[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100620003":3},{"organization":4,"outcomesModule":7,"designInfo":38,"detailedDescription":11,"studyPopulation":11,"armGroups":50,"interventions":74,"overallOfficials":11,"centralContacts":92,"locations":98,"responsibleParty":120,"collaborators":11,"id":122,"slug":11,"hasResults":123,"nctId":124,"briefTitle":125,"officialTitle":126,"acronym":11,"eligibilityCriteria":127,"healthyVolunteers":123,"sex":128,"minAge":129,"maxAge":130,"enrollmentInfo":131,"targetDuration":11,"studyType":134,"phases":135,"briefSummary":137,"conditions":138,"keywords":11,"overallStatus":101,"whyStopped":11,"lastUpdateSubmitDate":141,"lastUpdatePostDateStruct":142,"startDateStruct":145,"completionDateStruct":147,"leadSponsor":149,"locationsCount":150},{"fullName":5,"class":6},"Shandong Suncadia Medicine Co., Ltd.","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":11},[9],{"measure":10,"description":11,"timeFrame":12},"Change from baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain subscale scores.",null,"At week 4.",[14,16,19,21,23,25,27,29,32,36],{"measure":10,"description":11,"timeFrame":15},"From baseline to Week 1, 2 and 3.",{"measure":17,"description":11,"timeFrame":18},"Change from baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) joint function subscale scores.","From baseline to Week 1, 2, 3 and 4.",{"measure":20,"description":11,"timeFrame":18},"Change from baseline in the weekly mean (Week 1, 2, 3 and 4) of the index Knee Numerical Rating Scale (NRS) pain score (resting).",{"measure":22,"description":11,"timeFrame":18},"Change from baseline in the weekly mean (Week 1, 2, 3 and 4) of the index Knee Numerical Rating Scale (NRS) pain score (flat walking).",{"measure":24,"description":11,"timeFrame":18},"Change from baseline in the overall patient global assessment (PGA) of osteoarthritis condition using the 5-point Likert scale.",{"measure":26,"description":11,"timeFrame":18},"Change from baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) stiffness subscale scores.",{"measure":28,"description":11,"timeFrame":18},"Change from baseline in total Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) score.",{"measure":30,"description":11,"timeFrame":31},"Treatment response: WOMAC pain subscale scores decreased by ≥ 30%, ≥ 50%, ≥ 70% from baseline.","At Week 1, 2, 3 and 4.",{"measure":33,"description":34,"timeFrame":35},"Adverse events (AEs) occurred during the study.","To evaluate the safety and tolerability of HRS-2129 tablets.","During the study, approximately 8 months.",{"measure":37,"description":34,"timeFrame":35},"Serious adverse events (SAEs) occurred during the study.",{"allocation":39,"interventionModel":40,"interventionModelDescription":41,"primaryPurpose":42,"observationalModel":11,"timePerspective":11,"maskingInfo":43},"RANDOMIZED","PARALLEL","Comparison between HRS-2129 high dose group, HRS-2129 low dose group, Celecoxib positive control group, and Placebo control group.","TREATMENT",{"masking":44,"maskingDescription":11,"whoMasked":45},"QUADRUPLE",[46,47,48,49],"PARTICIPANT","CARE_PROVIDER","INVESTIGATOR","OUTCOMES_ASSESSOR",[51,59,63,69],{"label":52,"type":53,"description":54,"interventionNames":55},"HRS-2129 High Dose Group","EXPERIMENTAL","HRS-2129 high dose group.",[56,57,58],"Drug: HRS-2129 Tablet","Drug: Celecoxib Capsule Placebo","Drug: HRS-2129 Tablet Placebo",{"label":60,"type":53,"description":61,"interventionNames":62},"HRS-2129 Low Dose Group","HRS-2129 low dose group.",[56,57,58],{"label":64,"type":65,"description":66,"interventionNames":67},"Celecoxib Group","ACTIVE_COMPARATOR","Celecoxib group.",[68,58],"Drug: Celecoxib capsule",{"label":70,"type":71,"description":72,"interventionNames":73},"Placebo Group","PLACEBO_COMPARATOR","Placebo group.",[57,58],[75,80,84,88],{"type":76,"name":77,"description":78,"armGroupLabels":79,"otherNames":11},"DRUG","HRS-2129 Tablet","HRS-2129 tablet.",[52,60],{"type":76,"name":81,"description":82,"armGroupLabels":83,"otherNames":11},"Celecoxib capsule","Celecoxib capsule.",[64],{"type":76,"name":85,"description":86,"armGroupLabels":87,"otherNames":11},"Celecoxib Capsule Placebo","Celecoxib capsule placebo.",[52,60,70],{"type":76,"name":89,"description":90,"armGroupLabels":91,"otherNames":11},"HRS-2129 Tablet Placebo","HRS-2129 tablet placebo.",[64,52,60,70],[93],{"name":94,"role":95,"phone":96,"phoneExt":11,"email":97},"Zhuang Nie","CONTACT","+86-0518-82342973","zhuang.nie@hengrui.com",[99],{"facility":100,"status":101,"city":102,"state":103,"zip":104,"country":105,"countryCode":106,"cosmosGeoPoint":107,"geoPoint":112,"contacts":113},"Drum Tower Hospital affiliated to Nanjing University School of Medicine","RECRUITING","Nanjing","Jiangsu","210005","China","CN",{"type":108,"coordinates":109},"Point",[110,111],118.77778,32.06167,{"lat":111,"lon":110},[114,118],{"name":115,"role":95,"phone":116,"phoneExt":11,"email":117},"Qing Jiang","+86-025-83106666","jiangqing112@hotmail.com",{"name":115,"role":119,"phone":11,"phoneExt":11,"email":11},"PRINCIPAL_INVESTIGATOR",{"type":121,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","100620003",false,"NCT07351968","A Phase Ib Study to Evaluate the Efficacy and Safety of HRS-2129 in Patients With Knee Osteoarthritis","A Multicenter, Randomized, Double-blind, Agent-positive and Placebo-controlled, Parallel-group Phase Ib Study to Evaluate the Efficacy and Safety of HRS-2129 in Patients With Knee Osteoarthritis","Inclusion Criteria:\n\n1. Voluntarily sign the informed consent form before starting the activities related to the trial;\n2. The Numerical Evaluation Scale (NRS) pain score of the index knee joint at screening is ≥ 4;\n3. Subjects must be willing to discontinue all medical and non-medical treatments for osteoarthritis pain except rescue medication (acetaminophen) and not use prohibited analgesics throughout the study ;\n4. Male and female subjects of childbearing potential must agree to use highly effective contraceptive measures with their partners from the signing of the informed consent form until 1 month after the last dose of investigational product.\n\nExclusion Criteria:\n\n1. History of other diseases that may involve the target joint;\n2. History of major trauma or surgery of knee joint and hip joint in the past year;\n3. Plan to undergo surgical procedure during the study;\n4. Most or complete loss of mobility;\n5. There are other diseases that may confuse the assessment of osteoarthritis pain;\n6. There is a neuropsychiatric disease, and the investigator's assessment may affect the evaluation of osteoarthritis (OA) or self-score;\n7. There are serious or poorly controlled concomitant diseases;\n8. Those who have a clear history of peptic ulcer, bleeding, perforation or obstruction within 1 year before screening, and have been clinically diagnosed;\n9. Those who require drug treatment or surgical intervention;\n10. History of malignant tumors within 5 years before screening;\n11. Have a history of drug abuse, drug abuse and\u002For alcoholism within 2 years before screening.","ALL","18 Years","80 Years",{"count":132,"type":133},200,"ESTIMATED","INTERVENTIONAL",[136],"PHASE1","Primary Objective: To explore the effectiveness of different doses of HRS-2129 in the treatment of patients with moderate to severe pain in knee osteoarthritis. Secondary Objectives: To evaluate the safety of different doses of HRS-2129 for the treatment of patients with moderate to severe pain in knee osteoarthritis; To evaluate the population pharmacokinetic profile of HRS-2129 in patients with knee osteoarthritis.",[139,140],"Moderate Pain in Knee Osteoarthritis","Severe Pain in Knee Osteoarthritis","2026-03-18",{"date":143,"type":144},"2026-03-19","ACTUAL",{"date":146,"type":144},"2026-03-10",{"date":148,"type":133},"2026-08",{"name":5,"class":6},1]