A Comparative Study Between ABP 501 and Humira® in Participants With Moderate to Severe Plaque Psoriasis

Conditions

• Plaque Psoriasis

Eligibility Criteria

Sex

ALL

Age

18 Years - 75 Years

Healthy Volunteers

Not accepted

Interventions

• Adalimumab — DRUG
  Participants will receive subcutaneous (SC) injection of adalimumab
• ABP 501 — DRUG
  Participants will receive SC injection of ABP 501

Study Details

Study to evaluate pharmacokinetics, efficacy, safety and immunogenicity of multiple switches between Humira® and ABP 501 (new high concentration formulation) compared with continued use of Humira® in participants with moderate to severe plaque psoriasis. This multi-center study is composed of two periods: A lead-in period of treatment with Humira® followed by a randomized two parallel arm period.

Key Dates

Start date

Oct 4, 2021

Status verified

Feb 2024

Primary completion

Dec 19, 2022

Completion

Dec 19, 2022

Study Design

Enrollment

425 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Active Comparator: Continued-use Group (Adalimumab)
  Randomized participants will receive continuous injection of adalimumab Q2W until last dose at Week 28.
• Experimental: Switching Group (Adalimumab - ABP 501)
  Participants will initially receive adalimumab until Week 10 during the lead-in period. Thereafter, starting from Week 12, participants will switch between ABP 501 and adalimumab Q2W with last dose of ABP 501 at Week 28.

Primary Outcome Measure

Area Under the Curve From Time 0 Over the Dosing Interval (AUCtau) of ABP 501 (Switching Group) and Adalimumab (Continued-use Group) [ Time Frame: Week 28 pre-dose and 1hour, 1 day, 3 days, 4 days, 7 days, 11 days, and 14 days post Week 28 dose ]

Locations (35)

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