drugset / Trial / NCT04967508

A Study to Compare SB17 (Proposed Ustekinumab Biosimilar) to Stelara® in Subject With Moderate to Severe Plaque Psoriasis

NCT04967508

Phase 3 Completed 503 enrolled Samsung Bioepis Co., Ltd.
RandomizedParallel-groupQuadruple-blindTreatment

Summary

This is a randomised, double-blind, multicentre clinical study to evaluate the efficacy, safety, tolerability, PK, and immunogenicity of SB17 compared to Stelara® in subjects with moderate to severe plaque psoriasis.

Timeline

Start
2021-07-06
Primary completion
2022-02-24
Completion
2022-11-25

Drugs

EvaluationDrugModalityDoseRoute
Subject SB17 Unknown 45 mg Subcutaneous
Comparator Ustekinumab Monoclonal antibody 45 mg Subcutaneous

Indications