NCT04728360

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

A Multicenter, Randomized, Double-Blind, Parallel-Arm, Phase 3 Study to Compare Efficacy and Safety of BAT2206 With Stelara® in Patients With Moderate to Severe Plaque Psoriasis

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 556 (actual)
• Sponsor: Bio-Thera Solutions · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Plaque Psoriasis

Interventions

Type	Name	Description
DRUG	BAT2206	45 mg/0.5 mL
DRUG	Stelara (EU-sourced)	45 mg/0.5 mL

Timeline

• Start date: 2021-07-06
• Primary completion: 2022-10-12
• Completion: 2023-07-07
• First posted: 2021-01-28
• Last updated: 2023-07-21

Locations

1 site across 1 country: China