Loading clinical trials...

MSB11022 in Moderate to Severe Chronic Plaque Psoriasis | Clinical Trials | Clareo Health

COMPLETEDPHASE3

MSB11022 in Moderate to Severe Chronic Plaque Psoriasis

A Randomized, Double-blind Trial to Evaluate the Efficacy, Safety and Immunogenicity of MSB11022 Compared With Humira® in Subjects With Moderate to Severe Chronic Plaque Psoriasis

NCT02660580•Fresenius Kabi SwissBioSim GmbH

View on ClinicalTrials.gov

Summary

The purpose of this study was to compare the efficacy, safety and immunogenicity of MSB11022 and Humira® in adult subjects with moderate to severe chronic plaque type psoriasis.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Male or female participants greater than or equal to (\>=) 18 years old with a clinical diagnosis of stable moderate to severe plaque psoriasis (defined by Psoriasis Area and Severity Index \[PASI\] score \>=12, Physician Global Assessment \[PGA\] score \>=3, and \>=10% of body surface area affected at Screening and Baseline \[Day 1 of Week 1\]) who have a history of receipt of or are candidates for systemic therapy or phototherapy for active plaque-type psoriasis despite topical therapy
•Participants must not have received more than 1 biologic therapy

Exclusion Criteria

•Participants was excluded if they have erythrodermic, pustular, guttate, or medication-induced forms of psoriasis or other active skin diseases/infections that may interfere with the evaluation of plaque psoriasis
•Participants must not have received adalimumab or an investigational or licensed biosimilar of adalimumab; topical therapies for the treatment of psoriasis or ultraviolet B phototherapy within 2 weeks of investigational medicinal product (IMP) administration or plan to take such treatment during the trial; or psoralen combined with ultraviolet A phototherapy or nonbiological systemic therapies for psoriasis within 4 weeks prior to IMP administration
•Participants was excluded if they have a history of an ongoing, chronic, or recurrent infectious disease (except for latent tuberculosis \[TB\]); history of active TB; or a history of hypersensitivity to any component of the IMP formulation, comparable drugs, or latex

Locations (76)

San Luis Dermatology & Laser Clinic, Inc.

San Luis Obispo, California, United States

Florida Academic Centers Research and Education

Coral Gables, Florida, United States

Palm Beach Research Center

West Palm Beach, Florida, United States

Dermatology Treatment and Research Center

Dallas, Texas, United States

Modern Research Associates

Dallas, Texas, United States

Dermatology Clinical Research Center of San Antonio

San Antonio, Texas, United States

DCC 'Sveti Georgi' EOOD

Haskovo, Bulgaria

UMHAT 'Dr. Georgi Stranski', EAD

Pleven, Bulgaria

DCC "Sv. Georgi", EOOD

Plovdiv, Bulgaria

Diagnostic Consultative Center II - Sofia OOD

Sofia, Bulgaria

Key Dates

Start Date

February 16, 2016

Primary Completion Date

December 31, 2016

Completion Date

December 18, 2017

Last Updated

December 27, 2023

Enrollment

443

ACTUAL participants

Conditions

PsoriasisPlaque Type PsoriasisModerate to Severe Plaque Psoriasis

Interventions

MSB11022

DRUG

Humira®

DRUG

A Study of Guselkumab After Switching From Ustekinumab in Participants With Moderate to Severe Psoriasis

NCT07449234

Psoriasis

View study

RECRUITINGPHASE3

Long-Term Safety Study of Deucravacitinib Versus Ustekinumab in Participants With Psoriasis (PRAGMATYK)

NCT07116967

Plaque Psoriasis

View study

RECRUITINGPHASE3

A Long-Term Study of Zasocitinib in Children and Teenagers With Plaque Psoriasis

NCT07250802

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 27, 2023Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

MSB11022 in Moderate to Severe Chronic Plaque Psoriasis

Inclusion Criteria

Exclusion Criteria

A Study of Guselkumab After Switching From Ustekinumab in Participants With Moderate to Severe Psoriasis

Long-Term Safety Study of Deucravacitinib Versus Ustekinumab in Participants With Psoriasis (PRAGMATYK)

A Long-Term Study of Zasocitinib in Children and Teenagers With Plaque Psoriasis

An Open-Label Extension Study of ORKA-001 in Participants With Plaque Psoriasis

Dose Ranging Study of ORKA-001 in Patients With Moderate-to-Severe Plaque Psoriasis

Real-Life Evaluation of Guselkumab Dosing Interval Adjustments