NCT06005532

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

Randomized Double Blind Phase III Trial Comparative Clinical Safety, Efficacy and Immunogenicity of Adalimumab (Manufactured by Mabscale, LLC) to Humira®.

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 494 (estimated)
• Sponsor: Mabscale, LLC · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Adalimumab is a recombinant humanized monoclonal antibody currently being developed by Mabscale LLC, as a proposed biosimilar to Humira®, which is approved as treatment in patients with chronic plaque psoriasis. This randomized equivalence study is designed to meet the regulatory requirement for approval of a biosimilar product.

Conditions

• Plaque Psoriasis

Interventions

Type	Name	Description
DRUG	Adalimumab	Adalimumab injection 40 mg / 0.8 ml
DRUG	Humira	Adalimumab injection 40 mg / 0.4 ml

Timeline

• Start date: 2023-10-02
• Primary completion: 2025-03-01
• Completion: 2025-12-01
• First posted: 2023-08-22
• Last updated: 2023-11-29

Locations

9 sites across 1 country: Russia