Adalimumab Phase 3 Trial for Plaque Psoriasis Completes Primary Period

A Phase 3 clinical trial evaluating adalimumab for the treatment of plaque psoriasis completed its primary endpoint period on March 31, 2025. The study, identified as NCT06005532, is designed to compare the efficacy, safety, and immunogenicity of adalimumab (manufactured by Mabscale, LLC) against Humira®.

Background

The trial, officially titled "Study Evaluation of the Efficacy, Safety and Immunogenicity of Adalimumab in Comparison With Humira®," focuses on adult patients with chronic plaque psoriasis of moderate and severe degree. Adalimumab is a well-established treatment for various inflammatory conditions, including plaque psoriasis. This particular study aims to demonstrate the comparability of a new adalimumab product to the reference product, Humira®.

Trial design

The MABPS-3/2020 study (NCT06005532) is a Phase 3, double-blind, randomized, multicenter clinical trial. It enrolled 494 participants diagnosed with plaque psoriasis. The primary objective of the study is to compare the efficacy, immunogenicity, and safety profiles of adalimumab (manufactured by Mabscale, LLC) with those of Humira®. Participants were randomized to receive either adalimumab or Humira®. The completion of the primary endpoint period signifies that all participants have completed the initial treatment and observation phase relevant to the study's main objectives.

What this means

The completion of the primary endpoint period for this Phase 3 trial is a significant milestone in the development of this adalimumab product. It indicates that the core data collection for assessing the primary outcomes has concluded. The next steps will involve data analysis to evaluate the comparative efficacy, safety, and immunogenicity of the investigational adalimumab against Humira®. The findings from this trial will be crucial for determining the potential for this adalimumab product to provide an alternative treatment option for patients with plaque psoriasis, potentially increasing access and affordability.

Source

Information regarding the primary completion of trial NCT06005532, "Study Evaluation of the Efficacy, Safety and Immunogenicity of Adalimumab in Comparison With Humira®," was obtained from ClinicalTrials.gov. The event date for primary completion was March 31, 2025, as recorded on clinicaltrials.gov.