A Study of TJ003234 in Rheumatoid Arthritis Patients

NCT04457856 | Unknown Phase 1

• 1 other identifier: TJ003234RAR102
• Study Type: interventional
• Target: 63
• Locations: 1 country
• Sites: 5

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.

Conditions

Rheumatoid Arthritis

Keywords

Rheumatoid Arthritis; biologics

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• 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

  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

  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

  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

  Day1 to 90 days after dosing for single dose part, 140 days after for multiple dose part

Study Arms (2)

TJ003234

EXPERIMENTAL

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

Placebo

PLACEBO COMPARATOR

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

Interventions

TJ003234 injection BIOLOGICAL

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

Placebo; TJ003234

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• I-Mab Biopharma US Limited: lead

Study Sites (5)

The first affiliated hospital of bengbu medical college

Bengbu, Anhui, China

RECRUITING

Peking university people's Hospital

Beijing, Beijing Municipality, 10044, China

RECRUITING

Nanjing Drum Tower Hospital

Nanjing, Jiangsu, China

RECRUITING

Zhongda Hospital southeast university

Nanjing, Jiangsu, China

RECRUITING

FuDan University shanghai huashan Hospital

Shanghai, Shanghai Municipality, China

RECRUITING

MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

plonmarlimab

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Central Study Contacts

Zhanguo Li

CONTACT

+86010-88326666; li99@bjmu.edu.cn

yingchao Zhou

CONTACT

+86010-56176269; yingchao.zhou@i-mabbiopharma.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Double-blind
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Randomized, Double-blind, Placebo-controlled

Study Record Dates

• First Submitted: June 28, 2020
• First Posted: July 7, 2020
• Study Start: August 6, 2020
• Primary Completion: March 1, 2023
• Study Completion: March 1, 2023
• Last Updated: August 3, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (5)