drugset / Trial / NCT05046431

Comparative Study of BAT2506 With Simponi® in Participants With Active Psoriatic Arthritis

NCT05046431

Phase 3 Completed 704 enrolled Bio-Thera Solutions
RandomizedParallel-groupQuadruple-blindTreatment

Summary

This is a multicenter, double-blind, randomized, parallel-group study to compare the efficacy,pharmacodynamics (PD), pharmacokinetics (PK), safety, and immunogenicity of BAT2506 versus Simponi® in participants with active PsA. The study will consist of up to 4-week Screening Period, a 52-week Treatment Period, and a 8-week Safety Follow-up Period.

Timeline

Start
2021-05-06
Primary completion
2023-10-06
Completion
2023-10-06

Drugs

EvaluationDrugModalityDoseRoute
Subject BAT2506 Unknown 50 mg
Comparator Golimumab Monoclonal antibody 50 mg

Indications