drugset / Trial / NCT04728360

Comparative Study of BAT2206 With Stelara® in Patients With Moderate to Severe Plaque Psoriasis

NCT04728360

Phase 3 Completed 556 enrolled Bio-Thera Solutions
RandomizedParallel-groupQuadruple-blindTreatment

Summary

This study is a multicenter, randomized, double-blind, parallel-arm, Phase 3 study designed to compare efficacy, safety, immunogenicity, and PK of BAT2206 with Stelara in patients with moderate to severe plaque psoriasis. The study is composed of a ≤ 28-day screening period, a 16-week initial treatment period (TP1), a 24-week secondary treatment period (TP2), a 12-week efficacy and safety follow-up period up to end-of-study visit, for a maximum total study duration of 56 weeks.

Timeline

Start
2021-07-06
Primary completion
2022-10-12
Completion
2023-07-07

Drugs

EvaluationDrugModalityDoseRoute
Subject BAT2206 Unknown 45 mg Subcutaneous
Comparator Ustekinumab Monoclonal antibody 45 mg Subcutaneous
Comparator Ustekinumab Monoclonal antibody 90 mg Subcutaneous

Indications