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

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

Outcome

Met primary endpoint

release “SB17(스텔라라 바이오시밀러) 임상 3상 결과 오리지널약 대비 동등성 확인” samsungbioepis.com ↗

release “1차 유효성 평가지표(primary endpoint)로 12주차 건선 중증도 지수(PASI: Psoriasis Area and Severity Index)의 기준치(baseline) 대비 변화율을 측정했으며, 그 결과 사전에 정의한 동등성 기준3)을 충족했다.” samsungbioepis.com ↗

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	SB17	Unknown	45 mg	Subcutaneous
Comparator	Ustekinumab	Monoclonal antibody	45 mg	Subcutaneous

Indications