Ignite Creation Date:
2025-12-24 @ 11:16 PM
Ignite Modification Date:
2025-12-25 @ 8:53 PM
Study NCT ID:
NCT04457856
Status:
UNKNOWN
Last Update Posted:
2022-08-03
First Post:
2020-06-28
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Study of TJ003234 in Rheumatoid Arthritis Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001172', 'term': 'Arthritis, Rheumatoid'}], 'ancestors': [{'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}, {'id': 'D003240', 'term': 'Connective Tissue Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000711830', 'term': 'plonmarlimab'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT'], 'maskingDescription': 'Double-blind'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Randomized, Double-blind, Placebo-controlled'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 63}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-08-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-08', 'completionDateStruct': {'date': '2023-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-08-02', 'studyFirstSubmitDate': '2020-06-28', 'studyFirstSubmitQcDate': '2020-06-30', 'lastUpdatePostDateStruct': {'date': '2022-08-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-07-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of subject with adverse events(AEs)', 'timeFrame': 'First dose up to last follow-up visit (i.e. 90 days after dosing for single dose part, 140 days after first dose for multiple dose part)', 'description': 'Number of subject with adverse events(AEs) to evaluate satety in patient with RA with vital signs, Electrocardiograms, physical examinations, laboratory tests and respiratory-related examinations'}], 'secondaryOutcomes': [{'measure': 'AUC from time 0 to the time of the last quantifiable concentration AUC0-tlast of TJ003234', 'timeFrame': 'Day1 to 90 days after dosing for single dose part, 140 days after for multiple dose part', 'description': 'AUC from time 0 to the time of the last quantifiable concentration AUC0-tlast of TJ003234'}, {'measure': 'Maximum observed plasma concentration (Cmax) of TJ003234', 'timeFrame': 'Day1 to 90 days after dosing for single dose part, 140 days after for multiple dose part', 'description': 'Maximum observed plasma concentration (Cmax) of TJ003234'}, {'measure': 'The proportion of subjects who produce anti-drug antibodies', 'timeFrame': 'Day1 to 90 days after dosing for single dose part, 140 days after for multiple dose part', 'description': 'The proportion of subjects who produce anti-drug antibodies'}, {'measure': 'The proportion of subjects who produce neutralizing antibodies', 'timeFrame': 'Day1 to 90 days after dosing for single dose part, 140 days after for multiple dose part', 'description': 'The proportion of subjects who produce neutralizing antibodies'}, {'measure': 'The proportion of subjects who produce the titers of anti-drug antibodies and neutralizing antibodies', 'timeFrame': 'Day1 to 90 days after dosing for single dose part, 140 days after for multiple dose part', 'description': 'The proportion of subjects who produce the titers of anti-drug antibodies and neutralizing antibodies'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Rheumatoid Arthritis', 'biologics'], 'conditions': ['Rheumatoid Arthritis']}, 'descriptionModule': {'briefSummary': 'Study Purpose and Design: A Multi-center, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Single Ascending Dose and Multiple Ascending Doses of TJ003234 in Rheumatoid Arthritis Patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Subjects must be ≥ 18 and ≤70 years old when signing the informed consent, with no limitation of gender.\n* Established Rheumatoid arthritis patients, diagnosed by ACR/EULAR criteria 2010 at least 6 months prior to randomisation.\n* Single Ascending Dose: DAS28 score≤3.2. Multiple Ascending Dose: DAS28 score≤5.1 and \\>3.2.\n* Allowed one or more standard treatments, but the start date should no later than 12 weeks(84 days) before the randomisation and should take at a stable dose more than 4 weeks(28 days) before the randomisation. The combination taken of Methotrexate (MTX) and leflunomide was not allowed within 4 weeks (28 days) before randomization.\n* Subjects must agree to attendance the study and signed the inform concent by themselves.\n* Subjects(include subjects's wife) are no pregnancy plan during the sceering and 3 months after complete the study and agree to use contraceptives that protocol suggest.\n\nExclusion Criteria:\n\n* Employees of the hospital or any other person that paticipant in the study and their immedidte family members.\n* A documented history of an autoimmune disease other than RA (other than secondary Sjögren's syndrome) .\n* Previous received Any biologic DMARD therapy including tsDMARD. •A positive hepatitis B (HBsAg, anti-HBc, and/or IgM anti-HBc), hepatitis C or HIV test at screening, indicative of a current or past infection.\n* A history of active tuberculosis (TB) or positive serological test for TB (Quantiferon TB Gold or T-SPOT).\n* Female patients who are pregnant during the study, or are breastfeeding. •Malignancy, or prior malignancy, with a disease free interval of \\<5 years after diagnosis and intervention except curative treatment for basal and squamous cell skin cancer."}, 'identificationModule': {'nctId': 'NCT04457856', 'briefTitle': 'A Study of TJ003234 in Rheumatoid Arthritis Patients', 'organization': {'class': 'INDUSTRY', 'fullName': 'I-Mab Biopharma US Limited'}, 'officialTitle': 'A Multi-center, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Single Ascending Dose and Multiple Ascending Doses of TJ003234 in Rheumatoid Arthritis Patients', 'orgStudyIdInfo': {'id': 'TJ003234RAR102'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'TJ003234', 'description': 'Intravenous administration, single dose (0.3-1-3-10mg/kg) or multiple dose (1-3-6mg/kg, once every week, for 8 weeks) Mode of administration: The investigational drug is administered by intravenous infusion', 'interventionNames': ['Biological: TJ003234 injection']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Intravenous administration, single dose (0.3-1-3-10mg/kg) or multiple dose (1-3-6mg/kg, once every week, for 8 weeks) Mode of administration: The investigational drug is administered by intravenous infusion', 'interventionNames': ['Biological: TJ003234 injection']}], 'interventions': [{'name': 'TJ003234 injection', 'type': 'BIOLOGICAL', 'description': 'Intravenous administration, single dose (0.3-1-3-10mg/kg) or multiple dose (1-3-6mg/kg, once every week, for 8 weeks)', 'armGroupLabels': ['Placebo', 'TJ003234']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Bengbu', 'state': 'Anhui', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Zhijun Li', 'role': 'CONTACT', 'email': 'lizhijundr@126.com', 'phone': '13955289810'}], 'facility': 'The first affiliated hospital of bengbu medical college', 'geoPoint': {'lat': 32.94083, 'lon': 117.36083}}, {'zip': '10044', 'city': 'Beijing', 'state': 'Beijing Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Zhanguo Li', 'role': 'CONTACT', 'email': 'li99@bjmu.edu.cn', 'phone': '+86010-88326666'}], 'facility': "Peking university people's Hospital", 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'city': 'Nanjing', 'state': 'Jiangsu', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Lingyun Sun', 'role': 'CONTACT', 'email': 'lingyunsun2012@163.com', 'phone': '13705186409'}], 'facility': 'Nanjing Drum Tower Hospital', 'geoPoint': {'lat': 32.06167, 'lon': 118.77778}}, {'city': 'Nanjing', 'state': 'Jiangsu', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Meimei Wang', 'role': 'CONTACT', 'email': 'wmm3272142@163.com', 'phone': '13505167748'}], 'facility': 'Zhongda Hospital southeast university', 'geoPoint': {'lat': 32.06167, 'lon': 118.77778}}, {'city': 'Shanghai', 'state': 'Shanghai Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Yu Xue', 'role': 'CONTACT', 'email': '18121186087@163.com', 'phone': '18918760187'}], 'facility': 'FuDan University shanghai huashan Hospital', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'centralContacts': [{'name': 'Zhanguo Li', 'role': 'CONTACT', 'email': 'li99@bjmu.edu.cn', 'phone': '+86010-88326666'}, {'name': 'yingchao Zhou', 'role': 'CONTACT', 'email': 'yingchao.zhou@i-mabbiopharma.com', 'phone': '+86010-56176269'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'I-Mab Biopharma US Limited', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}