drugset / Trial / NCT06005532

Study Evaluation of the Efficacy, Safety and Immunogenicity of Adalimumab in Comparison With Humira®

NCT06005532

Phase 3 Unknown 494 enrolled Mabscale, LLC
RandomizedParallel-groupTriple-blindTreatment

Summary

MABPS-3/2020 is a double-blind randomized multicenter clinical trial comparing efficacy, immunogenicity and safety profiles of Adalimumab (manufactured by Mabscale, LLC) compared to Humira®. The purpose of the study is to demonstrate efficacy, immunogenicity and safety of Adalimumab (manufactured by Mabscale, LLC) to Humira ® in adult patients with chronic plaque psoriasis of moderate and severe degree.

Timeline

Start
2023-10-02
Primary completion
2025-03
Completion
2025-12

Drugs

EvaluationDrugModalityDoseRoute
Comparator Adalimumab Monoclonal antibody 0.4 ml
Comparator Adalimumab Monoclonal antibody 0.8 ml
Comparator Adalimumab Monoclonal antibody 40 mg

Indications