NCT02660580

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 443 (actual)
• Sponsor: Fresenius Kabi SwissBioSim GmbH · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Psoriasis
• Plaque Type Psoriasis
• Moderate to Severe Plaque Psoriasis

Interventions

Type	Name	Description
DRUG	MSB11022	Participants received MSB11022 drug subcutaneously MSB11022 (Core Treatment Period), MSB11022 (Extended Treatment Period) and EU-Humira/MSB11022 arm.
DRUG	Humira®	Participants received EU-Humira subcutaneously in EU-Humira, EU-Humira/EU-Humira and EU-Humira/MSB11022 arm.

Timeline

• Start date: 2016-02-16
• Primary completion: 2016-12-31
• Completion: 2017-12-18
• First posted: 2016-01-21
• Last updated: 2023-12-27
• Results posted: 2019-02-19

Locations

76 sites across 12 countries: United States, Bulgaria, Canada, Czechia, Estonia, France, Germany, Hungary, Mexico, Poland, Russia, United Kingdom