Rheumatoid Arthritis (RA)Phase 3NCT06726096
Phase III Trial of VDJ001 In Patients With Moderate-to-severe Active Rheumatoid Arthritis
A Phase 3 study testing Recombinant Humanized Anti-interleukin-6 Receptor Monoclonal Antibody Injection in people with Rheumatoid Arthritis (RA) and Anti IL-6R, run by Beijing VDJBio Co., LTD. at 1 site in China.
Trial summary
A multicenter, randomized, double-blind, placebo-controlled, and active drug-controlled Phase III pivotal clinical trial of recombinant humanized anti-interleukin-6 receptor monoclonal antibody injection (VDJ001) for the treatment of moderate-to-severe active rheumatoid arthritis with poor response to methotrexate Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Rheumatoid Arthritis (RA), Anti IL-6R
- What is being tested?
- Recombinant Humanized Anti-interleukin-6 Receptor Monoclonal Antibody Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 615 participants
- Where
- 1 siteChina
- Study dates
- 9 Apr 2025to 31 Dec 2026
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
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
- Voluntarily sign the informed consent form;
- Age between 18 and 75 years inclusive;
- Diagnosed with RA according to the 1987 American College of Rheumatology (ACR) criteria or the 2010 ACR and European League Against Rheumatism (EULAR) classification criteria;
- At the time of screening, judged to have moderate to severe active RA based on the following criteria: joint swelling count ≥6 (out of 66 joints) and joint tenderness count ≥6 (out of 68 joints), and must also meet C-reactive protein (CRP)/High-sensitivity C-reactive protein (hsCRP) ≥ upper limit of normal (ULN) or erythrocyte sedimentation rate (ESR) ≥28 mm/h;
- Have been receiving oral methotrexate (MTX) treatment for at least 12 weeks and at a stable dose (MTX dose of 7.5~25 mg/week) for at least 4 weeks prior to randomization; subjects with a history of parenteral MTX (subcutaneous, intramuscular, or intravenous injection) are eligible for the study, but these subjects must have been receiving a stable dose of MTX 7.5~25 mg/week oral treatment for ≥4 weeks prior to randomization;
- At the time of screening, if the subject is taking prednisone or an equivalent dose of corticosteroids, they must have been on a stable dose (prednisone dose ≤10mg/day) for at least 4 weeks prior to randomization.
Who cannot join
- Body weight >100 kg or <40 kg;
- ACR functional class IV or long-term bedridden/wheelchair-bound individuals;
- Individuals with an allergic constitution or known allergies to any components of the study treatment or other similar products;
- Investigators determine that surgeries previously received by the subject or planned surgeries may affect the assessment of joint study evaluations;
- Patients with rheumatic immune diseases other than rheumatoid arthritis, uncontrolled immune system diseases requiring oral corticosteroid treatment, which the investigator deems may affect trial evaluation;
- Primary or secondary immunodeficiency diseases (past or currently active);
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- History of or current tumors (except for cured and non-recurrence for at least 5 years of skin basal cell carcinoma, squamous cell carcinoma, cervical carcinoma in situ, breast ductal carcinoma in situ, and papillary thyroid carcinoma);
- History of any lymphoproliferative diseases, such as EBV-related lymphoproliferative diseases, lymphoma, leukemia, myeloproliferative diseases, multiple myeloma, or signs and symptoms suggesting current lymphatic diseases;
- Presence of severe, poorly controlled comorbidities, such as (but not limited to) neurological, cardiovascular, liver, kidney, gastrointestinal, endocrine diseases, which the investigator judges may hinder the subject's participation in this study;
- Known to have the following infections: recurrent active bacterial, viral, fungal, mycobacterial, or other infections [including but not limited to tuberculosis and atypical mycobacterial disease, granulomatous disease found on chest X-ray, hepatitis C virus infection, human immunodeficiency virus (HIV) infection, and herpes zoster, but excluding nail bed fungal infections], or a history of chronic infections within the last 6 months, or any major infection requiring hospitalization for treatment or intravenous antibiotic treatment within 4 weeks before screening or oral antibiotic treatment within 2 weeks before screening;
- Subjects who have received live vaccines/attenuated vaccines within 4 weeks before the screening visit or are known to receive live vaccines/attenuated vaccines during the 12-week treatment observation period;
- Subjects who have used or plan to use lymphocyte-depleting agents/therapies, alkylating agents, total lymphoid irradiation, or other treatment methods during the study period;
- Individuals who have previously received IL-6 and IL-6R inhibitor treatment;
- Use of biological disease-modifying anti-rheumatic drugs (bDMARDs) within 4 weeks or 5 half-lives (whichever is longer) before randomization: such as TNF-α inhibitors, biosimilars, and RA drugs used in clinical trials;
- Use of non-biological DMARDs other than MTX within 28 days before dosing (excluding chloroquine and hydroxychloroquine, subjects who have used leflunomide within 140 days before dosing or have undergone standard cholestyramine treatment or activated charcoal washout within 28 days before dosing are not eligible for the trial);
- Receipt of intra-articular or extra-articular (intramuscular, intravenous) corticosteroid treatment within 28 days before dosing;
- Participation in other drug clinical studies within 1 month or 5 half-lives (whichever is longer) of other trial drugs before screening;
- Hepatitis B surface antigen (HBsAg) positive, or if hepatitis B core antibody (HBcAb) is positive, then HBV DNA is additionally checked and HBV DNA > lower limit of detection;
- Screening period laboratory test values (only one retest is allowed) meet any of the following conditions:
- Serum creatinine: Female subjects with serum creatinine > 1.4 mg/dL (124 μmol/L); male subjects with serum creatinine > 1.6 mg/dL (141 μmol/L);
- ALT or AST > 1.5 times the upper limit of normal (ULN);
- Platelet count < 80×10^9/L;
- WBC < 3.0×10^9/L;
- Total bilirubin > 1.5 times ULN;
- Neutrophil count < 1.5×10^9/L;
- Lymphocyte count < 0.5×10^9/L.
- Pregnant or breastfeeding women, or female subjects with positive pregnancy tests during the screening period/baseline period, or subjects (including male subjects and their female spouses) who cannot take effective contraceptive measures from the screening period to 6 months after completion or termination of the trial;
- Subjects whom the investigator deems otherwise unsuitable for participation in this study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Peking University People's Hospital
Beijing, Beijing Municipality, 010000
About this study
Official title: Randomized,Double-blind,Placebo,Positive-controlled Phase III Trial of VDJ001 In Patients With Moderate-to-severe Active Rheumatoid Arthritis
A multicenter, randomized, double-blind, placebo-controlled, and active drug-controlled Phase III pivotal clinical trial of recombinant humanized anti-interleukin-6 receptor monoclonal antibody injection (VDJ001) for the treatment of moderate-to-severe active rheumatoid arthritis with poor response to methotrexate
- Conditions
- Rheumatoid Arthritis (RA), Anti IL-6R
- 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
The drug was administered once every 4 weeks.
Other Names:
Tocilizumab Injection placebo control
| Study group | Role | What they receive |
|---|---|---|
| combinant humanized monoclonal antibody against interleukin-6 receptor 6 mg/kg | Experimental | Not described Receives: Biological: Recombinant Humanized Anti-interleukin-6 Receptor Monoclonal Antibody Injection |
| placebo control | Placebo comparator | Not described Receives: Biological: Recombinant Humanized Anti-interleukin-6 Receptor Monoclonal Antibody Injection |
| Tocilizumab Injection 8 mg/kg | Active comparator | Not described 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.
Proportion of subjects achieving ACR50 at week 24 (W24).
Proportion of patients who achieving American College of Rheumatology 50% improvement criteria (ACR20) at week 24.
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2024
- Study start9 Apr 2025
- Primary completion20 Apr 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rheumatoid Arthritis (RA)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 615 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing VDJBio Co., LTD.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06726096
- Sponsor's protocol ID
- VDJ001-RA-Ⅲ
- Status last verified
- Aug 2025
- First submitted
- 5 Dec 2024
- Last updated
- 11 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized,Double-blind,Placebo,Positive-controlled Phase III Trial of VDJ001 In Patients With Moderate-to-severe Active Rheumatoid Arthritis
- ClinicalTrials.gov ID
- NCT06726096
- Acronym / sponsor ID
- VDJ001-RA-Ⅲ
- Conditions
- Rheumatoid Arthritis (RA), Anti IL-6R
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 615 participants (estimated)
- Lead sponsor
- Beijing VDJBio Co., LTD.Industry (pharma, biotech, devices)
- Study start
- 9 Apr 2025 (actual)
- Primary completion
- 20 Apr 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 10 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A multicenter, randomized, double-blind, placebo-controlled, and active drug-controlled Phase III pivotal clinical trial of recombinant humanized anti-interleukin-6 receptor monoclonal antibody injection (VDJ001) for the treatment of moderate-to-severe active rheumatoid arthritis with poor response to methotrexate
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| combinant humanized monoclonal antibody against interleukin-6 receptor 6 mg/kg | Experimental | Biological: Recombinant Humanized Anti-interleukin-6 Receptor Monoclonal Antibody Injection |
| placebo control | Placebo comparator | Biological: Recombinant Humanized Anti-interleukin-6 Receptor Monoclonal Antibody Injection |
| Tocilizumab Injection 8 mg/kg | Active comparator | Biological: Recombinant Humanized Anti-interleukin-6 Receptor Monoclonal Antibody Injection |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Voluntarily sign the informed consent form;
- Age between 18 and 75 years inclusive;
- Diagnosed with RA according to the 1987 American College of Rheumatology (ACR) criteria or the 2010 ACR and European League Against Rheumatism (EULAR) classification criteria;
- At the time of screening, judged to have moderate to severe active RA based on the following criteria: joint swelling count ≥6 (out of 66 joints) and joint tenderness count ≥6 (out of 68 joints), and must also meet C-reactive protein (CRP)/High-sensitivity C-reactive protein (hsCRP) ≥ upper limit of normal (ULN) or erythrocyte sedimentation rate (ESR) ≥28 mm/h;
- Have been receiving oral methotrexate (MTX) treatment for at least 12 weeks and at a stable dose (MTX dose of 7.5~25 mg/week) for at least 4 weeks prior to randomization; subjects with a history of parenteral MTX (subcutaneous, intramuscular, or intravenous injection) are eligible for the study, but these subjects must have been receiving a stable dose of MTX 7.5~25 mg/week oral treatment for ≥4 weeks prior to randomization;
Key exclusion criteria (28 listed)
- Body weight >100 kg or <40 kg;
- ACR functional class IV or long-term bedridden/wheelchair-bound individuals;
- Individuals with an allergic constitution or known allergies to any components of the study treatment or other similar products;
- Investigators determine that surgeries previously received by the subject or planned surgeries may affect the assessment of joint study evaluations;
- Patients with rheumatic immune diseases other than rheumatoid arthritis, uncontrolled immune system diseases requiring oral corticosteroid treatment, which the investigator deems may affect trial evaluation;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Recombinant Humanized Anti-interleukin-6 Receptor Monoclonal Antibody InjectionThe drug was administered once every 4 weeks. Other Names: Tocilizumab Injection placebo control | Biological | Tocilizumab Injection 8 mg/kg, combinant humanized monoclonal antibody against interleukin-6 receptor 6 mg/kg, placebo control |
Primary outcome
Proportion of subjects achieving ACR50 at week 24 (W24).
Time frame: 24 weeks
Proportion of patients who achieving American College of Rheumatology 50% improvement criteria (ACR20) at week 24.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2025.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Recombinant Humanized Anti-interleukin-6 Receptor Monoclonal Antibody Injection in people with Rheumatoid Arthritis (RA) and Anti IL-6R, run by Beijing VDJBio Co., LTD. at 1 site 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 6 inclusion and 28 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: enrolling by invitation, as of the sponsor's last update on 11 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. Some participants in this study may receive a placebo. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
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 subjects achieving ACR50 at week 24 (W24). (time frame: 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 11 Aug 2025.