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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
502
150 mg/1 ml/injection (2 injections/visit)
150 mg/1 ml/injection (2 injections/visit)
The Second Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou, Zhejiang, China
Psoriasis Area and Severity Index (PASI)
* EMA, PMDA, and Agencies other than the FDA and NMPA: Percent change from baseline in Psoriasis Area and Severity Index (PASI) score to Week 8 * FDA and NMPA: Percent change from baseline in PASI score to Week 12 Minimum value 0, maximum value 72. Higher score means worse outcome.
Time frame: 0-8 weeks(EMA, PMDA) or 0-12 weeks(FDA, NMPA)
Psoriasis Area and Severity Index (PASI) score
Percentage change from baseline in PASI score at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, and 44. Minimum value 0, maximum value 72. Higher score means worse outcome.
Time frame: Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, and 44
PASI-50/75/90/100
Proportion of patients who achieve at least 50/75/90/100% improvement from baseline in PASI (PASI-50/75/90/100) at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, and 44. Higher score means better outcome
Time frame: Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, and 44
Investigator's Global Assessment (IGA)
Change from baseline in Investigator's Global Assessment (IGA mod 2011) at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, and 44. Minimum value 0, maximum value 4. Higher score means worse outcome.
Time frame: Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, and 44
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