A Study to Investigate Interchangeability of ABP 654 for the Treatment of Participants With Moderate to Severe Plaque Psoriasis

Conditions

• Psoriasis

Eligibility Criteria

Sex

ALL

Age

18 Years - 75 Years

Healthy Volunteers

Not accepted

Interventions

• Ustekinumab — DRUG
  Participants will receive subcutaneous (SC) injection of ustekinumab.
• ABP 654 — DRUG
  Participants will receive SC injection of ABP 654.

Study Details

The purpose of the study is to evaluate pharmacokinetic similarity, efficacy, safety and immunogenicity of multiple switches between ustekinumab and ABP 654 compared with continued use of ustekinumab in participants with moderate to severe plaque psoriasis.

Key Dates

Start date

Mar 24, 2021

Status verified

Jan 2024

Primary completion

Feb 28, 2023

Completion

Feb 28, 2023

Study Design

Enrollment

494 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Active Comparator: Continued-use Group (Ustekinumab)
  Participants will receive subcutaneous injection of ustekinumab up to Week 52.
• Experimental: Switching Group (Ustekinumab - ABP 654)
  Participants will initially receive injection of ustekinumab up to Week 16. Thereafter, starting from Week 28, participants will switch between ABP 654 and ustekinumab every 12 weeks up to Week 52.

Primary Outcome Measure

Area Under the Plasma Concentration Time Curve (AUC) Over the Dosing Interval (AUCtau) Between Week 52 and Week 64 [ Time Frame: Blood samples were taken pre-dose week 52; and at 2 days, 7 days, 10 days, 2 weeks, 4 weeks, 8 weeks, and 12 weeks after the week 52 dose ]

Locations (31)

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