NCT04967508View on ClinicalTrials.gov

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

PHASE3CompletedINTERVENTIONAL
Enrollment

503

Participants

Timeline

Start Date

July 6, 2021

Primary Completion Date

February 24, 2022

Study Completion Date

November 25, 2022

Conditions
PsoriasisModerate to Severe Plaque Psoriasis
Interventions
DRUG

Stelara® (Ustekinumab)

Subjects randomised into Stelara® group will receive Stelara® (45 mg) via subcutaneous injection at Week 0, 4, and then every 12 weeks up to Week 40.

DRUG

SB17 (Proposed Ustekinumab Biosimilar)

"Subjects randomised into SB17 group will receive SB17 (45 mg) via subcutaneous injection at Week 0, 4, and then every 12 weeks up to Week 40.~Starting at Week 28, subjects transited from Stelara® to SB17 will receive SB17 via subcutaneous injection."

Trial Locations (32)

Unknown

SB Investigative Site, Brno

SB Investigative Site, Ostrava

SB Investigative Site, Pardubice

SB Investigative Site, Prague

SB investigative site, Tallinn

SB Investigative Site, Tartu

SB Investigative Site, Zalaegerszeg

SB Investigative Site, Riga

SB Investigative Site, Talsi

SB Investigative Site, Kaunas

SB Investigative Site, Vilnius

SB Investigative Site, Elblag

SB Investigative Site, Kielce

SB Investigative Site, Krakow

SB Investigative Site, Lodz

SB Investigative Site, Lublin

SB Investigative Site, Rzeszów

SB Investigative Site, Siedlce

SB Investigative Site, Skierniewice

SB Investigative Site, Świdnik

SB Investigative Site, Warsaw

SB Investigative Site, Seongnam

SB Investigative Site, Suwon

SB Investigative Site, Dnipro

SB Investigative Site, Kharkiv

SB Investigative Site, Kherson

SB Investigative Site, Kyiv

SB Investigative Site, Lviv

SB Investigative Site, Odesa

SB Investigative Site, Uzhhorod

SB Investigative Site, Vinnytsia

SB Investigative Site, Zaporizhzhia

All Listed Sponsors
lead

Samsung Bioepis Co., Ltd.

INDUSTRY