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Study Evaluation of the Efficacy, Safety and Immunogenicity of Adalimumab in Comparison With Humira® - Trial NCT06005532

Access comprehensive clinical trial information for NCT06005532 through Pure Global AI's free database. This Phase 3 trial is sponsored by Mabscale, LLC and is currently Not yet recruiting. The study focuses on Plaque Psoriasis. Target enrollment is 494 participants.

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NCT06005532
Phase 3
Not yet recruiting
drug
Trial Details
ClinicalTrials.govNCT06005532
View on ClinicalTrials.gov
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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®.

Study Focus

Plaque Psoriasis

Adalimumab

Interventional

drug

Sponsor & Location

Mabscale, LLC

Barnaul,Chelyabinsk,Kazan',Moscow,Moscow,Nizhny Novgorod,Novosibirsk,Pyatigorsk,Saint Petersburg, Russian Federation

Timeline & Enrollment

Phase 3

Oct 01, 2023

Dec 01, 2025

494 participants

Primary Outcome

The proportion of patients who achieved a response according to the PASI criterion of 75 (a decrease in the severity and prevalence of psoriasis by ≥75% from the baseline level assessed by the PASI index),Proportion of patients with positive antibody titer to Adalimumab,Percentage of patients who have neutralizing antibodies to Adalimumab

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.

ICD-10 Classifications

Psoriasis
Large plaque parapsoriasis
Other psoriasis
Small plaque parapsoriasis
Arthropathic psoriasis

Data Source

ClinicalTrials.gov

NCT06005532

Non-Device Trial