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

NCT05377944 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 502

Last updated 2025-04-23

No results posted yet for this study

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.

Conditions

Interventions

DRUG

BAT2306

150 mg/1 ml/injection (2 injections/visit)

DRUG

EU-approved Cosentyx

150 mg/1 ml/injection (2 injections/visit)

Sponsors & Collaborators

Principal Investigators

  • Min Zheng · Second Affiliated Hospital, School of Medicine, Zhejiang University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-10-26
Primary Completion
2024-05-24
Completion
2024-12-10

Countries

  • China

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05377944 on ClinicalTrials.gov