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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®.
Mabscale, LLC·Phase 3·ClinicalTrials.gov·drugNot yet recruiting
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Study focus
Disease/Condition
Plaque Psoriasis
Drug/Device/Intervention
Adalimumab
Study type
Interventional
Intervention type
drug
Sponsor & location
Primary sponsor
Mabscale, LLC
Location
Barnaul,Chelyabinsk,Kazan',Moscow,Moscow,Nizhny Novgorod,Novosibirsk,Pyatigorsk,Saint Petersburg, Russian Federation
Timeline & enrollment
Phase
Phase 3
Start date
Oct 01, 2023
End date
Dec 01, 2025
Enrollment
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
PsoriasisLarge plaque parapsoriasisOther psoriasisSmall plaque parapsoriasisArthropathic psoriasis
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT06005532
Type
Non-Device Trial
About this record

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.

This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.