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

Sponsor
Samsung Bioepis Co., Ltd.
Study ID
NCT04967508
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

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.

Study Details

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.

Key Dates

Start date
Jul 6, 2021
Status verified
May 2025
Primary completion
Feb 24, 2022
Completion
Nov 25, 2022

Study Design

Enrollment
503 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: SB17 (Proposed Ustekinumab Biosimilar)
  • Active Comparator: Stelara® (Ustekinumab)

Primary Outcome Measure

Percent Change From Baseline in PASI at Week 12 [ Time Frame: Baseline and Week 12 ]

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