NCT05073315

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

A Multicenter, Randomized, Double-blind Study Evaluating the Pharmacokinetics, Efficacy, Safety, and Immunogenicity of Multiple Switches Between Humira® (Adalimumab [US]) and ABP 501 Compared With Continued Use of Adalimumab in Subjects With Moderate to Severe Plaque Psoriasis

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 425 (actual)
• Sponsor: Amgen · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Plaque Psoriasis

Interventions

Type	Name	Description
DRUG	Adalimumab	Participants will receive subcutaneous (SC) injection of adalimumab
DRUG	ABP 501	Participants will receive SC injection of ABP 501

Timeline

• Start date: 2021-10-04
• Primary completion: 2022-12-19
• Completion: 2022-12-19
• First posted: 2021-10-11
• Last updated: 2024-02-09
• Results posted: 2024-02-09

Locations

88 sites across 6 countries: United States, Canada, Estonia, Germany, Latvia, Poland

Regulatory

• FDA-regulated drug study