular, intramuscular or intravenous corticosteroid for SLE within 4 weeks prior to randomization; h) Received a live\u002Fattenuated live vaccine within 4 weeks prior to randomization or planned to receive it during the trial period.\n3. The presence of the following tumor risks or accompanied by other poorly controlled serious or chronic diseases: a) Suffering from malignant tumors or having a history of malignant tumors; b) Accompanying other poorly controlled serious or chronic diseases during or at the time of screening, including but not limited to endocrine diseases, cardiovascular diseases, neurological\u002Fmental disorders, kidney diseases, severe digestive system diseases, severe respiratory system diseases, neurological diseases, and other serious liver, gallbladder, metabolic or lymphatic system diseases, etc.\n4. Infection-related medical history and examinations: a) Herpes zoster infection meets one of the following conditions: 1) A history of systemic herpes zoster, such as disseminated herpes zoster, herpetic encephalitis or ocular herpes zoster involving the retina; 2) Recurrent herpes zoster that has occurred twice or more within two years; 3) The herpes zoster infection has not completely subsided within 12 weeks before screening; b) Tuberculosis (TB) or occult tuberculosis infection; c) A history of primary immunodeficiency, splenectomy, and any potential conditions that make participants susceptible to infection; d) A history of repeated infections requiring hospitalization and intravenous antibiotics; e) Hospitalization and\u002For intravenous anti-infective treatment were required within 8 weeks prior to randomization, or any infection that required oral anti-infective treatment within 2 weeks prior to randomization; f) Positive test results for any of the following: hepatitis B surface antigen (HBsAg), hepatitis C virus antibody, Treponema pallidum antibody or human immunodeficiency virus (HIV); If the test result is negative for HBsAg but positive for hepatitis B core antibody (HBcAb), regardless of whether the hepatitis B surface antibody (HBsAb) is positive or negative, HBV-DNA testing is required to determine the situation: if HBV-DNA is positive, participants should be excluded. Participants can be included if HBV-DNA is negative.\n5. General situation: a) Pregnant or lactating women; b) Having a history of alcohol abuse or illegal drug abuse within one year prior to screening; c) Individuals with allergic constitutions, or those known to be intolerant or allergic to any component of the investigational drug; d) Participants who have undergone major surgeries within the 3 months prior to screening, or those who plan to undergo major surgeries during the trial period; e) Investigators determine that there are circumstances that affect the safety and efficacy evaluation of the investigational drug, or other circumstances not appropriate for participation in this study.","65 Years",{"count":115,"type":21},248,[24],"This study is a randomized, double-blind, multi-center, placebo-controlled Phase II clinical trial to evaluate the efficacy and safety of SHR-2173 in adult participants with active Systemic Lupus Erythematosus (SLE), including a 4-week screening period, a 24-week core treatment period, a 24-week maintenance treatment period, and a 12-week safety follow-up period. Approximately 245 SLE patients will be included.",[119],"Systemic Lupus Erythematosus","2026-05-08",{"date":99,"type":32},{"date":123,"type":32},"2026-04-03",{"date":125,"type":21},"2028-11",{"name":38,"class":39},{"id":128,"slug":129,"hasResults":11,"nctId":130,"briefTitle":131,"officialTitle":131,"acronym":4,"eligibilityCriteria":132,"healthyVolunteers":133,"sex":16,"minAge":48,"maxAge":49,"enrollmentInfo":134,"targetDuration":4,"studyType":22,"phases":136,"briefSummary":137,"conditions":138,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":139,"lastUpdatePostDateStruct":140,"startDateStruct":142,"completionDateStruct":143,"leadSponsor":145,"locationsCount":40},"100636606","phase-1-a-phase-i-study-to-evaluate-safety-tolerability-pharmacokinetics-and-pharmacodynamics-of-hrs-9821-powder-for-inhalation-administered-as-a-single-dose-in-healthy-participants-and-multiple-doses-in-patients-with-copd-100636606","NCT07567872","A Phase I Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of HRS-9821 Powder for Inhalation Administered as a Single Dose in Healthy Participants and Multiple Doses in Patients With COPD","Inclusion Criteria:\n\n1. Informed consent was obtained to participate in the trial\n2. Body weight ≥45 kg,and BMI 18-33 kg\u002Fm2 (both ends included)\n3. The 12-lead ECG was normal or abnormal but clinically insignificant until randomization\n4. Contraception was strict from the time informed consent was signed until 1 month (for subjects receiving HRS-9821\u002F placebo) or 3 months (for male subjects receiving moxifloxacin) after the last dose\n5. All study regulations and procedures were followed and inhalation devices used in the study were used correctly during the study\n\n   The following inclusion criteria apply only to healthy subjects:\n6. Vital signs were normal at screening\n7. Pulmonary function was normal during screening\n8. No smoking or smoking cessation ≥12 months before screening, and previous smoking history \\\u003C5 pack-years；\n9. Healthy male 18-50 years old\n\n   The following inclusion criteria apply only to subjects with COPD\n10. Male or female, aged 40-75 years;\n11. Patients diagnosed with COPD;\n12. A post-bronchodilator FEV1 \u002FFVC \\\u003C 0.7,40% ≤FEV1 \\\u003C 80% of the predicted value,;\n13. Smoking history of≥ 10 pack-years;\n14. Normal chest X-ray examination results at screening;\n15. Supporting discontinuation of COPD-related medications before randomization；\n\nExclusion Criteria:\n\n1. Mean QTcF ≥ 450 ms at screening；\n2. Persons who had donated blood or had massive blood loss (\\> 400 ml) within 4 weeks before screening or who were interested in donating blood during the study\n3. Receipt of the investigational drug or device within 4 weeks before randomization or less than 5 times the half-life of the drug, whichever was greater;\n4. Patients who had difficulty in blood collection or could not tolerate venipuncture in the past, such as dizzy with needles or blood\n5. History of malignancy in any organ system\n6. Known allergies to salbutamol, study medication, or any excipients in the formulation\n7. Known previous infection with human immunodeficiency virus (HIV), hepatitis B virus (HBV) or hepatitis C virus (HCV); Or positive HIV (according to a trial-site SOP), treponema pallidum antibody, HBV surface antigen, or HCV antibody before randomization\n8. History of alcohol abuse\n9. History of drug abuse and drug dependence in the past 5 years；\n10. Positive for alcohol or substance abuse test before randomization\n11. During the study, surgery or treatment that might interfere with the conduct of the study was planned；\n12. Unable or unwilling to fully adhere to the study protocol\n13. Mentally or legally incapacitated\n14. There were any other reasons for the subject not to participate in the study in the opinion of the investigator;\n15. Use of a strong\u002Fmoderate potency drug that inhibits or induces the hepatic drug-metabolizing enzyme CYP3A4 14 days before the first dose;\n16. Drugs with effects on P-glycoprotein (P-gp) or breast cancer resistance protein (BCRP) were anticipated to be used during the study;\n17. History of using HRS-9821 suspension;\n\n    The following exclusion criteria apply only to healthy subjects:\n18. Have been treated with antibiotics for upper and lower respiratory tract infections within 12 weeks prior to screening;\n19. Abnormal laboratory or physical examination results with clinical significance;\n20. Positive urine nicotine test before randomization;\n21. Have consumed a prescription within 14 days prior to the first dose or over-the-counter drugs within 48 h prior to the first dose;\n\nThe following exclusion criteria apply only to subjects with COPD 22. History of life-threatening acute exacerbation of COPD (AECOPD), including admission to intensive care unit and\u002For need for invasive ventilator support; 23. Diagnosed with other respiratory disorders; 24. Pulmonary heart disease, or pulmonary hypertension caused by lung disease and\u002For hypoxia; 25. History of lung volume reduction surgery, partial lung resection, lung transplantation, and other surgeries that may affect pulmonary function results; 26. History of AECOPD requiring systemic glucocorticoids or antibiotics or hospitalization within 4 weeks prior to screening; 27. Lower respiratory tract infection requiring antibiotic treatment within 4 weeks prior to screening; 28. Requiring oxygen therapy or home non-invasive ventilation; 29. Currently using or plan to use non-selective beta blockers or other drugs with bronchoconstrictive effects during the study; 30. Patients with serious trauma or major surgery within 6 months prior to screening who are still in the recovery period; 31. Abnormal laboratory tests at screening and baseline.",true,{"count":135,"type":21},48,[74],"The aim of this study was to evaluate the safety and tolerability of HRS-9821 Powder for Inhalation administered in a single dose in healthy individuals and multiple doses in patients with COPD。",[27],"2026-04-28",{"date":141,"type":32},"2026-05-05",{"date":34,"type":21},{"date":144,"type":21},"2026-09",{"name":38,"class":39},{"id":147,"slug":148,"hasResults":11,"nctId":149,"briefTitle":150,"officialTitle":150,"acronym":4,"eligibilityCriteria":151,"healthyVolunteers":133,"sex":16,"minAge":48,"maxAge":152,"enrollmentInfo":153,"targetDuration":4,"studyType":22,"phases":155,"briefSummary":156,"conditions":157,"keywords":4,"overallStatus":78,"whyStopped":4,"lastUpdateSubmitDate":159,"lastUpdatePostDateStruct":160,"startDateStruct":162,"completionDateStruct":164,"leadSponsor":166,"locationsCount":40},"100610602","phase-1-study-on-the-drug-interactions-of-hrs-9813-pirfenidone-and-nintedanib-in-healthy-subjects-100610602","NCT07229716","Study on the Drug Interactions of HRS-9813, Pirfenidone and Nintedanib in Healthy Subjects","Inclusion Criteria:\n\n1. Voluntarily sign the informed consent form before the start of the related activities of this trial, and be able to understand the procedures and methods of this trial. Also, be willing to strictly follow the clinical trial protocol to complete this trial.\n2. Aged 18-45 years.\n3. Male weight ≥ 50 kg, female weight ≥ 45 kg, and body mass index (BMI): 19 - 28 kg\u002Fm2 (including both endpoints).\n4. Sign the informed consent form and, within 28 days after the last administration of the trial drug, have no intention of having children and agree to adopt non-drug methods of effective contraception, and have no plans for sperm donation or egg donation.\n\nExclusion Criteria:\n\n1. Those who are allergic to the study drugs (HRS-9813 capsules, nintedanib or pirfenidone), or any components of the study drugs, or have an allergic constitution (such as individuals with asthma, allergic rhinitis, or eczema).\n2. Those subjects who, in the judgment of the researchers, have any conditions or diseases that may affect the absorption, metabolism, and\u002For excretion of the study drug.\n3. Those who participated in any clinical trial of other drugs or medical devices within the previous 3 months before the screening period or baseline period, or those whose exposure to the drug is still within 5 half-lives during the study period (whichever is longer).\n4. During the screening period or baseline period, the sitting systolic blood pressure was less than 90 mmHg or the sitting diastolic blood pressure was less than 60 mmHg.\n5. During the screening period, any one of the following being positive: hepatitis B surface antigen (HBsAg), human immunodeficiency virus antibody, Treponema pallidum antibody or hepatitis C virus antibody.\n6. Pregnant or lactating women, or those whose blood pregnancy test results in the screening or baseline phase are positive.\n7. Those who have a history of blood donation within 8 weeks before the screening period or the baseline period, or have suffered from severe blood loss (blood loss ≥ 400 mL), or have received blood transfusion within 4 weeks before the screening period or the baseline period; or those who plan to donate blood during the trial.\n8. Those who were vaccinated within the two weeks prior to the screening period or the baseline period, or those who plan to receive the vaccine during the trial process.\n9. Those who have special dietary requirements and cannot follow the uniform diet.\n10. Those who have difficulty swallowing, have problems with venous blood collection, or whose physical condition does not allow for intensive blood sampling.\n11. Those who have had severe infections, severe trauma or undergone heavy manual surgery within 3 months before the screening period or baseline period; Or those who plan to undergo surgery during the trial period.\n12. During the screening period or baseline period, for those with abnormal 12-lead electrocardiogram results and clinical significance, the QTcB of men was \\> 450ms and that of women was \\> 460 ms.\n13. Those who have a history of smoking (smoking more than 5 cigarettes per day on average) within 3 months before the screening period or baseline period, or those who have a smoking history within 4 weeks before the screening period or baseline period, or those who cannot stop using any tobacco products during the trial period.\n14. Those who have a history of drug use or drug abuse\u002Fdependence before the screening period or baseline period; Or those with positive urine test results during the baseline period.\n15. Those who consumed excessive amounts of tea, coffee or caffeinated beverages (an average of more than 8 cups per day, 250 mL per cup) within 6 months prior to the screening period or baseline period.","45 Years",{"count":154,"type":21},20,[74],"This study aims to evaluate the interaction of oral HRS-9813 capsules with pirfenidone and nintedanib on the pharmacokinetics of healthy subjects.",[158],"Pulmonary Fibrosis","2026-04-23",{"date":161,"type":32},"2026-04-27",{"date":163,"type":32},"2026-04-04",{"date":165,"type":21},"2026-05",{"name":38,"class":39},{"id":168,"slug":169,"hasResults":11,"nctId":170,"briefTitle":171,"officialTitle":172,"acronym":4,"eligibilityCriteria":173,"healthyVolunteers":11,"sex":16,"minAge":48,"maxAge":4,"enrollmentInfo":174,"targetDuration":4,"studyType":22,"phases":176,"briefSummary":178,"conditions":179,"keywords":4,"overallStatus":78,"whyStopped":4,"lastUpdateSubmitDate":159,"lastUpdatePostDateStruct":181,"startDateStruct":183,"completionDateStruct":185,"leadSponsor":187,"locationsCount":40},"100558698","phase-2-clinical-study-of-the-efficacy-and-safety-of-shr-1819-injection-in-adult-patients-with-prurigo-nodularis-100558698","NCT06554509","Clinical Study of the Efficacy and Safety of SHR-1819 Injection in Adult Patients With Prurigo Nodularis","A Multicenter, Randomized, Double-blind, Placebo-controlled Phase II\u002FIII Clinical Study of the Efficacy and Safety of SHR-1819 Injection in Adult Patients With Prurigo Nodularis","Inclusion Criteria:\n\n1. Subjects voluntarily sign informed consent forms prior to the commencement of any proceedings related to the study, are able to communicate smoothly with the investigator, understand and are willing to complete the study in strict compliance with the requirements of this clinical research protocol.\n2. The age was ≥18 at the time of signing the informed consent and gender is unlimited.\n3. Has prurigo nodularis at screening.\n\nExclusion Criteria:\n\n1. Pregnant or lactating women.\n2. Screening for people with a history of heavy alcohol consumption or substance abuse in the 6 months prior to screening.\n3. Has an active skin disease or skin complications due to other diseases that may affect the evaluation of PN.\n4. PN secondary to medical conditions such as neurological or psychiatric disorders.\n5. Diagnosis of moderate to severe AD during the screening\u002Flead-in period or prior to randomization.\n6. History of clinically significant diseases (e.g., circulatory system abnormalities, endocrine system abnormalities, neurological disorders, hematologic disorders, immune system disorders, psychiatric disorders, and metabolic instability) that the researcher believes that participation in the study poses a risk to the safety of the subject or that the disease\u002Fillness worsens during the study period will affect the effectiveness or safety analysis.\n7. Phase II: Treated with biologics targeting IL-4Rα, or participated in previous clinical studies of biologics targeting IL-4Rα, including SHR-1819 injection. Phase III: Subjects who have previously received anti-IL-4Rα biologics for any indication including atopic dermatitis (AD), asthma, sinusitis, etc., and were judged by the investigator to have an inadequate response or intolerance (e.g., experienced drug-related adverse reactions requiring treatment discontinuation) must be excluded even if the washout requirement is met.\n8. Subjects with malignancy prior to screening (except for squamous cell carcinoma of the skin, basal cell carcinoma, or carcinoma in situ of the cervix that are completely resected and have no evidence of recurrence).\n9. Major surgeries are planned for the duration of the study.\n10. Other conditions that, in the opinion of the investigator, are not suitable for participation in this study.",{"count":175,"type":21},423,[24,177],"PHASE3","This trial was designed to evaluate the efficacy and safety of SHR-1819 injection in patients with Prurigo Nodularis.",[180],"Prurigo Nodularis",{"date":182,"type":32},"2026-04-29",{"date":184,"type":32},"2024-09-19",{"date":186,"type":21},"2028-10",{"name":38,"class":39},{"id":189,"slug":190,"hasResults":11,"nctId":191,"briefTitle":192,"officialTitle":193,"acronym":4,"eligibilityCriteria":194,"healthyVolunteers":11,"sex":16,"minAge":48,"maxAge":49,"enrollmentInfo":195,"targetDuration":4,"studyType":22,"phases":197,"briefSummary":198,"conditions":199,"keywords":4,"overallStatus":78,"whyStopped":4,"lastUpdateSubmitDate":201,"lastUpdatePostDateStruct":202,"startDateStruct":204,"completionDateStruct":206,"leadSponsor":208,"locationsCount":40},"100609206","phase-2-a-study-to-investigate-the-efficacy-and-safety-of-shr-1905-in-patients-with-moderate-to-severe-atopic-dermatitis-100609206","NCT07211542","A Study to Investigate the Efficacy and Safety of SHR-1905 in Patients With Moderate-to-severe Atopic Dermatitis","A Randomized, Double-blind, Placebo-controlled Phase IIa Study to Evaluate the Efficacy and Safety of SHR-1905 Injection in Patients With Moderate to Severe Atopic Dermatitis","Inclusion Criteria:\n\n1. The subjects have voluntarily signed the informed consent form prior to the start of any procedures related to the study, are able to communicate smoothly with the researcher, understand and are willing to strictly abide by the requirements of this clinical research protocol to complete the study.\n2. At the time of signing the informed consent, the subjects are ≥ 18 years old and ≤ 75 years old, male or female.\n3. Have atopic dermatitis at screening.\n\nExclusion Criteria:\n\n1. Hypersensitivity to the study drug or any ingredient in the study drug.\n2. Have other active skin disease or skin complications due to other conditions that may affect the evaluation of Atopic Dermatitis (AD).\n3. Has malignancy or has a history of malignancy.\n4. Have serious concomitant diseases and other conditions that the investigator considers inappropriate to participate in this trial.\n5. Females who are pregnant or lactating.",{"count":196,"type":21},75,[24],"This trial was designed to evaluate the efficacy and safety of SHR-1905 in patients with moderate-to-severe atopic dermatitis.",[200],"Moderate-to-severe Atopic Dermatitis","2026-04-02",{"date":203,"type":32},"2026-04-08",{"date":205,"type":32},"2025-11-07",{"date":207,"type":21},"2027-02",{"name":38,"class":39},{"id":210,"slug":211,"hasResults":11,"nctId":212,"briefTitle":213,"officialTitle":214,"acronym":4,"eligibilityCriteria":215,"healthyVolunteers":11,"sex":16,"minAge":216,"maxAge":217,"enrollmentInfo":218,"targetDuration":4,"studyType":22,"phases":220,"briefSummary":221,"conditions":222,"keywords":4,"overallStatus":78,"whyStopped":4,"lastUpdateSubmitDate":224,"lastUpdatePostDateStruct":225,"startDateStruct":227,"completionDateStruct":229,"leadSponsor":230,"locationsCount":63},"100616703","phase-3-a-study-of-shr-1819-injection-in-adolescents-with-severe-atopic-dermatitis-100616703","NCT07309055","A Study of SHR-1819 Injection in Adolescents With Severe Atopic Dermatitis","A Multicenter, Randomized, Double-blind, Placebo-controlled Phase III Study Evaluating the Efficacy and Safety of SHR-1819 Injection in Adolescents With Severe Atopic Dermatitis","Inclusion Criteria:\n\n1. Male or female ≥12 to ≤17 years of age at time of screening visit, body weight ≥30kg;\n2. Diagnosis of Atopic Dermatitis (AD) at least 6 months prior to the screening visit according to the American Academy of Dermatology consensus criteria (Eichenfield 2014);\n3. Diagnosis of moderate to severe AD at the screening visit and baseline visits meet all of the following 3 criteria simultaneously: EASI ≥16, IGA ≥3, BSA≥10%;\n4. Baseline Pruritus Numerical Rating Scale (NRS) average score for maximum itch intensity ≥4 (A minimum of 5 daily scores out of the 7 days is required to calculate the baseline average score);\n5. With documented recent history (within 6 months before the screening visit) of inadequate response to topical AD medication(s) or for whom topical treatments is medically inadvisable (eg, intolerance, because of important side effects or safety risks). Patients with documented systemic treatment (systemic immunosuppressant drugs like cyclosporine, methotrexate, corticosteroids etc.) for AD in the past 6 months are also considered as inadequate responders to topical treatments;\n6. Has applied a stable dose of topical emollient (moisturizer) twice daily for at least the 7 consecutive days immediately before the baseline visit;\n7. Participants and their parents\u002Flegal guardians voluntarily sign the informed consent form prior to the initiation of any study-related procedures, are able to communicate smoothly with the investigators, and understand and agree to strictly comply with the requirements of this clinical study protocol to complete the study.\n\nExclusion Criteria:\n\n1. Has other active skin diseases (e.g., psoriasis or systemic lupus erythematosus) that may affect AD assessment, or skin complications caused by other diseases at screening visit;\n2. Has a history of vernal keratoconjunctivitis (VKC) and\u002For atopic keratoconjunctivitis (AKC) within 6 months prior to screening visit;\n3. Has received any of the following medications within 1 week prior to randomization: a) Topical corticosteroids (TCS) or topical calcineurin inhibitors (TCI); b) Topical traditional Chinese medicine (TCM) for atopic dermatitis; c) Other topical medications with therapeutic effects on AD (including but not limited to topical phosphodiesterase-4 \\[PDE-4\\] inhibitors, topical JAK inhibitors, etc.); d) Emollients containing active ingredients (e.g., ceramide, hyaluronic acid, urea, or filaggrin breakdown products); e) Leukotriene inhibitors (Note: If the participant is not taking such medications orally at randomization, they must have been off oral administration for at least 1 week prior to randomization; if the participant is taking such medications orally at randomization, they must have received stable-dose treatment for ≥2 weeks prior to randomization and continue stable use throughout the study period);\n4. Has received ≥2 bleach baths within 2 weeks prior to randomization;\n5. Has received any of the following treatments within 4 weeks prior to randomization: a) systemic glucocorticoids, immunosuppressants (including but not limited to cyclosporine, azathioprine, methotrexate, etc.), or JAK inhibitors; b) Systemic traditional Chinese medicine (TCM) for atopic dermatitis (including but not limited to Tripterygium Glycosides Tablets, Compound Glycyrrhizin Tablets, etc.); c) Phototherapy (including but not limited to narrowband ultraviolet B \\[NB-UVB\\] and ultraviolet A1 \\[UVA1\\]) or regular use of tanning booths\u002Froom;\n6. Has received investigational drugs or medical devices within 8 weeks prior to randomization or within 5 half-lives (if the half-life is known), whichever is longer;\n7. Has used biological products (including but not limited to anti-IL-4Rα monoclonal antibodies, anti-IgE monoclonal antibodies, anti-TSLP monoclonal antibodies, etc.) within 10 weeks prior to randomization or within 5 half-lives (if the half-life is known), whichever is longer;\n8. Has received or been exposed to other live vaccines or attenuated live vaccines within 3 months prior to randomization, or participated in a vaccine clinical trial within 3 months prior to the first dose;\n9. Has received any cell-depleting agents (including but not limited to rituximab) within 6 months prior to randomization;\n10. Has received allergen-specific immunotherapy within 6 months prior to randomization;\n11. Has a current malignant tumor or history of malignant tumor at screening;\n12. Has undergone major surgery within 3 months prior to the first dose before randomization, or plans to undergo major surgery during the study period;\n13. Has severe comorbid diseases or other conditions deemed inappropriate for participation in the study by the investigator, including but not limited to endocrine diseases;\n14. Has been diagnosed with or deemed by the investigator to have suspected immunosuppressive diseases within 6 months prior to screening, including but not limited to non-tuberculous mycobacterial infection, history of opportunistic infections;\n15. Has a history of infection treated with systemic antimicrobials (for viral, bacterial, fungal, or parasitic infections) within 2 weeks prior to randomization, or has superficial skin infections (e.g., impetigo);\n16. Has a history of recurrent herpes zoster or Kaposi varicelliform eruption (≥ 2 episodes), disseminated herpes zoster, or disseminated herpes simplex within 1 year prior to screening;\n17. Suspected or confirmed active tuberculosis (TB);\n18. Positive results for human immunodeficiency virus (HIV) antibody, syphilis antibody, or hepatitis C virus (HCV) antibody;\n19. Presence of any of the following abnormalities in laboratory tests (including but not limited to HGB\\\\WBC\\\\Neutrophil\\\\ALT\\\\AST\\\\T-BIL\\\\eGFR) and\u002For 12-lead electrocardiogram (ECG) within 4 weeks prior to randomization;\n20. Known hypersensitivity to the study drug or any of its components.","12 Years","17 Years",{"count":219,"type":21},201,[177],"This trial was designed to evaluate the efficacy and safety of SHR-1819 in adolescents with moderate-to-severe atopic dermatitis.",[223],"Adolescents With Moderate-to-severe Atopic Dermatitis","2026-04-01",{"date":226,"type":32},"2026-04-07",{"date":228,"type":32},"2026-03-21",{"date":61,"type":21},{"name":38,"class":39},{"id":232,"slug":233,"hasResults":11,"nctId":234,"briefTitle":235,"officialTitle":236,"acronym":4,"eligibilityCriteria":237,"healthyVolunteers":11,"sex":16,"minAge":48,"maxAge":4,"enrollmentInfo":238,"targetDuration":4,"studyType":22,"phases":239,"briefSummary":240,"conditions":241,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":243,"lastUpdatePostDateStruct":244,"startDateStruct":246,"completionDateStruct":248,"leadSponsor":250,"locationsCount":40},"100627134","phase-2-a-study-to-evaluate-shr-1139-injection-in-patients-with-pyoderma-gangrenosum-100627134","NCT07444684","A Study to Evaluate SHR-1139 Injection in Patients With Pyoderma Gangrenosum","A Phase II Clinical Study to Evaluate the Efficacy, Safety and Pharmacokinetics of SHR-1139 Injection in Adult Patients With Pyoderma Gangrenosum","Inclusion Criteria:\n\n1. Aged ≥18 years at the time of signing the informed consent form, regardless of gender;\n2. Confirmed as having ulcerative pyoderma gangrenosum (PG) with a PARACELSUS score of ≥10 points at screening;\n3. At screening and baseline, having at least one measurable PG ulcer (defined as an ulcer with a measured area of ≥ 5 cm²);\n4. The participant voluntarily signs the informed consent form before the initiation of any study-related procedures, is able to communicate smoothly with the investigator, and understands and is willing to strictly comply with the requirements of this clinical study protocol to complete the study;\n5. Female participants of childbearing potential or male participants whose female partners are of childbearing potential have no plans for childbirth, sperm\u002Fegg donation from the time of signing the informed consent form, and voluntarily adopt highly effective contraceptive measures (including by the partner). Female participants must have a negative pregnancy test result during the screening period and before randomization and dosing, and must not be breastfeeding.\n\nExclusion Criteria:\n\n1. Non-pyoderma gangrenosum (PG) diseases presenting with other ulcers or other similar skin lesions at screening;\n2. The measured area of the target PG ulcer exceeding 80 cm² at screening;\n3. Participants with chronic, non-inflammatory PG wounds or ulcers judged by the investigator to be unresponsive to immunosuppressive therapy at screening;\n4. Participants with active infection in the PG ulcer(s) at screening;\n5. A history of lymphoproliferative disorders, including lymphoma or signs and symptoms of potential lymphoproliferative diseases;\n6. A history of any active malignant tumor or malignant neoplasm within 5 years prior to the screening visit, except for curatively treated cutaneous squamous cell carcinoma, basal cell carcinoma, or carcinoma in situ of the uterine cervix;\n7. Any condition judged by the investigator to interfere with the assessment of the study drug's safety and efficacy.",{"count":154,"type":21},[24],"This study aims to evaluate the efficacy, safety, pharmacokinetics (PK) and immunogenicity of SHR-1139 Injection in patients with pyoderma gangrenosum.",[242],"Pyoderma Gangrenosum","2026-02-26",{"date":245,"type":32},"2026-03-03",{"date":247,"type":21},"2026-03-05",{"date":249,"type":21},"2028-04",{"name":38,"class":39},{"id":252,"slug":253,"hasResults":11,"nctId":254,"briefTitle":255,"officialTitle":255,"acronym":4,"eligibilityCriteria":256,"healthyVolunteers":133,"sex":16,"minAge":48,"maxAge":49,"enrollmentInfo":257,"targetDuration":4,"studyType":22,"phases":259,"briefSummary":260,"conditions":261,"keywords":4,"overallStatus":78,"whyStopped":4,"lastUpdateSubmitDate":262,"lastUpdatePostDateStruct":263,"startDateStruct":265,"completionDateStruct":267,"leadSponsor":269,"locationsCount":40},"100601931","phase-1-a-phase-i-study-of-the-safety-tolerability-pharmacokinetics-and-pharmacodynamics-for-a-single-dose-of-hrs-9821-powder-for-inhalation-and-inhalation-suspension-administered-in-healthy-subjects-and-multiple-doses-in-patients-with-copd-100601931","NCT07116915","A Phase I Study of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics for a Single Dose of HRS-9821 Powder for Inhalation and Inhalation Suspension Administered in Healthy Subjects and Multiple Doses in Patients With COPD.","Inclusion Criteria:\n\n1. Informed consent was obtained to participate in the trial\n2. Body weight ≥45 kg, BMI 18-33 kg\u002Fm2 (both ends included)\n3. The 12-lead ECG was normal or abnormal but clinically insignificant until randomization\n4. Contraception was strict from the time informed consent was signed until 1 month (for subjects receiving HRS-9821\u002F placebo) or 3 months (for male subjects receiving moxifloxacin) after the last dose\n5. All study regulations and procedures were followed and inhalation devices used in the study were used correctly during the study\n\n   The following inclusion criteria apply only to healthy subjects:\n6. Vital signs were normal at screening\n7. Pulmonary function was normal during screening\n8. No smoking or smoking cessation ≥12 months before screening, and previous smoking history \\\u003C5 pack-years；\n9. Healthy male 18-50 years old The following inclusion criteria apply only to subjects with COPD\n10. Male or female, aged 40-75 years;\n11. Patients diagnosed with COPD;\n12. A post-bronchodilator FEV1 \u002FFVC \\\u003C 0.7,40% ≤FEV1 \\\u003C 80% of the predicted value,;\n13. Smoking history of≥ 10 pack-years;\n14. Normal chest X-ray examination results at screening;\n15. Supporting discontinuation of COPD-related medications before randomization；\n\nExclusion Criteria:\n\n1. Mean QTcF ≥ 450 ms at screening；\n2. Persons who had donated blood or had massive blood loss (\\> 400 ml) within 4 weeks before screening or who were interested in donating blood during the study\n3. Receipt of the investigational drug or device within 4 weeks before randomization or less than 5 times the half-life of the drug, whichever was greater;\n4. Patients who had difficulty in blood collection or could not tolerate venipuncture in the past, such as dizzy with needles or blood\n5. History of malignancy in any organ system\n6. Known allergies to salbutamol, study medication, or any excipients in the formulation\n7. Known previous infection with human immunodeficiency virus (HIV), hepatitis B virus (HBV) or hepatitis C virus (HCV); Or positive HIV (according to a trial-site SOP), treponema pallidum antibody, HBV surface antigen, or HCV antibody before randomization\n8. History of alcohol abuse\n9. History of drug abuse and drug dependence in the past 5 years；\n10. Positive for alcohol or substance abuse test before randomization\n11. During the study, surgery or treatment that might interfere with the conduct of the study was planned；\n12. Unable or unwilling to fully adhere to the study protocol\n13. Mentally or legally incapacitated\n14. There were any other reasons for the subject not to participate in the study in the opinion of the investigator;\n15. Use of a strong\u002Fmoderate potency drug that inhibits or induces the hepatic drug-metabolizing enzyme CYP3A4 14 days before the first dose;\n16. Drugs with effects on P-glycoprotein (P-gp) or breast cancer resistance protein (BCRP) were anticipated to be used during the study;\n17. History of using HRS-9821 suspension;\n\n    The following exclusion criteria apply only to healthy subjects:\n18. Have been treated with antibiotics for upper and lower respiratory tract infections within 12 weeks prior to screening;\n19. Abnormal laboratory or physical examination results with clinical significance;\n20. Positive urine nicotine test before randomization;\n21. Have consumed a prescription within 14 days prior to the first dose or over-the-counter drugs within 48 h prior to the first dose; The following exclusion criteria apply only to subjects with COPD\n22. History of life-threatening acute exacerbation of COPD (AECOPD), including admission to intensive care unit and\u002For need for invasive ventilator support;\n23. Diagnosed with other respiratory disorders;\n24. Pulmonary heart disease, or pulmonary hypertension caused by lung disease and\u002For hypoxia;\n25. History of lung volume reduction surgery, partial lung resection, lung transplantation, and other surgeries that may affect pulmonary function results;\n26. History of AECOPD requiring systemic glucocorticoids or antibiotics or hospitalization within 4 weeks prior to screening;\n27. Lower respiratory tract infection requiring antibiotic treatment within 4 weeks prior to screening;\n28. Requiring oxygen therapy or home non-invasive ventilation;\n29. Currently using or plan to use non-selective beta blockers or other drugs with bronchoconstrictive effects during the study;\n30. Patients with serious trauma or major surgery within 6 months prior to screening who are still in the recovery period;\n31. Abnormal laboratory tests at screening and baseline.",{"count":258,"type":21},160,[74],"The aim of this study was to evaluate the safety and tolerability of HRS-9821 Powder for Inhalation and inhalation suspension administered in a single dose in healthy individuals and multiple doses in patients with COPD",[27],"2026-02-24",{"date":264,"type":32},"2026-02-27",{"date":266,"type":32},"2025-08-11",{"date":268,"type":21},"2026-12",{"name":38,"class":39},{"id":271,"slug":272,"hasResults":11,"nctId":273,"briefTitle":274,"officialTitle":274,"acronym":4,"eligibilityCriteria":275,"healthyVolunteers":11,"sex":16,"minAge":48,"maxAge":49,"enrollmentInfo":276,"targetDuration":4,"studyType":22,"phases":277,"briefSummary":278,"conditions":279,"keywords":4,"overallStatus":78,"whyStopped":4,"lastUpdateSubmitDate":281,"lastUpdatePostDateStruct":282,"startDateStruct":284,"completionDateStruct":286,"leadSponsor":288,"locationsCount":40},"100615219","phase-2-phase-ii-randomized-open-label-multicenter-clinical-study-evaluating-the-safety-efficacy-pharmacokinetics-and-pharmacodynamics-of-shr-2173-injection-in-patients-with-primary-membranous-nephropathy-100615219","NCT07289763","Phase II Randomized, Open-label, Multicenter Clinical Study Evaluating the Safety, Efficacy, Pharmacokinetics, and Pharmacodynamics of SHR-2173 Injection in Patients With Primary Membranous Nephropathy","Inclusion Criteria:\n\n1. Age 18-75 years, regardless of gender;\n2. Weight ≥40.0 kg at screening;\n3. Diagnosed as primary membranous nephropathy through kidney biopsy.\n\nExclusion Criteria:\n\n1. Secondary membranous nephropathy.\n2. Subjects developed rapidly progressive glomerulonephritis or required kidney transplantation.\n3. Subjects who have undergone kidney dialysis in the previous 12 months or are expected to require dialysis during the study period.\n4. Subjects who have a malignant tumor or a history of malignant tumor\n5. Subjects who have undergone major surgery within the previous 3 months, or plan to undergo major surgery during the study period.",{"count":196,"type":21},[24],"To investigate the safety, efficacy, pharmacokinetics, and pharmacodynamics of SHR-2173 injection in patients with primary membranous nephropathy",[280],"Primary Membranous Nephropathy","2026-01-22",{"date":283,"type":32},"2026-01-26",{"date":285,"type":32},"2025-12-31",{"date":287,"type":21},"2027-09",{"name":38,"class":39},{"id":290,"slug":291,"hasResults":11,"nctId":292,"briefTitle":293,"officialTitle":293,"acronym":4,"eligibilityCriteria":294,"healthyVolunteers":11,"sex":16,"minAge":295,"maxAge":4,"enrollmentInfo":296,"targetDuration":4,"studyType":22,"phases":298,"briefSummary":299,"conditions":300,"keywords":4,"overallStatus":78,"whyStopped":4,"lastUpdateSubmitDate":302,"lastUpdatePostDateStruct":303,"startDateStruct":305,"completionDateStruct":307,"leadSponsor":309,"locationsCount":40},"100607775","phase-2-multicenter-randomized-double-blind-placebo-controlled-phase-ii-trial-to-evaluate-the-efficacy-and-safety-of-hrs-9813-in-subjects-with-pulmonary-fibrosis-100607775","NCT07192939","Multicenter, Randomized, Double-blind, Placebo-controlled Phase II Trial to Evaluate the Efficacy and Safety of HRS-9813 in Subjects With Pulmonary Fibrosis","Inclusion Criteria:\n\n1. Informed consent was obtained to participate in the trial\n2. Patients were aged ≥21 years for PPF and ≥45 years for IPF.\n3. IPF diagnosed within 7 years before screening (including the screening period) or evidence of progressive ILD within 12 months before screening;\n4. HRCT and surgical lung biopsy or transbronchial lung cryobiopsy, when available, support the clinical diagnosis;\n5. The central HRCT reading results of PPF at screening showed that the whole lung parenchymal fibrosis was \\> 10%;\n6. Treatment with nintedanib or pirfenidone was discontinued at least 8 weeks before screening or was stabilized for at least 8 weeks;\n7. FVC as a percentage of normal predicted value ≥40%;\n8. DLCO SB (Hb corrected) as a percentage of normal predicted value ≥25%;\n9. Female subjects of childbearing potential must have a negative pregnancy test before the first dose of medication. And must be non-lactating. Female subjects of childbearing potential or male subjects whose partner is a female of childbearing potential agree to be infertile, have a sperm\u002Fegg donation plan, and voluntarily use highly effective contraception (including their partner) from the time they sign ICF until 14 days after the last dose of medication, which is the end of safety follow-up.\n\nExclusion Criteria:\n\n1. IPF cohort: i. Interstitial lung disease (ILD) of other known cause; ii. Diagnosis of sarcoidosis or any systemic autoimmune disease；\n2. PPF cohort: IPF diagnosis and UIP features supported by HRCT central reading, surgical lung biopsy, or cryobiopsy pathology.\n3. The presence of emphysema of 50% or more on centrally read HRCT or the degree of emphysema greater than the degree of fibrosis on the basis of the most recent HRCT report.\n4. The presence of clinically significant nonsubstantial lung disease was considered by the investigator to be likely to affect the assessment of the study.\n5. Subjects were known to have pulmonary hypertension requiring treatment with multiple medications.\n6. Active tuberculosis infection within 12 months before and\u002For during screening, or lower respiratory tract infection requiring antibiotic treatment within 4 weeks before and\u002For during screening, or evidence of active infection on clinical and laboratory tests at the screening\u002Fbaseline visit.\n7. Acute exacerbations of IPF\u002FILD occurred within 12 weeks before and\u002For during screening.\n8. A history of unstable or worsening cardiac disease within 6 months before screening\n9. Uncontrolled atrial or ventricular arrhythmias or the known presence of significant left ventricular dysfunction.\n10. A cerebrovascular event leading to hospitalization had occurred within 6 months before screening\n11. Had a history of lung volume reduction surgery or transplant, were awaiting lung transplant, or were scheduled to undergo lung volume reduction surgery or transplant during the study period.\n12. Subjects with a history of malignancy within the previous 5 years, or a suspicion of malignancy on biopsy, and those for whom the possibility of malignancy could not be reasonably ruled out after additional clinical, laboratory, or other diagnostic evaluation were screened.\n13. The patients were positive for hepatitis B surface antigen (HBsAg) or hepatitis C virus antibody (HCVAb) at the time of screening. A test for antibodies to the human immunodeficiency virus (HIV) was not negative at screening.\n14. A history of smoking (including e-cigarettes) within 3 months before screening or an unwillingness to quit smoking during the study.\n15. Regular alcohol consumption in the 6 months before screening or an unwillingness to reduce alcohol consumption to less than 21 units during the study.\n16. He had a history of substance abuse within 6 months before screening.\n17. Pregnant or breastfeeding.\n18. Treatment with prednisone at a dose of more than 15 mg per day or another systemic glucocorticoid at the equivalent dose was received within 4 weeks before screening and during the study.\n19. Use of an IL-6 inhibitor within 3 months before screening and planned use during the study.\n20. Disease-modifying antirheumatic drugs or a change in dose were initiated within 3 months before screening.\n21. Initiation of mycophenolate mofetil, mycophenolic acid, azathioprine, tacrolimus, methotrexate, leflunomide, or a change in the dose of the above drugs within 3 months before screening; Immunosuppressive drugs could not be started during the treatment phase.\n22. Rituximab was used 6 months before screening and was planned for the duration of the study.\n23. Participants who had used a potent inhibitor or inducer of cytochrome P450(CYP)3A4 within 4 weeks before randomization or who had to be treated with or planned to be treated with a drug ban during the study.\n24. Persons who had participated in a clinical trial of any drug or device within 1 month before screening and who had expected legacy effects of the trial treatment (at the discretion of the investigator) or who were within the follow-up period of a clinical study or the five half-lives of the trial drug before screening.\n25. Major surgery (surgery under general anesthesia) that was performed within 3 months before screening or that was planned during the study that, as assessed by the investigator, would affect the determination of the end points.\n26. Uncontrolled hypertension was present before screening or randomization.\n27. Patients with orthostatic intolerance, orthostatic hypotension, or orthostatic tachycardia, as well as patients with a previous history of these conditions, at screening or before randomization.\n28. A history of persistent or active syncope after urination\u002Fdefecation, a previous known history of syncope, or a concomitant medical condition that increases the risk of syncope.\n29. Bilirubin, transaminase, blood routine and other abnormalities exceed the requirements during screening.\n30. An electrocardiogram showed a heart rate of less than 55 beats per minute before screening or randomization or a QT interval of at least 500 msec or a QTcF interval of at least 450 msec before randomization.\n31. Allergy to drugs in the same class or to any component of HRS-9813.\n32. Other reasons for not participating in the study as judged by the investigator.","21 Years",{"count":297,"type":21},270,[24],"To evaluate the efficacy and safety of HRS-9813 in subjects with pulmonary fibrosis。",[301],"IPF and PPF","2025-12-18",{"date":304,"type":32},"2025-12-24",{"date":306,"type":32},"2025-10-29",{"date":308,"type":21},"2028-06",{"name":38,"class":39},{"id":311,"slug":312,"hasResults":11,"nctId":313,"briefTitle":314,"officialTitle":315,"acronym":4,"eligibilityCriteria":316,"healthyVolunteers":11,"sex":16,"minAge":48,"maxAge":4,"enrollmentInfo":317,"targetDuration":4,"studyType":22,"phases":319,"briefSummary":320,"conditions":321,"keywords":4,"overallStatus":78,"whyStopped":4,"lastUpdateSubmitDate":323,"lastUpdatePostDateStruct":324,"startDateStruct":325,"completionDateStruct":327,"leadSponsor":329,"locationsCount":40},"100550034","phase-2-a-study-to-evaluate-the-long-term-safety-pharmacodynamics-and-efficacy-of-shr-1703-in-eosinophilic-asthma-patients-100550034","NCT06441812","A Study to Evaluate the Long-term Safety, Pharmacodynamics and Efficacy of SHR-1703 in Eosinophilic Asthma Patients","A Multicenter, Single-group Phase II Clinical Study to Evaluate the Long-term Safety, Pharmacodynamics and Efficacy of Multiple Subcutaneous Injections of SHR-1703 in Eosinophilic Asthma Patients","Inclusion Criteria:\n\n1. At least 18 years of age, Male or Femal.\n2. A minimum weight of 40kg.\n3. Subjects with the clinical features of asthma that meets the diagnostic criteria of the \"Guidelines for the Prevention and Treatment of Bronchial Asthma (2020 Edition)\" and has a medical history of at least 1 year.\n4. Documentation of current asthma controller medication \\[medium or high dose ICS and at least one of additional controller such as long-acting muscarinic antagonist (LAMA), long-acting beta2-agonist (LABA) and leukotriene receptor antagonist (LTRA)\\] for at least 1 stable month before first administration of SHR-1703.\n5. At least one confirmed history of exacerbation within one year of initial administration of SHR-1703, occurring during the use of medium and high daily dose ICS.\n6. Absolute count of eosinophils must be ≥0.15×109\u002FL at visit 0 and visit 1.\n7. A pre-bronchodilator FEV1 \\\u003C85% and ≥30% predicted at visit 0 and visit 1.\n8. Female subjects with fertility agree to have no plan pregnancy and voluntarily adopt high-efficiency contraception measures from signing the informed consent form to 14 months after the last dose of SHR-1703, and male subjects with fertility as partners agree to have no plan pregnancy and voluntarily adopt high-efficiency contraception measures between the first dose of SHR-1703 and the last visit in the study.\n9. Subjects must be able to give written informed consent prior to participation in the study.\n\nExclusion Criteria:\n\n1. Presence of a clinically important lung condition. This includes but is not limited to current infection, bronchiectasis, pulmonary fibrosis or a history of lung cancer.\n2. A known immunodeficiency.\n3. Presence of a clinically significant and uncontrolled serious cardiovascular and cerebrovascular disease, including but not limited to myocardial infarction, unstable angina, heart failure, stroke, and subarachnoid haemorrhage.\n4. Within the first 4 weeks before visit 0, presence of exacerbation of allergic rhinitis or sinusitis, or a history of infections with clinical significance and\u002For requiring clinical intervention, including but not limited to respiratory infections.\n5. A known parasitic infection within the first 6 months before visit 0.\n6. A malignancy history within the first 5 years before visit 0 (Subjects that had localized basal carcinoma of the skin or cervical carcinoma in situ which was resected for cure will not be excluded).\n7. Blood donation or significant blood loss (≥ 400ml) within the first 4 weeks before visit 0, or infusion of blood products or immunoglobulins.\n8. Use systemic immunosuppressants (excluding systemic glucocorticoids used for asthma treatment and for non asthma treatment for less than 3 days) or immunomodulators, or biologics or Th2 cytokine inhibitors, including but not limited to methotrexate, cyclosporine, interferon-α, anti IL-5 monoclonal antibodies (including SHR-1703), anti IL-4R monoclonal antibodies, anti TSLP monoclonal antibodies, anti IgE monoclonal antibodies, metformin, etc., and within 5 half-lives of the drug before the first administration (refer to the longer drug instructions; for those with unknown half-lives, 12 weeks before the first administration shall prevail);\n9. Subjects who have previously participated in any study and received Investigational Product within the first 30 days before visit 0.\n10. There was a surgical plan or other treatment measures that the researcher believed may affect the subject's evaluation during the study period.\n11. Laboratory examination shows obvious abnormalities at visit 0 and visit 1:\n\n    1. White blood cell count (WBC) \\\u003C3.0×109\u002FL;\n    2. Hemoglobin≤90g\u002FL；\n    3. Platelet\\\u003C100×109\u002FL；\n    4. Alanine aminotransferase (ALT)\\>2×ULN (upper limit of normal);\n    5. Aspartate aminotransferase (AST) \\>2×ULN；\n    6. Total bilirubin (TBIL)\\>1.5×ULN;\n    7. Prothrombin time (PT) \\>ULN+3s；\n    8. Creatinin\\>1.5×ULN;\n    9. Active hepatitis B (positive for hepatitis B virus deoxyribonucleic acid (HBV DNA) in peripheral blood), or positive for hepatitis C virus antibody, or positive for human immunodeficiency virus (HIV) antibody, or positive for treponema pallidum antibody；\n12. ECG QTc\\>450ms or other clinically significant abnormal results that may pose significant safety risks to the subjects at visit 0 or visit 1；\n13. A history of drug addicts or substance abuse within 1 years prior to Visit 0；\n14. Subjects who are pregnant (positive HCG test at visit 0 or visit 1) or breastfeeding should not be enrolled if they plan to become pregnant during the time of study participation；\n15. Subjects with a known allergy or intolerance to anti IL-5 monoclonal antibody or other biologic；\n16. Other reasons determined by the researcher as unsuitable for participation in the study.",{"count":318,"type":21},200,[24],"The purpose of this study is to evaluation the long-term Safety, Pharmacodynamics and Efficacy of SHR-1703 in Eosinophilic Asthma Patients",[322],"Eosinophilic Asthma Patients","2025-12-11",{"date":302,"type":32},{"date":326,"type":32},"2024-07-19",{"date":328,"type":21},"2028-09",{"name":38,"class":39},{"id":331,"slug":332,"hasResults":11,"nctId":333,"briefTitle":334,"officialTitle":334,"acronym":4,"eligibilityCriteria":335,"healthyVolunteers":11,"sex":16,"minAge":216,"maxAge":4,"enrollmentInfo":336,"targetDuration":4,"studyType":22,"phases":338,"briefSummary":339,"conditions":340,"keywords":4,"overallStatus":78,"whyStopped":4,"lastUpdateSubmitDate":342,"lastUpdatePostDateStruct":343,"startDateStruct":345,"completionDateStruct":347,"leadSponsor":348,"locationsCount":40},"100566295","phase-3-a-multi-centeredrandomizeddouble-blindplacebo-controlled-study-to-evaluate-the-efficacy-and-safety-of-shr-1703-in-eosinophilic-asthma-100566295","NCT06653322","A Multi-centered，Randomized，Double-blind，Placebo-controlled Study to Evaluate the Efficacy and Safety of SHR-1703 in Eosinophilic Asthma","Inclusion Criteria:\n\n1. At least 12 years of age\n2. A minimum weight of 40kg\n3. A medical history of at least 1 year that meets the diagnosis of asthma;\n4. Current treatment with medium- or high- doses of ICS for at least 6 months and using steadily at least 3 months\n5. Current treatment with an additional controller medication, besides ICS, for at least 3 months and using steadily at least 1 month\n6. Absolute count of blood eosinophils suggests eosinophilic asthma\n7. During the screening period and baseline, pre- BD FEV1% \\\u003C 80%\n8. During the screening period and baseline, ACQ-6 score indicates asthma poor control\n9. History of severe asthma exacerbation within the past 12 months prior to screening\n10. Good compliance with eDiary completion\n11. Take efficient contraceptive measures\n12. Voluntarily sign the informed consent form to participate in this study\n\nExclusion Criteria:\n\n1. With other condition that could lead to elevated eosinophils\n2. With Clinically significant pulmonary diseases\n3. With existing immunodeficiency disease\n4. With other clinically significant diseases that may affect lung function\n5. With uncontrolled severe cardiovascular and cerebrovascular diseases\n6. With uncontrolled hypertension and\u002For diabetes\n7. With exacerbation, allergic rhinitis or sinusitis attacks, or clinical significant infection requiring intervention during 4 weeks prior to randomization\n8. Recent major surgeries or surgical plans during the study period, or treatment measures that investigators believe may affect subject evaluation\n9. Existing parasitic infections\n10. Diagnosed as malignant tumor within the first 5 years of randomization\n11. Significant abnormalities in screening period or baseline laboratory tests\n12. Screening period or baseline ECG QTc prolongation\n13. Prohibited drugs using during the pre randomization period\n14. Participated in other clinical trials within 30 days prior to screening and used research drugs containing active ingredients, or was still within 5 half lives of the research drug at the time of screening\n15. Smoking or quitting smoking for less than 6 months during screening, or previous smoking history ≥ 10 pack years\n16. History of drug use, alcoholism, or substance abuse within the past year prior to screening\n17. Allergic or intolerant to IL-5 monoclonal antibodies or other biological agents\n18. Pregnant or lactating subjects\n19. Other reasons why the researcher deemed it unsuitable for conducting this experiment",{"count":337,"type":21},400,[177],"The purpose of this study is to evaluate the Pharmacodynamic, Efficacy and Safety of SHR-1703 in Asthma Patients with Eosinophil Phenotype",[341],"Asthma With Eosinophilic Phenotype","2025-12-09",{"date":344,"type":32},"2025-12-10",{"date":346,"type":32},"2024-11-21",{"date":61,"type":21},{"name":38,"class":39},{"id":350,"slug":351,"hasResults":11,"nctId":352,"briefTitle":353,"officialTitle":354,"acronym":4,"eligibilityCriteria":355,"healthyVolunteers":11,"sex":16,"minAge":48,"maxAge":356,"enrollmentInfo":357,"targetDuration":4,"studyType":22,"phases":359,"briefSummary":360,"conditions":361,"keywords":4,"overallStatus":78,"whyStopped":4,"lastUpdateSubmitDate":363,"lastUpdatePostDateStruct":364,"startDateStruct":366,"completionDateStruct":368,"leadSponsor":370,"locationsCount":40},"100610604","phase-2-a-phase-ii-clinical-study-on-the-efficacy-and-safety-of-shr-2173-injection-in-the-treatment-of-patients-with-active-lupus-nephritis-100610604","NCT07229742","A Phase II Clinical Study on the Efficacy and Safety of SHR-2173 Injection in the Treatment of Patients With Active Lupus Nephritis","A Randomized, Double-blind, Placebo-controlled, Multicenter Phase II Clinical Study to Evaluate the Efficacy and Safety of SHR-2173 Injection in Patients With Active Lupus Nephritis","Inclusion Criteria:\n\n1. Age 18-70 years (inclusive) at informed consent signing, regardless of sex;\n2. Body weight ≥ 40.0 kg and body mass index (BMI) ≥ 16 kg\u002Fm² to ≤ 28 kg\u002Fm² at screening;\n3. Diagnosed with systemic lupus erythematosus (SLE) per 1997 ACR criteria or 2019 EULAR\u002FACR classification criteria;\n4. Positive antinuclear antibody (titer ≥ 1:80) and\u002For anti-dsDNA antibody and\u002For anti-Sm antibody at screening;\n5. Histologically confirmed active lupus nephritis (LN) class III or IV ± class V by renal biopsy, per 2018 International Society of Nephrology\u002FRenal Pathology Society (ISN\u002FRPS) standards within 1 year preceding or during screening.\n\nExclusion Criteria:\n\n1. Received renal dialysis within 12 months preceding screening, or anticipated requirement for dialysis\u002Frenal transplantation within 6 months post-enrollment;\n2. Renal biopsy demonstrating \\> 50% globally sclerosed glomeruli;\n3. Active severe\u002Funstable neuropsychiatric SLE (NPSLE);\n4. Catastrophic antiphospholipid syndrome (APS) within 12 months pre-screening, or APS-related thrombotic events (except non-catastrophic\u002Fmild APS cases with stable anticoagulation ≥12 weeks prior to screening);\n5. Non-LN renal diseases potentially confounding disease assessment (e.g., diabetic nephropathy per investigator judgment);\n6. Inflammatory\u002Fautoimmune diseases beyond SLE\u002FLN that may interfere with efficacy\u002Fsafety interpretation.","70 Years",{"count":358,"type":21},51,[24],"The study is a Phase II clinical trial to evaluate the efficacy and safety of SHR-2173 in patients with lupus nephritis (LN). It adopts a randomized, double-blind, placebo-controlled, multicenter trial design.",[362],"Active Lupus Nephritis","2025-11-28",{"date":365,"type":32},"2025-12-01",{"date":367,"type":32},"2025-11-22",{"date":369,"type":21},"2028-03",{"name":38,"class":39},{"id":372,"slug":373,"hasResults":11,"nctId":374,"briefTitle":375,"officialTitle":376,"acronym":4,"eligibilityCriteria":377,"healthyVolunteers":11,"sex":16,"minAge":48,"maxAge":4,"enrollmentInfo":378,"targetDuration":4,"studyType":22,"phases":380,"briefSummary":381,"conditions":382,"keywords":4,"overallStatus":78,"whyStopped":4,"lastUpdateSubmitDate":384,"lastUpdatePostDateStruct":385,"startDateStruct":387,"completionDateStruct":389,"leadSponsor":391,"locationsCount":63},"100514480","phase-2-a-study-to-evaluate-the-efficacy-and-safety-of-shr-1703-in-subjects-with-eosinophilic-granulomatosis-with-polyangiitis-egpa-100514480","NCT05979051","A Study to Evaluate the Efficacy and Safety of SHR-1703 in Subjects With Eosinophilic Granulomatosis With Polyangiitis （EGPA）","A Multicenter, Single-arm\u002FRandomized, Double-blind, Active-controlled, Parallel-group Phase 2\u002F3 Clinical Study to Evaluate the Efficacy and Safety of SHR-1703 for Patients With EGPA","Inclusion Criteria:\n\n1. Male or female subjects age 18 years or older;\n2. Diagnosed with EGPA for at least 6 months;\n3. History of relapsing or refractory EGPA；\n4. Stable dose of oral prednisone of ≥7.5 mg\u002Fday (but not \\>50 mg\u002Fday) for at least 4 weeks prior to randomization;\n5. If receiving immunosuppressive therapy (excluding cyclophosphamide), the dosage must be stable within 4 weeks prior to randomization and during the study.\n\nExclusion Criteria:\n\n1. Subjects with other eosinophilic-related diseases;\n2. Diagnosed with granulomatosis with polyangiitis (GPA) or microscopic polyangiitis (MPA).\n3. Life-threatening EGPA within 3 months prior to randomization;\n4. Malignancy history within 5 years prior to randomization;\n5. Immunodeficiency;\n6. Uncontrolled hypertension；\n7. Uncontrolled cerebrovascular and cardiovascular disease;\n8. parasitic infection within 6 months prior to randomization;\n9. Active infectious disease requiring clinical treatment within 4 weeks prior to randomization;\n10. Subjects with a dose of oral prednisone of \\>50 mg\u002Fday within 4 weeks prior to randomization;\n11. Oral or intravenous cyclophosphamide therapy within 4 weeks prior to randomization;\n12. Intravenous or subcutaneous immunoglobulin within 12 weeks prior to randomization;\n13. Biological agents or TH2 cytokine inhibitors used within 12 weeks prior to randomization or within 5 half-lives of the drug;\n14. Rituximab used within 6 months prior to randomization；\n15. Surgical plans that might affect the evaluation;\n16. Significant laboratory abnormalities；\n17. Prolonged QTc interval or other electrocardiogram abnormalities with significant safety risk at screening;\n18. History of drug or substance abuse or alcohol abuse within 1 year prior to screening;\n19. Subjects participated another clinical study and received active drug within 30 days or 5 half-lives of the drug prior to screening;\n20. Subjects is pregnant, lactating, or planning to be pregnant;\n21. Subjects have a known history of hypersensitivity or intolerance to anti-IL-5 mabs or other biological agents or previous failure of IL-5\u002FIL-5R therapy;\n22. Other conditions unsuitable for participation in the study per investigator judgement.",{"count":379,"type":21},166,[24,177],"This study is a phase 2\u002F3 clinical trial to evaluate the efficacy and safety of SHR-1703 in patients with EGPA.",[383],"Eosinophilic Granulomatosis With Polyangiitis","2025-11-26",{"date":386,"type":32},"2025-12-04",{"date":388,"type":32},"2023-11-16",{"date":390,"type":21},"2028-12",{"name":38,"class":39},{"id":393,"slug":394,"hasResults":11,"nctId":395,"briefTitle":396,"officialTitle":397,"acronym":4,"eligibilityCriteria":398,"healthyVolunteers":11,"sex":16,"minAge":48,"maxAge":49,"enrollmentInfo":399,"targetDuration":4,"studyType":22,"phases":401,"briefSummary":402,"conditions":403,"keywords":4,"overallStatus":78,"whyStopped":4,"lastUpdateSubmitDate":405,"lastUpdatePostDateStruct":406,"startDateStruct":408,"completionDateStruct":410,"leadSponsor":411,"locationsCount":40},"100603154","phase-3-efficacy-and-safety-of-shr-1905-injection-in-subjects-with-chronic-rhinosinusitis-with-nasal-polyps-100603154","NCT07132827","Efficacy and Safety of SHR-1905 Injection in Subjects With Chronic Rhinosinusitis With Nasal Polyps","A Multicentre, Randomised, Double-Blind, Placebo-Controlled, Parallel-Group Phase 3 Efficacy and Safety Study of SHR-1905 in Patiens With Chronic Rhinosinusitis With Nasal Polyps","Inclusion Criteria:\n\n1. Weight ≥40kg\n2. Diagnosed with chronic rhinosinusitis with nasal polyps (CRSwNP).\n3. Bilateral nasal polyps at screening and baseline, total NPS ≥5, ≥2 points for each nostril.\n4. NCS ≥2 at screening and baseline.\n5. SNOT-22≥30 at screening period and baseline.\n6. Recorded persistent NP symptoms for over 4 weeks prior to screening.\n7. Subjects received standard therapy with intranasal corticosteroids (INCS) prior to randomization.\n8. NP surgery in the past and\u002For SCS use within 1 years before screening(or with contraindications\u002F intolerances).\n\nExclusion Criteria:\n\n1. Any comorbidities that may affect the efficacy evaluation of nasal polyps.\n2. Any comorbidities except for asthma that may affect blood EOS levels.\n3. Concomitant with immunodeficiency.\n4. Concomitant with contraindications or not suitable for nasal endoscopy.\n5. Uncontrolled hypertension and\u002For uncontrolled diabetes.\n6. Concomitant with infection within 4 weeks prior to randomization.\n7. Uncontrolled epistaxis within 4 weeks prior to randomization.\n8. Major surgery performed within 3 months prior to randomization, or surgery planned during the study, or treatments that may affect evaluations according to investigators.\n9. Parasitic infection within 6 months before randomization.\n10. Sinus or intranasal surgery within 6 months prior to screening, or changes in the nasal walls caused by sinus or intranasal surgery that made NPS evaluation impossible.\n11. Malignancies diagnosed within 5 years before randomization (except those with a low risk of metastasis or death).\n12. Abnormalities of laboratory tests at screening or baseline.\n13. Concomitant with active hepatitis B, positive hepatitis C virus antibodies, positive human immunodeficiency virus antibodies, or positive treponema pallidum antibodies.\n14. Prolonged QTc interval or other clinically significant abnormal results of ECG at screening or baseline that may cause significant safety risks to subjects.\n15. FEV1 before the use of bronchodilator (pre-BD) was less than 50% at screening.\n16. Transfusion of blood products or immunoglobulin within 4 weeks prior to randomization.\n17. SCS or additional INCS use within 4 weeks before randomization, or planned use during treatment period.\n18. Regular use of decongestants (local or systemic) within 4 weeks before randomization, except for during the endoscopic procedure.\n19. Adnimistration of live vaccine or viral vector vaccine within 4 weeks before randomization.\n20. Allergen immunotherapy within 8 weeks before randomization.\n21. Smoking at screening, or smoking cessation less than 6 months at screening.\n22. Substance abuse, drug abuse, and\u002For excessive alcohol consumption within 1 year prior to randomization.\n\nPregnancy (including positive pregnancy test at screening or baseline), lactation, or pregnancy plan during study period.",{"count":400,"type":21},280,[177],"The study is being conducted to evaluate the efficacy, and safety of SHR-1905 injection in subjects with chronic rhinosinusitis with nasal polyps (CRSwNP)",[404],"Chronic Rhinosinusitis With Nasal Polyps","2025-11-14",{"date":407,"type":32},"2025-11-17",{"date":409,"type":32},"2025-08-28",{"date":249,"type":21},{"name":38,"class":39},{"id":413,"slug":414,"hasResults":11,"nctId":415,"briefTitle":416,"officialTitle":417,"acronym":4,"eligibilityCriteria":418,"healthyVolunteers":11,"sex":16,"minAge":48,"maxAge":4,"enrollmentInfo":419,"targetDuration":4,"studyType":22,"phases":421,"briefSummary":422,"conditions":423,"keywords":4,"overallStatus":78,"whyStopped":4,"lastUpdateSubmitDate":425,"lastUpdatePostDateStruct":426,"startDateStruct":428,"completionDateStruct":430,"leadSponsor":431,"locationsCount":40},"100600508","phase-3-a-trial-of-shr-1905-in-subjects-with-severe-uncontrolled-asthma-100600508","NCT07098403","A Trial of SHR-1905 in Subjects With Severe Uncontrolled Asthma","A Multicentre, Randomized, Double-blind, Placebo-controlled, Parallel Group Phase Ⅲ Study to Evaluate the Efficacy and Safety of SHR-1905 in Subjects With Severe Uncontrolled Asthma","Inclusion Criteria:\n\n1. Age ≥ 18.\n2. Documented physician-diagnosed asthma for at least 12 months.\n3. Participants who have received asthma controller medication with medium or high dose ICS for at least 6 months.\n4. Documented treatment with a total daily dose of either medium or high dose ICS (Refer to Guidelines for the prevention and management of bronchial asthma (2024 edition)) for at least 3 months.\n5. At least one additional maintenance asthma controller medication is required according to standard practice of care and must be documented for at least 3 months.\n6. Pre-BD FEV1 \\\u003C 80% predicted normal.\n7. Objective evidence of asthma as documented.\n8. Documented history of at least 2 asthma exacerbation events within 12 months, and at least one of the exacerbations should occur during the treatment of medium-to-high dose ICS.\n9. ACQ-6 score ≥ 1.5 at screening and on day of baseline.\n10. ePRO adherence ≥ 70% in the 7 days prior to randomization.\n\nExclusion Criteria:\n\n1. Clinically significant pulmonary disease other than asthma.\n2. History of cancer.\n3. History of a clinically significant infection.\n4. Current smokers or participants with smoking history ≥ 10 pack-yrs.\n5. History of chronic alcohol or drug abuse within 12 months.\n6. Hepatitis B, C or HIV.\n7. Pregnant or breastfeeding.\n8. History of anaphylaxis following any biologic therapy.\n9. participant randomized in the current study or previous SHR-1905 studies.",{"count":420,"type":21},408,[177],"This study is a phase III study of SHR-1905 in subjects with severe uncontrolled asthma. The purpose of the study is to evaluate efficacy and safety of SHR-1905 in subjects with severe uncontrolled asthma.",[424],"Asthma","2025-09-08",{"date":427,"type":32},"2025-09-09",{"date":429,"type":32},"2025-09-03",{"date":308,"type":21},{"name":38,"class":39},{"id":433,"slug":434,"hasResults":11,"nctId":435,"briefTitle":436,"officialTitle":437,"acronym":4,"eligibilityCriteria":438,"healthyVolunteers":11,"sex":16,"minAge":48,"maxAge":49,"enrollmentInfo":439,"targetDuration":4,"studyType":22,"phases":441,"briefSummary":442,"conditions":443,"keywords":4,"overallStatus":78,"whyStopped":4,"lastUpdateSubmitDate":445,"lastUpdatePostDateStruct":446,"startDateStruct":447,"completionDateStruct":449,"leadSponsor":451,"locationsCount":40},"100599966","phase-2-a-clinical-study-on-the-efficacy-safety-pharmacokinetics-and-pharmacodynamics-of-shr-1819-injection-in-patients-with-seasonal-allergic-rhinitis-100599966","NCT07091357","A Clinical Study on the Efficacy, Safety, Pharmacokinetics and Pharmacodynamics of SHR-1819 Injection in Patients With Seasonal Allergic Rhinitis","A Multicenter, Randomized, Double-blind, Placebo-controlled Phase II Clinical Study to Evaluate the Efficacy, Safety, Pharmacokinetics and Pharmacodynamics of SHR-1819 Injection in Patients With Seasonal Allergic Rhinitis","Inclusion Criteria:\n\n1. At the time of signing the informed consent form, the age is 18 to 75 years old.\n2. Meet the diagnostic criteria for seasonal allergic rhinitis (SAR) as defined in the Chinese Guidelines for the Diagnosis and Treatment of Allergic Rhinitis (2022, Revised Edition), with or without allergic conjunctivitis, and have a disease duration of at least 2 years.\n3. At the screening visit, the investigator assesses that the subject had poor efficacy with intranasal glucocorticoids and\u002For other medications for allergic rhinitis (antihistamines, leukotriene receptor antagonists, etc.) during the same pollen season in the past.\n4. The subject has an immunoglobulin E (IgE)-mediated hypersensitivity to at least one pollen allergen in the current season or the same period, which can be confirmed based on the skin prick test (SPT) and\u002For serum specific IgE results during the screening period (test results within 1 year before randomization are acceptable).\n5. Willing and able to complete the patient diary as required by the protocol during the study period.\n6. Female subjects of childbearing potential and male subjects whose partners are females of childbearing potential agree to use the contraceptive measures specified in the protocol from the signing of the ICF until 3 months after the last administration.\n\nExclusion Criteria:\n\n1. During screening or within 2 weeks prior to the screening visit, the subject has other active rhinitis excluding SAR, including but not limited to infectious rhinitis, drug-induced rhinitis, vasomotor rhinitis, non-allergic rhinitis with eosinophilia syndrome, dry rhinitis, atrophic rhinitis, etc.\n2. During screening or within 2 weeks prior to the screening visit, there may be other nasal comorbidities or concurrent diseases\u002Fstates that could affect the judgment of efficacy (including but not limited to nasal polyps, cerebrospinal fluid rhinorrhea, severe nasal septal deviation, status after nasal or sinus surgery within 1 year, etc.), acute\u002Fchronic sinusitis (except those deemed non-influential by the investigator), or upper respiratory tract infections.\n3. During screening, there is glaucoma, cataract, ocular simple herpes, other ocular infections such as infectious conjunctivitis, acute conjunctivitis, acute keratitis (except for symptoms related to allergic rhinitis).\n4. During the screening visit, subjects with perennial allergic rhinitis (PAR) allergic to pet hair are included; if the subject currently has no contact with pet hair, they can be enrolled.\n5. Subjects with severe asthma who are receiving treatment with inhaled glucocorticoids (ICS) at a daily high dose or equivalent of more than twice the standard dose.\n6. Subjects who initiated ICS treatment for asthma within 4 weeks prior to the screening visit. If the subject has been treated with a stable dose of ICS for at least 4 weeks before the screening visit, and the ICS dosage does not exceed twice the daily high dose, and the investigator assesses that the asthma remains well-controlled during the study while maintaining this dosage, such subjects may be screened.\n7. Within 3 months prior to the screening visit, the subject had an acute exacerbation of asthma requiring hospitalization for more than 24 hours.\n8. Within 6 months prior to the screening visit, the subject has a history of vernal keratoconjunctivitis (VKC) and\u002For atopic keratoconjunctivitis (AKC).\n9. Within 1 week prior to randomization, the subject has received treatment with the following medications: leukotriene receptor antagonists. If the subject has been stably using mast cell membrane stabilizers, decongestants, nasal anticholinergic drugs, or other nasal preparations that may affect SAR assessment for ≥1 week at the time of screening, they may be included.\n10. Within 2 weeks prior to the screening visit, the subject has used monoamine oxidase inhibitors.\n11. Within 4 weeks prior to the screening visit, the subject has received the following treatments: systemic glucocorticoids, systemic immunosuppressants (including but not limited to hydroxychloroquine, cyclosporine, azathioprine, methotrexate, cyclophosphamide, tacrolimus, etc.), systemic traditional Chinese medicines (including proprietary Chinese medicines) for treating allergic rhinitis, and tricyclic antidepressants.\n12. Within 4 weeks prior to the screening visit, the subject initiated immunotherapy or plans to receive immunotherapy during the study. If the subject has maintained a stable dose of immunotherapy for 4 weeks before screening and can continue this dose throughout the study, they may be enrolled.\n13. Within 8 weeks prior to the screening visit or within 5 half-lives (if the half-life is known) of receiving investigational drugs or medical devices, whichever is longer. If the subject participated in a clinical study but only signed the informed consent form, and it can be proven that screening failed and no medication was administered, they may be enrolled.\n14. Within 3 months prior to the screening visit, the subject has received or been exposed to other live vaccines or live attenuated vaccines, or participated in a vaccine clinical trial.\n15. Within 6 months prior to the screening visit, the subject has used other biological agents.\n16. Within 1 week prior to the screening visit, the subject requires systemic antimicrobial treatment (for viral, bacterial, fungal, or parasitic infections).\n17. At the time of screening and within 2 weeks prior to screening, positive results for human immunodeficiency virus antibody (HIV), syphilis antibody, and hepatitis C virus (HCV) antibody; hepatitis B virus (HBV) infection meets the following (test results within 2 weeks prior to screening are acceptable).\n18. Within 3 months prior to the screening visit, the subject has undergone major surgery, or plans to undergo major surgery during the study period.\n19. Within 6 months prior to the screening visit, the subject was diagnosed with active tuberculosis.\n20. Within 6 months prior to the screening visit, the subject was diagnosed with or the investigator determined the presence of suspected immunosuppressive diseases.\n21. Within 1 year prior to the screening visit, the subject has a history of recurrent herpes zoster or Kaposi varicelliform eruption (≥2 times), disseminated herpes zoster, or disseminated herpes simplex.\n22. Has or has a history of malignant tumor (except for cutaneous squamous cell carcinoma, basal cell carcinoma, or cervical in situ carcinoma that has been completely resected and shows no evidence of recurrence).\n23. Accompanied by other severe or chronic diseases that are poorly controlled.\n24. Pregnant or lactating women.\n25. Within 6 months prior to screening, the subject has a history of alcohol abuse.\n26. The investigator determines that there are conditions affecting the safety and efficacy evaluation of the study drug, as well as any other circumstances that may lead to the patient's non-compliance with the trial procedures and log filling.",{"count":440,"type":21},100,[24],"This is a trial to evaluate the safety and efficacy of SHR-1819 injection in the treatment of patients with seasonal allergic rhinitis.",[444],"Seasonal Allergic Rhinitis","2025-09-01",{"date":429,"type":32},{"date":448,"type":32},"2025-08-06",{"date":450,"type":21},"2025-12",{"name":38,"class":39},{"id":453,"slug":454,"hasResults":11,"nctId":455,"briefTitle":456,"officialTitle":457,"acronym":4,"eligibilityCriteria":458,"healthyVolunteers":11,"sex":16,"minAge":48,"maxAge":49,"enrollmentInfo":459,"targetDuration":4,"studyType":22,"phases":460,"briefSummary":461,"conditions":462,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":463,"lastUpdatePostDateStruct":464,"startDateStruct":466,"completionDateStruct":468,"leadSponsor":469,"locationsCount":40},"100588384","phase-2-clinical-study-on-the-efficacy-and-safety-of-shr-4597-inhalant-in-adult-patients-with-asthma-100588384","NCT06940700","Clinical Study on the Efficacy and Safety of SHR-4597 Inhalant in Adult Patients With Asthma","To Evaluate the Efficacy and Safety of SHR-4597 Inhalants in Adults With Asthma: a Multicenter, Randomized, Open-label, Positive-controlled Phase II Clinical Study","Inclusion Criteria:\n\n1. Age ≥18 years old and ≤75 years old, gender is not limited;\n2. Body mass index (BMI) ≥18 and ≤30 kg\u002Fm2 during screening period;\n3. Medical history and objective evidence consistent with current guidelines supporting an asthma diagnosis within the 12 months prior to randomization;\n4. Did not receive inhaled corticosteroids (ICS) and\u002For combined with other asthma control medications within 2 weeks prior to randomization;\n5. FEV1 during the screening period and before bronchodilator inhalation at baseline accounted for ≥40% and \\\u003C 80% of the estimated value;\n6. Screening and baseline visit, Asthma Control Questionnaire-6 (ACQ-6) score ≥1.5;\n7. FeNO values at screening period and baseline ≥25 ppb;\n8. Patients with asthma who were treated for the first time or who had previously taken irregular medication were selected; Among them, the definition of irregular past use was: patients did not regularly use asthma control drugs within the first 3 months of enrollment, and the average weekly use compliance was \\\u003C 50%.\n9. A fertile female subject or a male subject whose partner is a fertile female must agree not to have a family plan and to voluntarily use highly effective contraception (including the partner) from the time of signing the informed consent until 1 month after the last study drug administration, and refrain from sperm\u002Fegg donation;\n10. Voluntarily sign informed consent to participate in this study.\n11. The subjects were unable to complete the questionnaires due to their limited educational level, or neither the subjects themselves nor their families could fill in the subject log card.\n12. The researchers determined that there were other circumstances that were not suitable for participation in this study.\n\nExclusion Criteria:\n\n1. Combined diseases or conditions\n\n   * Clinically significant pulmonary diseases, including but not limited to active pulmonary tuberculosis, bronchiectasis, atelectasis, idiopathic pulmonary fibrosis, bronchopulmonary aspergillosis, and chronic obstructive pulmonary disease (COPD);\n\n     * Malignant tumors diagnosed within 5 years prior to randomization (except those with a low risk of metastasis and death, such as well-treated basal cell carcinoma of the skin or carcinoma in situ of the cervix);\n\n       * Combined with poorly controlled hypertension (systolic blood pressure ≥180mmHg, and\u002For diastolic blood pressure ≥110mmHg during the screening period) or uncontrolled severe cardiovascular and cerebrovascular diseases; ④ Known immunodeficiency;\n\n         * A history of infection requiring clinical intervention within 4 weeks prior to randomization, including but not limited to respiratory infection;\n\n           ⑥ Known presence of parasitic infection within 6 months prior to randomization;\n\n           ⑦ Blood donation or significant blood loss (≥400ml), or transfusion of blood products or immunoglobulin within 4 weeks prior to randomization;\n\n           ⑧ A history of life-threatening acute asthma attacks (including admission to the intensive care unit and\u002For the need for invasive ventilator support \\[intubation\u002Ftracheotomy\\]);\n\n           ⑨ History of acute asthma attack in the 4 weeks prior to randomization.\n2. Combination of medication or treatment\n\n   * Receiving non-selective beta-blockers (e.g., propranolol) within 1 week prior to screening;\n\n     * Live attenuated vaccine or recombinant vaccine with viral vector were received within 4 weeks before randomization;\n\n       * Receiving allergen immunotherapy 8 weeks before randomization;\n\n         * Within 12 weeks before randomization or within 5 half-lives of the drug (refer to the drug instructions, whichever is older; For those with unknown half-lives, the first 12 weeks of randomization will be the use of systemic immunosuppressants (except for systemic glucocorticoids for asthma treatment, and systemic glucocorticoids for other conditions \\\u003C3 days) or immunomodulators, or biologics or Th2 cytokine inhibitors, Including but not limited to methotrexate, cyclosporine, interferon-alpha, anti-IL-5 monoclonal antibody,anti-TSLP monoclonal antibody, anti-IGE monoclonal antibody, mesulast, etc.\n\n           * Receiving a single dose of long-acting β2 agonist within 4 weeks prior to screening; ⑥4 weeks before randomization, inhaled corticosteroids (\\>500 micrograms of beclomethasone dipropionate per day \\[BDP\\] or equivalent dose);\n\n             ⑦4 weeks before randomization, systemic glucocorticoid therapy;\n             * Received bronchial thermoplasty or bronchial cryoablation within 1 year before randomization; ⑨There is a surgical plan during the study, or other treatment that the investigator believes may affect the evaluation of the subject;\n3. Laboratory examination\n\n   ①Significant abnormalities during screening or baseline laboratory tests:\n   1. White blood cell (WBC) \\\u003C 3.0×109\u002FL;\n   2. Blood eosinophils \\>1500cells\u002FμL (1.5×109\u002FL)\n   3. Hemoglobin (Hb) ≤90 g\u002FL;\n   4. Alanine aminotransferase (ALT) \\> 3×ULN (upper limit of normal);\n   5. Aspartate aminotransferase (AST) \\> 3×ULN;\n   6. Total bilirubin (TBIL) \\> 1.5×ULN;\n   7. Prothrombin time (PT) \\> ULN+3s;\n   8. Creatinine (Cr) \\> 1.5×ULN;\n   9. Co-active hepatitis B (peripheral blood hepatitis B virus deoxyribonucleic acid (HBV DNA) ≥1×103 IU\\[or copy\\] \u002F mL), or hepatitis C antibody positive, or human immunodeficiency virus (HIV) positive, or treponema pallidum antibody positive.\n\n      * Prolonged ECG QTc interval (\\>450ms) or other clinically significant abnormal results that may pose significant safety risks to subjects during the screening period;\n4. General situation\n\n   * Smoking or smoking cessation less than 6 months during the screening period, or previous smoking ≥10 pack years (pack years = number of years of smoking × number of packs per day); ②A history of drug use, alcohol abuse (average weekly consumption of ≥14 units of alcohol: 1 unit = 285 mL for beer, 25 mL for spirits, or 100 ml for wine) or drug abuse in the year prior to screening;\n\n     * Have participated in other clinical studies and used investigational drugs containing active ingredients within 30 days prior to screening, or have been within 5 half-lives of investigational drugs at the time of screening (whichever is older);\n\n       * Subjects who are pregnant (screening or baseline blood pregnancy test positive) or who plan to become pregnant while breastfeeding or during the study; ⑥Other reasons deemed unsuitable for study participation by the researcher.\n       * Excessive alcohol consumption and drug abuse were prohibited throughout the study period (the definition of excessive alcohol consumption is the same as exclusion criterion IV.2).\n\n         * Smoking (including e-cigarettes) was prohibited throughout the study period.",{"count":51,"type":21},[24],"To evaluate the efficacy and safety of SHR-4597 inhalants in adults with asthma: a multicenter, randomized, open-label, positive-controlled Phase II clinical study",[424],"2025-04-16",{"date":465,"type":32},"2025-04-23",{"date":467,"type":21},"2025-04",{"date":450,"type":21},{"name":38,"class":39},""]