A Study to Compare SB17 (Proposed Ustekinumab Biosimilar) to Stelara® in Subject With Moderate to Severe Plaque Psoriasis
Phase 3
Completed
NCT04967508
| Condition | Psoriasis, Moderate to Severe Plaque Psoriasis |
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| Phase | Phase 3 |
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| Sponsor | Samsung Bioepis Co., Ltd. |
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| Status | Completed |
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| Enrollment | 503 participants |
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| Interventions | Stelara® (Ustekinumab), SB17 (Proposed Ustekinumab Biosimilar) |
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| Start date | Jul 6, 2021 |
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| Completion date | Feb 24, 2022 |
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| Results posted | May 25, 2025 |
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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.
Percent Change From Baseline in PASI at Week 12
Baseline and Week 12 · Percent change
| SB17 (Proposed Ustekinumab Biosimilar) | 85.7 ± 2.53 Percent change |
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| Stelara (Ustekinumab) | 86.3 ± 2.41 Percent change |
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Open in BENITIONS
View on ClinicalTrials.gov
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