Phase II Trial of VDJ001 in Patients With Moderate-to-severe Active Rheumatoid Arthritis

NCT05957107 | Completed Phase 2

• 1 other identifier: VDJ001-RA-II
• Study Type: interventional
• Target: 181
• Locations: 1 country
• Sites: 15

Brief Summary

This is a multicenter, randomized, double-blind, placebo and tocilizumab controlled phase II trial in RA patients to evaluate the initial efficacy, safety, pharmacokinetic, pharmacodynamic characteristics, and immunogenicity of VDJ001 in RA patients.

Conditions

Rheumatoid Arthritis

Outcome Measures

Primary Outcomes (1)

• Proportion of patients who achieved ACR20 at week 12.

  Proportion of patients who achieved American College of Rheumatology 20% improvement criteria (ACR20) at week 12.

  12 weeks

Secondary Outcomes (10)

• Proportion of patients who achieved ACR50, ACR70 at week 12.

  12 weeks

• Proportion of patients who achieved DAS28-CRP <2.6, DAS28-ESR <2.6, DAS28-CRP <3.2, DAS28-ESR <3.2 at week 12.

  12 weeks

• Proportion of patients who achieved a good response rate on the Clinical Disease Activity Index (CDAI) (defined as ≥50% improvement in CDAI or CDAI ≤2.8) at Week 12.

  12 weeks

• Change in duration of morning stiffness at week 12 relative to baseline and rate of change.

  12 weeks

• Patient ratings of arthralgia

  12 weeks

Study Arms (4)

Injection of recombinant humanized monoclonal antibody against interleukin-6 receptor 4 mg/kg

EXPERIMENTAL

Recombinant Humanized Anti-interleukin-6 Receptor Monoclonal Antibody Injection 4 mg/kg as the low dose group.

Biological: Recombinant Humanized Anti-interleukin-6 Receptor Monoclonal Antibody Injection

Injection of recombinant humanized monoclonal antibody against interleukin-6 receptor6mg/kg

EXPERIMENTAL

Recombinant Humanized Anti-interleukin-6 Receptor Monoclonal Antibody Injection 6mg/kg as the middle dose group.

Biological: Recombinant Humanized Anti-interleukin-6 Receptor Monoclonal Antibody Injection

placebo control

EXPERIMENTAL

placebo control

Biological: Recombinant Humanized Anti-interleukin-6 Receptor Monoclonal Antibody Injection

Tocilizumab Injection8mg/kg

EXPERIMENTAL

Tocilizumab Injection8mg/kg

Biological: Recombinant Humanized Anti-interleukin-6 Receptor Monoclonal Antibody Injection

Interventions

Recombinant Humanized Anti-interleukin-6 Receptor Monoclonal Antibody Injection BIOLOGICAL

The drug was administered once every 4 weeks.

Also known as: Tocilizumab Injection, placebo control

Injection of recombinant humanized monoclonal antibody against interleukin-6 receptor 4 mg/kg; Injection of recombinant humanized monoclonal antibody against interleukin-6 receptor6mg/kg; Tocilizumab Injection8mg/kg; placebo control

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects must meet all of the following criteria to be included:
• Voluntarily sign the informed consent;
• Age 18-75 years old (including boundary values);
• RA was diagnosed according to the 1987 American College of Rheumatology (ACR) criteria or the 2010 ACR and EULAR classification criteria;
• Moderate to severe active RA was determined according to the following criteria: the number of joint swelling ≥6 (based on 66 joints) and the number of joint tenderness ≥6 (based on 68 joints), and the C-reactive protein (CRP) ≥10 mg/L or erythrocyte sedimentation rate (ESR) ≥28 mm/h;
• Had received oral methotrexate (MTX) therapy for at least 12 weeks with a stable dose (MTX dose of 7.5-25 mg/ week) for at least 4 weeks before randomization; Subjects with a history of parenteral MTX use (subcutaneous, intramuscular, or intravenous) were eligible, but they had to have received a stable dose of MTX 7.5 to 25mg/ week orally for ≥4 weeks before randomization;
• If subjects were taking prednisone or equivalent glucocorticoids at the time of screening, they were treated with a stable dose (prednisone dose ≤10mg/ day) for at least 4 weeks before randomization.

You may not qualify if:

• Participants who meet any of the following conditions will not be included in the study:
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• Weight \>100 kg or \<40 kg.
• Patients with ACR function grade IV or long-term bedridden/wheelchair-bound.
• Persons with allergies or known allergies to any of the ingredients and/or other similar products under study.
• The investigator determined that the subject had undergone or planned surgery that might affect the study evaluation of the evaluated joint.
• Patients with rheumatic immune diseases other than rheumatoid arthritis, uncontrolled immune system diseases requiring oral corticosteroid treatment, were considered by the investigators to influence trial evaluators.
• Primary or secondary immunodeficiency (previous or current active).
• Previous or current cancer.
• A history of any lymphoproliferative disease, such as EBV-associated lymphoproliferative disease, lymphoma, leukemia, myeloproliferative disease, multiple myeloma, or signs and symptoms suggestive of current lymphoproliferative disease.
• The presence of serious, poorly controlled concomitant diseases, such as (but not limited to) neurological, cardiovascular, hepatic, renal, gastrointestinal, and endocrine diseases, which in the judgment of the investigator may prevent the subjects from participating in the study.
• Have any congenital or acquired neurological disease, vascular disease, or systemic disease, especially joint pain and swelling (e.g., Parkinson's disease, cerebral palsy, diabetic neuropathy) that may affect the evaluation of the effectiveness of this study.
• The following infections are known: Recurrent active bacteria, viruses, fungi, mycobacteria infection or other (including but not limited to, and atypical mycobacteria tuberculosis disease, chest X-ray examination showed granulomatous disease, hepatitis c virus (HCV) infection, HIV infection, herpes zoster, but does not include the nail bed fungus infection), or 6 months before the filter has a history of chronic infection, Or any major episode of infection requiring hospitalization or intravenous antibiotic treatment within 4 weeks prior to screening or oral antibiotic treatment within 2 weeks prior to screening, or a history of tuberculosis; For those who screened positive for TB, enrollment was determined by the investigator after prophylactic treatment.
• Subjects who received live/attenuated/inactivated COVID-19 vaccine within 4 weeks prior to the screening visit or were known to receive live/attenuated/inactivated COVID-19 vaccine during the 12-week treatment observation period.
• Patients who had used lymphocyte depletion agents/therapies, alkylating agents, total lymphoid irradiation, or other therapies before screening or planned to use them during the study.

Sponsors & Collaborators

• Beijing VDJBio Co., LTD.: lead

Study Sites (15)

Peking University People's Hospital

Beijing, Beijing Municipality, 010000, China

Location

Baoji Central Hospital

Baoji, China

Location

Beijing Hospital

Beijing, China

Location

The First Affiliated Hospital of Bengbu Medical College

Bengbu, China

Location

Chenzhou First People's Hospital

Chenzhou, China

Location

Pingxiang People's Hospital

Jiangxi, China

Location

Jilin Province People's Hospital

Jilin, China

Location

Affiliated Hospital of North Sichuan Medical College

Nanchong, China

Location

Drum Tower Hospital Affiliated to Nanjing University Medical School

Nanjing, China

Location

Puyang Oilfield General Hospital

Pujiang, China

Location

Qilu Hospital of Shandong University

Shandong, China

Location

Peking University Shenzhen Hospital

Shenzhen, China

Location

People's Hospital of Xinjiang Uygur Autonomous Region

Xinjiang, China

Location

Zaozhuang Municipal Hospital

Zaozhuang, China

Location

The First Affiliated Hospital of Zhengzhou University

Zhengzhou, China

Location

MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

tocilizumab

Condition Hierarchy (Ancestors)

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

Study Officials

• Zhan-guo Li

  Peking University People's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 11, 2023
• First Posted: July 24, 2023
• Study Start: May 26, 2022
• Primary Completion: June 2, 2023
• Study Completion: June 2, 2023
• Last Updated: July 9, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (15)