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Rheumatoid ArthritisPhase 2NCT05957107

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

A Phase 2 study testing Recombinant Humanized Anti-interleukin-6 Receptor Monoclonal Antibody Injection in people with Rheumatoid Arthritis, run by Beijing VDJBio Co., LTD. at 15 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Rheumatoid Arthritis
What is being tested?
Recombinant Humanized Anti-interleukin-6 Receptor Monoclonal Antibody Injection
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
181 participants
Where
15 sitesChina
Study dates
26 May 2022to 2 Jun 2023
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
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  • 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.
  • Previous treatment with IL-6 and IL-6R inhibitors.
  • Use biological DMARDs at the following times:
  • Anapheresis, etanercept: within 28 days before administration;
  • Adalimumab, infliximab: within 56 days before administration;
  • Golimumab and cetuzumab: within 70 days before administration;
  • Abacept: within 84 days before administration;
  • Denoxemide: within 150 days before administration;
  • Rituximab: within 180 days before administration.
  • Abiotic DMARDs other than MTX were administered within 28 days prior to dosing (subjects without chloroquine, hydroxychloroquine, leflunomide within 56 days prior to dosing, or no more than 28 days after standard koleenamine treatment or active carbon washout were not eligible).
  • Had received intra-articular or extra-intestinal corticosteroid therapy within 28 days prior to dosing.
  • Who had been immunized with genofin, gold thiodextrose (gold for injection), gold thiomalate (gold for injection), or oral polio vaccine within 56 days prior to administration.
  • Patients who received intravenous immunoglobulin, plasma exchange or Prosorba column within 24 weeks before screening.
  • Participated in clinical studies of other drugs within 1 month prior to screening or within 5 half-lives of other experimental drugs, whichever is longer.
  • Hepatitis B surface antigen (HBsAg) positive, or if hepatitis B core antibody (HBcAb) positive, HBV DNA test is added and HBV DNA> the lower limit of detection.
  • The laboratory test value (retest is allowed, and the last test result shall prevail) meets any of the following conditions:
  • Serum creatinine: female subjects had serum creatinine >1.4 mg per deciliter (124 μmol per liter); Serum creatinine > 1.6 mg/dL (141 μmol/L) in male subjects;
  • ALT or AST> 1.5 times the upper limit of normal (ULN);
  • Platelet count <80×109/ L;
  • the WBC < 3.5 x 109 / L;
  • Total bilirubin > 1.5 times ULN.
  • Female subjects who had a positive pregnancy test during pregnancy, or breastfeeding, or screening, or who were unable to use effective contraception from the screening period until 6 months after completion or termination of the trial (including male subjects and their female spouses).
  • Other ineligible subjects were judged by the investigator.

Trial locations and contacts

15 sites in 1 country.

15 sites in 1 country

China15 sites

  • Baoji Central Hospital

    Baoji

  • Peking University People's Hospital

    Beijing, Beijing Municipality, 010000

  • Beijing Hospital

    Beijing

  • The First Affiliated Hospital of Bengbu Medical College

    Bengbu

  • Chenzhou First People's Hospital

    Chenzhou

  • Pingxiang People's Hospital

    Jiangxi

  • Jilin Province People's Hospital

    Jilin City

  • Affiliated Hospital of North Sichuan Medical College

    Nanchong

  • Drum Tower Hospital Affiliated to Nanjing University Medical School

    Nanjing

  • Puyang Oilfield General Hospital

    Pujiang

  • Qilu Hospital of Shandong University

    Shandong

  • Peking University Shenzhen Hospital

    Shenzhen

  • People's Hospital of Xinjiang Uygur Autonomous Region

    Xinjiang

  • Zaozhuang Municipal Hospital

    Zaozhuang

  • The First Affiliated Hospital of Zhengzhou University

    Zhengzhou

Other trials in China

About this study

Official title: Randomized, Double-blind, Placebo, Positive-controlled Phase II Trial of VDJ001 in Patients With Moderate-to-severe Active Rheumatoid Arthritis

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.

Read the detailed description

After screening, eligible subjects were randomly assigned in a 1:1:1:1 ratio to VDJ001 4 mg/kg group, VDJ001 6 mg/kg group, placebo group, and tocilizumab group to receive trial drug or control drug every 4 weeks. The treatment course was 12 weeks (D1, W4, W8 administration, followed up to W12).

Being tested
Recombinant Humanized Anti-interleukin-6 Receptor Monoclonal Antibody Injection
Medical subject headings
Arthritis, Rheumatoid

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Recombinant Humanized Anti-interleukin-6 Receptor Monoclonal Antibody InjectionBiological

    Also called Tocilizumab Injection, placebo control

    The drug was administered once every 4 weeks.

Study groups in NCT05957107
Study groupRoleWhat they receive
Injection of recombinant humanized monoclonal antibody against interleukin-6 receptor 4 mg/kgExperimentalRecombinant Humanized Anti-interleukin-6 Receptor Monoclonal Antibody Injection 4 mg/kg as the low dose group.
Receives: Biological: Recombinant Humanized Anti-interleukin-6 Receptor Monoclonal Antibody Injection
Injection of recombinant humanized monoclonal antibody against interleukin-6 receptor6mg/kgExperimentalRecombinant Humanized Anti-interleukin-6 Receptor Monoclonal Antibody Injection 6mg/kg as the middle dose group.
Receives: Biological: Recombinant Humanized Anti-interleukin-6 Receptor Monoclonal Antibody Injection
placebo controlExperimentalplacebo control
Receives: Biological: Recombinant Humanized Anti-interleukin-6 Receptor Monoclonal Antibody Injection
Tocilizumab Injection8mg/kgExperimentalTocilizumab Injection8mg/kg
Receives: Biological: Recombinant Humanized Anti-interleukin-6 Receptor Monoclonal Antibody Injection

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 12 weeks

Secondary outcomes (10)

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

    Proportion of patients who achieved American College of Rheumatology 50%, 70% improvement criteria at week 12.

    Measured: 12 weeks

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

    DAS28-CRP=0.56*(TJC28)1/2+0.28*(SJC28)1/2+0.014*GH+0.36*ln(CRP+1)+0.96; DAS28-ESR=0.56*(TJC28)1/2+0.28*(SJC28)1/2+0.014*GH+0.70*ln(ESR); In the formula, TJC28 = joint count of pressure and pain at 28 joints, SJC28 = joint count of swelling at 28 joints, GH = general health status, i.e., patient's overall assessment of disease activity, ln = natural logarithm.

    Measured: 12 weeks

  3. 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.

    CDAI=TJC28+SJC28+PGA+PhGA In the formula, TJC28 = joint counts of pressure and pain at 28 joints, SJC28 = joint counts of swelling at 28 joints,PhGA stands for physician's global visual analogue scale of disease activity in cm, and PtGA stands for patient's global visual analogue scale of disease activity in cm.

    Measured: 12 weeks

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

    Morning stiffness refers to the phenomenon that the diseased joints are stiff for a longer period of time in the morning after standing still, such as the feeling of glue, which is gradually reduced after appropriate activities.

    Measured: 12 weeks

  5. Patient ratings of arthralgia

    Change in patient rating of arthralgia (PtAAP) at week 12 relative to baseline and rate of change.

    Measured: 12 weeks

  6. Patient's overall assessment of the condition

    Patient's overall assessment of the condition (PtGA) at week 12 change from baseline and rate of change.

    Measured: 12 weeks

  7. Physician's Global Assessment of Condition

    Change in Physician's Global Assessment of Condition (PhGA) relative to Baseline and Rate of Change at Week 12.

    Measured: 12 weeks

  8. Patient Health Assessment Questionnaire

    Change in Patient Health Assessment Questionnaire (HAQ-DI) Score Relative to Baseline and Rate of Change at Week 12.

    Measured: 12 weeks

  9. Health Status Questionnaire (SF-36)

    Change from baseline in Week 12 Health Status Questionnaire (SF-36) scores and rate of change.

    Measured: 12 weeks

  10. Functional Assessment of Chronic Illness Therapy-Fatigue Scale

    Change from baseline and rate of change in Functional Assessment of Chronic Illness Therapy-Fatigue Scale (FACIT-F) score at week 12.

    Measured: 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Jul 2023
  2. Study start26 May 2022
  3. Primary completion2 Jun 2023
  4. Study completion2 Jun 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
181 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05957107
Sponsor's protocol ID
VDJ001-RA-II
Status last verified
Jul 2025
First submitted
11 Jul 2023
Last updated
9 Jul 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Recombinant Humanized Anti-interleukin-6 Receptor Monoclonal Antibody Injection in people with Rheumatoid Arthritis, run by Beijing VDJBio Co., LTD. at 15 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 37 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 15 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Proportion of patients who achieved ACR20 at week 12. (time frame: 12 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05957107.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jul 2025.

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