A Study of TJ003234 in Rheumatoid Arthritis Patients

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 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.

Study Overview

• Status: Recruiting
• Conditions: Rheumatoid Arthritis
• Intervention / Treatment: Biological: TJ003234 injection

• Study Type: Interventional
• Enrollment (Anticipated): 63
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Zhanguo Li; Phone Number: +86010-88326666; Email: li99@bjmu.edu.cn
• Study Contact Backup: Name: yingchao Zhou; Phone Number: +86010-56176269; Email: yingchao.zhou@i-mabbiopharma.com

Study Locations

• China
  • Anhui
    • Bengbu, Anhui, China
      • Recruiting
      • The First Affiliated Hospital of Bengbu Medical College
      • Contact: Zhijun Li; Phone Number: 13955289810; Email: lizhijundr@126.com
  • Beijing
    • Beijing, Beijing, China, 10044
      • Recruiting
      • Peking University People's Hospital
      • Contact: Zhanguo Li; Phone Number: +86010-88326666; Email: li99@bjmu.edu.cn
  • Jiangsu
    • Nanjing, Jiangsu, China
      • Recruiting
      • Zhongda Hospital Southeast University
      • Contact: Meimei Wang; Phone Number: 13505167748; Email: wmm3272142@163.com
    • Nanjing, Jiangsu, China
      • Recruiting
      • Nanjing Drum Tower Hospital
      • Contact: Lingyun Sun; Phone Number: 13705186409; Email: lingyunsun2012@163.com
  • Shanghai
    • Shanghai, Shanghai, China
      • Recruiting
      • FuDan University shanghai huashan Hospital
      • Contact: Yu Xue; Phone Number: 18918760187; Email: 18121186087@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: TJ003234; 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	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)
PLACEBO_COMPARATOR: Placebo; 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	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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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

Collaborators and Investigators

• Sponsor: I-Mab Biopharma Co. Ltd.

Study record dates

Study Major Dates

• Study Start (ACTUAL): August 6, 2020
• Primary Completion (ANTICIPATED): March 1, 2023
• Study Completion (ANTICIPATED): March 1, 2023

Study Registration Dates

• First Submitted: June 28, 2020
• First Submitted That Met QC Criteria: June 30, 2020
• First Posted (ACTUAL): July 7, 2020

Study Record Updates

• Last Update Posted (ACTUAL): August 3, 2022
• Last Update Submitted That Met QC Criteria: August 2, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Keywords: Rheumatoid Arthritis; biologics
• Additional Relevant MeSH Terms: Immune System Diseases; Autoimmune Diseases; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Arthritis; Arthritis, Rheumatoid; Anti-Infective Agents; Antiviral Agents; Anti-Inflammatory Agents; Plonmarlimab
• Other Study ID Numbers: TJ003234RAR102

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No