Overview

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

Status:
Recruiting
Trial end date:
2023-05-30
Target enrollment:
Participant gender:
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.
Phase:
Phase 3
Details
Lead Sponsor:
Bio-Thera Solutions
Treatments:
Ustekinumab