Ignite Creation Date:
2026-03-26 @ 3:15 PM
Ignite Modification Date:
2026-03-30 @ 2:22 AM
Study NCT ID:
NCT07351968
Status:
RECRUITING
Last Update Posted:
2026-03-19
First Post:
2026-01-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Phase Ib Study to Evaluate the Efficacy and Safety of HRS-2129 in Patients With Knee Osteoarthritis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000068579', 'term': 'Celecoxib'}], 'ancestors': [{'id': 'D000096926', 'term': 'Benzenesulfonamides'}, {'id': 'D013449', 'term': 'Sulfonamides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D013450', 'term': 'Sulfones'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D011720', 'term': 'Pyrazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Comparison between HRS-2129 high dose group, HRS-2129 low dose group, Celecoxib positive control group, and Placebo control group.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2026-03-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-03', 'completionDateStruct': {'date': '2026-08', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-03-18', 'studyFirstSubmitDate': '2026-01-11', 'studyFirstSubmitQcDate': '2026-01-11', 'lastUpdatePostDateStruct': {'date': '2026-03-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-01-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-08', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change from baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain subscale scores.', 'timeFrame': 'At week 4.'}], 'secondaryOutcomes': [{'measure': 'Change from baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain subscale scores.', 'timeFrame': 'From baseline to Week 1, 2 and 3.'}, {'measure': 'Change from baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) joint function subscale scores.', 'timeFrame': 'From baseline to Week 1, 2, 3 and 4.'}, {'measure': 'Change from baseline in the weekly mean (Week 1, 2, 3 and 4) of the index Knee Numerical Rating Scale (NRS) pain score (resting).', 'timeFrame': 'From baseline to Week 1, 2, 3 and 4.'}, {'measure': '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).', 'timeFrame': 'From baseline to Week 1, 2, 3 and 4.'}, {'measure': 'Change from baseline in the overall patient global assessment (PGA) of osteoarthritis condition using the 5-point Likert scale.', 'timeFrame': 'From baseline to Week 1, 2, 3 and 4.'}, {'measure': 'Change from baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) stiffness subscale scores.', 'timeFrame': 'From baseline to Week 1, 2, 3 and 4.'}, {'measure': 'Change from baseline in total Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) score.', 'timeFrame': 'From baseline to Week 1, 2, 3 and 4.'}, {'measure': 'Treatment response: WOMAC pain subscale scores decreased by ≥ 30%, ≥ 50%, ≥ 70% from baseline.', 'timeFrame': 'At Week 1, 2, 3 and 4.'}, {'measure': 'Adverse events (AEs) occurred during the study.', 'timeFrame': 'During the study, approximately 8 months.', 'description': 'To evaluate the safety and tolerability of HRS-2129 tablets.'}, {'measure': 'Serious adverse events (SAEs) occurred during the study.', 'timeFrame': 'During the study, approximately 8 months.', 'description': 'To evaluate the safety and tolerability of HRS-2129 tablets.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Moderate Pain in Knee Osteoarthritis', 'Severe Pain in Knee Osteoarthritis']}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "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/or alcoholism within 2 years before screening."}, 'identificationModule': {'nctId': 'NCT07351968', 'briefTitle': 'A Phase Ib Study to Evaluate the Efficacy and Safety of HRS-2129 in Patients With Knee Osteoarthritis', 'organization': {'class': 'INDUSTRY', 'fullName': 'Shandong Suncadia Medicine Co., Ltd.'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': 'HRS-2129-106'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'HRS-2129 High Dose Group', 'description': 'HRS-2129 high dose group.', 'interventionNames': ['Drug: HRS-2129 Tablet', 'Drug: Celecoxib Capsule Placebo', 'Drug: HRS-2129 Tablet Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'HRS-2129 Low Dose Group', 'description': 'HRS-2129 low dose group.', 'interventionNames': ['Drug: HRS-2129 Tablet', 'Drug: Celecoxib Capsule Placebo', 'Drug: HRS-2129 Tablet Placebo']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Celecoxib Group', 'description': 'Celecoxib group.', 'interventionNames': ['Drug: Celecoxib capsule', 'Drug: HRS-2129 Tablet Placebo']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo Group', 'description': 'Placebo group.', 'interventionNames': ['Drug: Celecoxib Capsule Placebo', 'Drug: HRS-2129 Tablet Placebo']}], 'interventions': [{'name': 'HRS-2129 Tablet', 'type': 'DRUG', 'description': 'HRS-2129 tablet.', 'armGroupLabels': ['HRS-2129 High Dose Group', 'HRS-2129 Low Dose Group']}, {'name': 'Celecoxib capsule', 'type': 'DRUG', 'description': 'Celecoxib capsule.', 'armGroupLabels': ['Celecoxib Group']}, {'name': 'Celecoxib Capsule Placebo', 'type': 'DRUG', 'description': 'Celecoxib capsule placebo.', 'armGroupLabels': ['HRS-2129 High Dose Group', 'HRS-2129 Low Dose Group', 'Placebo Group']}, {'name': 'HRS-2129 Tablet Placebo', 'type': 'DRUG', 'description': 'HRS-2129 tablet placebo.', 'armGroupLabels': ['Celecoxib Group', 'HRS-2129 High Dose Group', 'HRS-2129 Low Dose Group', 'Placebo Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '210005', 'city': 'Nanjing', 'state': 'Jiangsu', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Qing Jiang', 'role': 'CONTACT', 'email': 'jiangqing112@hotmail.com', 'phone': '+86-025-83106666'}, {'name': 'Qing Jiang', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Drum Tower Hospital affiliated to Nanjing University School of Medicine', 'geoPoint': {'lat': 32.06167, 'lon': 118.77778}}], 'centralContacts': [{'name': 'Zhuang Nie', 'role': 'CONTACT', 'email': 'zhuang.nie@hengrui.com', 'phone': '+86-0518-82342973'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shandong Suncadia Medicine Co., Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}