A Study of TJ003234 in Rheumatoid Arthritis Patients

Rheumatoid Arthritis Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04457856
• Other study ID #: TJ003234RAR102
• Status: Recruiting
• Phase: Phase 1
• Start date: August 6, 2020
• Est. completion date: March 2023

Study information

• Verified date: August 2022
• Source: I-Mab Biopharma Co. Ltd.
• Contact: Zhanguo Li
• Phone: +86010-88326666
• Email: li99[@]bjmu.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 63
• Est. completion date: March 2023
• Est. primary completion date: March 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis

Intervention

Biological:
• TJ003234 injection
Intravenous administration, single dose (0.3-1-3-10mg/kg) or multiple dose (1-3-6mg/kg, once every week, for 8 weeks)

Locations

Country	Name	City	State
China	Peking university people's Hospital	Beijing	Beijing
China	The first affiliated hospital of bengbu medical college	Bengbu	Anhui
China	Nanjing Drum Tower Hospital	Nanjing	Jiangsu
China	Zhongda Hospital southeast university	Nanjing	Jiangsu
China	FuDan University shanghai huashan Hospital	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
I-Mab Biopharma Co. Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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	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	Day1 to 90 days after dosing for single dose part, 140 days after for multiple dose part
Secondary	Maximum observed plasma concentration (Cmax) of TJ003234	Maximum observed plasma concentration (Cmax) of TJ003234	Day1 to 90 days after dosing for single dose part, 140 days after for multiple dose part
Secondary	The proportion of subjects who produce anti-drug antibodies	The proportion of subjects who produce anti-drug antibodies	Day1 to 90 days after dosing for single dose part, 140 days after for multiple dose part
Secondary	The proportion of subjects who produce neutralizing antibodies	The proportion of subjects who produce neutralizing antibodies	Day1 to 90 days after dosing for single dose part, 140 days after for multiple dose part
Secondary	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	Day1 to 90 days after dosing for single dose part, 140 days after for multiple dose part