NCT05377944

Assessment on Efficacy and Safety of BAT2306 and Cosentyx® in Plaque Psoriasis Patients

A Multicenter, Randomized, Double-Blind, Parallel-Arm, Phase 3 Study to Compare Efficacy and Safety of BAT2306 With Cosentyx® in Patients With Moderate to Severe Plaque Psoriasis

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 502 (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 BAT2306 with Cosentyx in patients with moderate to severe plaque psoriasis. The study is composed of a ≤ 28-day screening period, a 24-week initial treatment period (Treatment Period 1 \[TP1\]), and a 28-week secondary treatment period (Treatment Period 2 \[TP2\]). The study will be a maximum of 56 weeks.

Detailed description

Primary objective: • To demonstrate equivalent efficacy of BAT2306 and Cosentyx® in patients with moderate to severe plaque psoriasis. Secondary objectives: * To evaluate the efficacy of BAT2306 compared with Cosentyx over the study period based on secondary efficacy endpoints. * To evaluate the safety and tolerability of BAT2306 compared with Cosentyx over the study period. * To evaluate the immunogenicity of BAT2306 compared with Cosentyx over the study period. * To evaluate the steady-state pharmacokinetics (PK) of BAT2306 compared with Cosentyx. * To assess safety and immunogenicity after transition from Cosentyx to BAT2306.

Conditions

• Plaque Psoriasis

Interventions

Type	Name	Description
DRUG	BAT2306	150 mg/1 ml/injection (2 injections/visit)
DRUG	EU-approved Cosentyx	150 mg/1 ml/injection (2 injections/visit)

Timeline

• Start date: 2022-10-26
• Primary completion: 2024-05-24
• Completion: 2024-12-10
• First posted: 2022-05-17
• Last updated: 2025-04-23

Locations

1 site across 1 country: China