MSB11022 in Moderate to Severe Chronic Plaque Psoriasis

Completed · Phase 3

Conditions studied: Psoriasis, Plaque Type Psoriasis, Moderate to Severe Plaque Psoriasis

In brief

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.

Key facts

Study ID

NCT02660580

Run by

Fresenius Kabi SwissBioSim GmbH

People needed

443

Starts

2016-02-16

Expected to finish

2017-12-18

Last updated by the study team

2023-12-27

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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
• Other protocol-defined inclusion criteria could apply

You may not qualify if…

• 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
• Other protocol-defined exclusion criteria could apply

Where it is running

• 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
• MC "Robert Koch", EOOD — Sofia, Bulgaria
• Medical Center "Excelsior", OOD — Sofia, Bulgaria
• DCC "Alexandrovska", EOOD — Sofia, Bulgaria
• UMHAT "Alexandrovska" EAD — Sofia, Bulgaria
• Military Medical Academy - MHAT - Sofia — Sofia, Bulgaria
• MC "Synexus - Sofia", EOOD — Sofia, Bulgaria
• DCC 3 - Varna, EOOD — Varna, Bulgaria
• Stratica Medical — Edmonton, Alberta, Canada
• Dr. Lorne E. Albrecht, Inc. — Surrey, British Columbia, Canada
• Gupta, Aditya K. MD — London, Ontario, Canada
• Lynderm Research Inc. — Markham, Ontario, Canada
• DermEdge Research — Mississauga, Ontario, Canada
• Dr Melinda Gooderham Medicine Professional Corporation — Peterborough, Ontario, Canada
• York Dermatology Center — Richmond Hill, Ontario, Canada
• K. Papp Clinical Research — Waterloo, Ontario, Canada
• San Luis Dermatology & Laser Clinic, Inc. — San Luis Obispo, California, United States

Full record on ClinicalTrials.gov

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