NCT04595409View on ClinicalTrials.gov

A Double-blind Study to Compare the Efficacy, Safety, and Immunogenicity of the Proposed Biosimilar Ustekinumab FYB202 to Stelara® in Patients With Moderate-to-Severe Plaque Psoriasis

PHASE3CompletedINTERVENTIONAL
Enrollment

392

Participants

Timeline

Start Date

November 9, 2020

Primary Completion Date

June 7, 2021

Study Completion Date

March 21, 2022

Conditions
Plaque Psoriasis
Interventions
DRUG

FYB202 (Proposed ustekinumab biosimilar)

Patients will receive 1 subcutaneous (SC) injection of FYB202 at week 0 and week 4, followed by 1 SC injection every 12 weeks thereafter for the next 3 consecutive doses.

DRUG

Stelara® (Ustekinumab)

Patients will receive 1 subcutaneous (SC) injection of Stelara® at week 0 and week 4, followed by 1 SC injection every 12 weeks thereafter for the next 3 consecutive doses.

Trial Locations (16)

Unknown

Research Site, Tallinn

Research Site, Tartu

Research Site, Tbilisi

Research Site, Bialystok

Research Site, Gdansk

Research Site, Krakow

Research Site, Lodz

Research Site, Olsztyn

Research Site, Torun

Research Site, Warsaw

Research Site, Wroclaw

Research Site, Dnipro

Research Site, Kharkiv

Research Site, Kyiv

Research Site, Rivne

Research Site, Zaporizhzhya

All Listed Sponsors
lead

Bioeq GmbH

INDUSTRY

NCT04595409 - A Double-blind Study to Compare the Efficacy, Safety, and Immunogenicity of the Proposed Biosimilar Ustekinumab FYB202 to Stelara® in Patients With Moderate-to-Severe Plaque Psoriasis | Biotech Hunter | Biotech Hunter