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

Sponsor
Bio-Thera Solutions
Study ID
NCT05377944
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • BAT2306 — DRUG
    150 mg/1 ml/injection (2 injections/visit)
  • EU-approved Cosentyx — DRUG
    150 mg/1 ml/injection (2 injections/visit)

Study Details

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.

Key Dates

Start date
Oct 26, 2022
Status verified
Oct 2024
Primary completion
May 24, 2024
Completion
Dec 10, 2024

Study Design

Enrollment
502 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: BAT2306
    Patients will receive subcutaneous treatment of 300 mg BAT2306 (2 injections of 150 mg/1 ml) via PFS at weeks 0, 1, 2, 3, and 4 followed by dosing every 4 weeks, thereafter up to Week 40.
  • Active Comparator: EU-approved Cosentyx
    Patients will receive subcutaneous treatment of 300 mg EU-approved Cosentyx (2 injections of 150 mg/1 ml) at weeks 0, 1, 2, 3, and 4 followed by dosing every 4 weeks, thereafter up to Week 40.

Primary Outcome Measure

Psoriasis Area and Severity Index (PASI) [ Time Frame: 0-8 weeks(EMA, PMDA) or 0-12 weeks(FDA, NMPA) ]

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