drugset / Trial / NCT05073315

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

NCT05073315

Phase 3 Completed 425 enrolled Amgen
RandomizedParallel-groupDouble-blindTreatment

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.

Timeline

Start
2021-10-04
Primary completion
2022-12-19
Completion
2022-12-19

Drugs

EvaluationDrugModalityDoseRoute
Subject Adalimumab Monoclonal antibody
Subject Adalimumab Monoclonal antibody Subcutaneous

Indications