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NCT06726096
Phase III Trial of VDJ001 In Patients With Moderate-to-severe Active Rheumatoid Arthritis
Phase 3 trial testing Recombinant Humanized Anti-interleukin-6 Receptor Monoclonal Antibody Injection in Rheumatoid Arthritis (RA) in 615 participants. Enrolling by invitation.
20 April 2026
Quick facts
| Lead sponsor | Beijing VDJBio Co., LTD. |
|---|---|
| Phase | Phase 3 |
| Status | ENROLLING BY INVITATION |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | double |
| Primary purpose | treatment |
| Enrollment | 615 |
| Start date | 9 April 2025 |
| Primary completion | 20 April 2026 |
| Estimated completion | 31 December 2026 |
| Sites | 1 location across China |
Drugs / interventions tested
- Recombinant Humanized Anti-interleukin-6 Receptor Monoclonal Antibody Injection — full drug profile →
Conditions studied
- Rheumatoid Arthritis (RA) — all drugs for Rheumatoid Arthritis (RA) →
- Anti IL-6R — all drugs for Anti IL-6R →
Sponsor
Beijing VDJBio Co., LTD. — full company profile →
Who can join
Adults 18 to 75, any sex, with Rheumatoid Arthritis (RA) or Anti IL-6R. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT06726096
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Recombinant Humanized Anti-interleukin-6 Receptor Monoclonal Antibody Injection
Trials testing the same drug.
- NCT05957107 — Phase II Trial of VDJ001 in Patients With Moderate-to-severe Active Rheumatoid Arthritis · Phase 2 · completed
Other recruiting trials for Rheumatoid Arthritis (RA)
Currently open trials in the same condition.
- NCT07087912 — Safety and Immunogenicity of the Live Attenuated Tetravalent Butantan-Dengue Vaccine in Autoimmune Rheumatic Diseases · Phase 4 · recruiting
- NCT07438652 — Effect of Mediterranean vs Paleolithic Diet on RA Activity, Sarcopenia and QOL: 12-Week RCT · NA · recruiting
- NCT07264101 — Validity And Reliability Of The Four Square Step Test In Individuals With Rheumatoid Arthritis · recruiting
- NCT07221890 — A Trial of Academic Detailing to Promote Prescribing of Biosimilars · NA · active not recruiting
- NCT07100873 — A Phase 1 Study of ADI-001 in Rheumatoid Arthritis · Phase 1 · recruiting
Other Beijing VDJBio Co., LTD. trials
Trials by the same sponsor.
- NCT05957107 — Phase II Trial of VDJ001 in Patients With Moderate-to-severe Active Rheumatoid Arthritis · Phase 2 · completed
- NCT05345522 — A Study of Anti-IL-6R mAb Injection in Patients With iMCD · Phase 2 · active not recruiting
- NCT05256719 — Clinical Study of Recombinant Humanized CTLA-4-FC Fusion Protein Injection in Healthy Subjects · Phase 1 · recruiting
- NCT05232396 — Clinical Study of Single Dose IL-6R mAb Injection in RA Patients · Phase 1 · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06726096 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Beijing VDJBio Co., LTD.
- Last refreshed: 11 August 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06726096.
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