A Study of TJ003234 in Rheumatoid Arthritis Patients

I-Mab Biopharma

Status and phase: Enrolling; Phase 1

Conditions: Rheumatoid Arthritis

Treatments: Biological: TJ003234 injection

Study type: Interventional

Funder types: Industry

Identifiers

NCT04457856

TJ003234RAR102

Details and patient eligibility

About

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.

Enrollment: 63 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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63 participants in 2 patient groups, including a placebo group

TJ003234

Experimental group

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

Treatment:

Biological: TJ003234 injection

Placebo

Placebo Comparator group

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

Treatment:

Biological: TJ003234 injection