Back to resultsA Study of TJ003234 in Rheumatoid Arthritis Patients
Primary Purpose
Rheumatoid Arthritis
Status
Recruiting
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
TJ003234 injection
Sponsored by
About this trial
This is an interventional treatment trial for Rheumatoid Arthritis focused on measuring Rheumatoid Arthritis, biologics
Eligibility Criteria
Inclusion Criteria:
- Subjects must be ≥ 18 and ≤70 years old when signing the informed consent, with no limitation of gender.
- Established Rheumatoid arthritis patients, diagnosed by ACR/EULAR criteria 2010 at least 6 months prior to randomisation.
- Single Ascending Dose: DAS28 score≤3.2. Multiple Ascending Dose: DAS28 score≤5.1 and >3.2.
- 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.
- Subjects must agree to attendance the study and signed the inform concent by themselves.
- 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.
Exclusion Criteria:
- Employees of the hospital or any other person that paticipant in the study and their immedidte family members.
- A documented history of an autoimmune disease other than RA (other than secondary Sjögren's syndrome) .
- 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.
- A history of active tuberculosis (TB) or positive serological test for TB (Quantiferon TB Gold or T-SPOT).
- 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.
Sites / Locations
- The first affiliated hospital of bengbu medical collegeRecruiting
- Peking university people's HospitalRecruiting
- Nanjing Drum Tower HospitalRecruiting
- Zhongda Hospital southeast universityRecruiting
- FuDan University shanghai huashan HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
TJ003234
Placebo
Arm 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
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
Outcomes
Primary Outcome Measures
Number of subject with adverse events(AEs)
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
Secondary Outcome Measures
AUC from time 0 to the time of the last quantifiable concentration AUC0-tlast of TJ003234
AUC from time 0 to the time of the last quantifiable concentration AUC0-tlast of TJ003234
Maximum observed plasma concentration (Cmax) of TJ003234
Maximum observed plasma concentration (Cmax) of TJ003234
The proportion of subjects who produce anti-drug antibodies
The proportion of subjects who produce anti-drug antibodies
The proportion of subjects who produce neutralizing antibodies
The proportion of subjects who produce neutralizing antibodies
The proportion of subjects who produce the titers of anti-drug antibodies and neutralizing antibodies
The proportion of subjects who produce the titers of anti-drug antibodies and neutralizing antibodies
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04457856
Brief Title
A Study of TJ003234 in Rheumatoid Arthritis Patients
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
August 2022
Overall Recruitment Status
Recruiting
Study Start Date
August 6, 2020 (Actual)
Primary Completion Date
March 2023 (Anticipated)
Study Completion Date
March 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
I-Mab Biopharma Co. Ltd.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rheumatoid Arthritis
Keywords
Rheumatoid Arthritis, biologics
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Model Description
Randomized, Double-blind, Placebo-controlled
Masking
Participant
Masking Description
Double-blind
Allocation
Randomized
Enrollment
63 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
TJ003234
Arm Type
Experimental
Arm 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
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm 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
Intervention Type
Biological
Intervention Name(s)
TJ003234 injection
Intervention Description
Intravenous administration, single dose (0.3-1-3-10mg/kg) or multiple dose (1-3-6mg/kg, once every week, for 8 weeks)
Primary Outcome Measure Information:
Title
Number of subject with adverse events(AEs)
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
Time Frame
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)
Secondary Outcome Measure Information:
Title
AUC from time 0 to the time of the last quantifiable concentration AUC0-tlast of TJ003234
Description
AUC from time 0 to the time of the last quantifiable concentration AUC0-tlast of TJ003234
Time Frame
Day1 to 90 days after dosing for single dose part, 140 days after for multiple dose part
Title
Maximum observed plasma concentration (Cmax) of TJ003234
Description
Maximum observed plasma concentration (Cmax) of TJ003234
Time Frame
Day1 to 90 days after dosing for single dose part, 140 days after for multiple dose part
Title
The proportion of subjects who produce anti-drug antibodies
Description
The proportion of subjects who produce anti-drug antibodies
Time Frame
Day1 to 90 days after dosing for single dose part, 140 days after for multiple dose part
Title
The proportion of subjects who produce neutralizing antibodies
Description
The proportion of subjects who produce neutralizing antibodies
Time Frame
Day1 to 90 days after dosing for single dose part, 140 days after for multiple dose part
Title
The proportion of subjects who produce the titers of anti-drug antibodies and neutralizing antibodies
Description
The proportion of subjects who produce the titers of anti-drug antibodies and neutralizing antibodies
Time Frame
Day1 to 90 days after dosing for single dose part, 140 days after for multiple dose part
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Subjects must be ≥ 18 and ≤70 years old when signing the informed consent, with no limitation of gender.
Established Rheumatoid arthritis patients, diagnosed by ACR/EULAR criteria 2010 at least 6 months prior to randomisation.
Single Ascending Dose: DAS28 score≤3.2. Multiple Ascending Dose: DAS28 score≤5.1 and >3.2.
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.
Subjects must agree to attendance the study and signed the inform concent by themselves.
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.
Exclusion Criteria:
Employees of the hospital or any other person that paticipant in the study and their immedidte family members.
A documented history of an autoimmune disease other than RA (other than secondary Sjögren's syndrome) .
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.
A history of active tuberculosis (TB) or positive serological test for TB (Quantiferon TB Gold or T-SPOT).
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Zhanguo Li
Phone
+86010-88326666
Email
li99@bjmu.edu.cn
First Name & Middle Initial & Last Name or Official Title & Degree
yingchao Zhou
Phone
+86010-56176269
Email
yingchao.zhou@i-mabbiopharma.com
Facility Information:
Facility Name
The first affiliated hospital of bengbu medical college
City
Bengbu
State/Province
Anhui
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zhijun Li
Phone
13955289810
Email
lizhijundr@126.com
Facility Name
Peking university people's Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
10044
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zhanguo Li
Phone
+86010-88326666
Email
li99@bjmu.edu.cn
Facility Name
Nanjing Drum Tower Hospital
City
Nanjing
State/Province
Jiangsu
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lingyun Sun
Phone
13705186409
Email
lingyunsun2012@163.com
Facility Name
Zhongda Hospital southeast university
City
Nanjing
State/Province
Jiangsu
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Meimei Wang
Phone
13505167748
Email
wmm3272142@163.com
Facility Name
FuDan University shanghai huashan Hospital
City
Shanghai
State/Province
Shanghai
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yu Xue
Phone
18918760187
Email
18121186087@163.com
12. IPD Sharing Statement
Plan to Share IPD
No
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A Study of TJ003234 in Rheumatoid Arthritis Patients
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