drugset / Trial / NCT06726096

Phase III Trial of VDJ001 In Patients With Moderate-to-severe Active Rheumatoid Arthritis

NCT06726096

Phase 3 Enrolling by invitation 615 enrolled Beijing VDJBio Co., LTD.
RandomizedParallel-groupDouble-blindTreatment

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

Timeline

Start
2025-04-09
Primary completion
2026-04-20
Completion
2026-12-31

Drugs

EvaluationDrugModalityDoseRoute
Subject Tocilizumab Monoclonal antibody 8 mg/kg
Subject VDJ001 Monoclonal antibody 6 mg/kg

Indications