CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 503 enrolled
Drug / intervention
Stelara® (Ustekinumab) +1 moredrug
Likely dose
Stelara® (Ustekinumab) 45 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04967508
NCT04967508Phase 3Completed
CompareCT.gov

A Phase III, Randomised, Double-blind, Multicentre Clinical Study to Evaluate the Efficacy, Safety, Tolerability, Pharmacokinetics, and Immunogenicity of SB17 (Proposed Ustekinumab Biosimilar) Compared to Stelara® in Subjects With Moderate to Severe Plaque Psoriasis

Samsung Bioepis Co., Ltd.·interventional·Posted Jul 19, 2021·Updated May 25, 2025

In Brief

A Phase 3 clinical trial evaluating Stelara® (Ustekinumab) and SB17 (Proposed Ustekinumab Biosimilar) for Psoriasis and Moderate to Severe Plaque Psoriasis. Completed, enrolled 503 participants across 32 sites in 8 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPsoriasis, Moderate to Severe Plaque Psoriasis
CountriesCzechia, Estonia, Hungary, Latvia, Lithuania, Poland, South Korea, Ukraine
Collaborators--

Timeline

Phase 3CompletedFinished
20222023202420252026
First PostedJul 19, 2021
Enrollment StartJul 6, 2021
Primary CompletionFeb 24, 2022
Study CompletionNov 25, 2022
TodayJul 2, 2026
Enrollment to primary: 8 monthsPosted 5.0 years ago

Interventions

Stelara® (Ustekinumab)drug

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.

SB17 (Proposed Ustekinumab Biosimilar)drug

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.