Trials / Completed
CompletedNCT05957107
Phase II Trial of VDJ001 in Patients With Moderate-to-severe Active Rheumatoid Arthritis
Randomized, Double-blind, Placebo, Positive-controlled Phase II Trial of VDJ001 in Patients With Moderate-to-severe Active Rheumatoid Arthritis
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 181 (actual)
- Sponsor
- Beijing VDJBio Co., LTD. · Industry
- Sex
- All
- Age
- 18 Years – 75 Years
- Healthy volunteers
- Not accepted
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.
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).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | Recombinant Humanized Anti-interleukin-6 Receptor Monoclonal Antibody Injection | The drug was administered once every 4 weeks. |
Timeline
- Start date
- 2022-05-26
- Primary completion
- 2023-06-02
- Completion
- 2023-06-02
- First posted
- 2023-07-24
- Last updated
- 2025-07-09
Locations
15 sites across 1 country: China
Source: ClinicalTrials.gov record NCT05957107. Inclusion in this directory is not an endorsement.