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

NCT06005532 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 494

Last updated 2023-11-29

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Adalimumab

Adalimumab injection 40 mg / 0.8 ml

DRUG

Humira

Adalimumab injection 40 mg / 0.4 ml

Sponsors & Collaborators

  • Mabscale, LLC

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-10-02
Primary Completion
2025-03-31
Completion
2025-12-31

Countries

  • Russia

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06005532 on ClinicalTrials.gov