Study to Demonstrate Equivalent Efficacy and to Compare Safety of Biosimilar Adalimumab (GP2017) and Humira

• Status: Completed
• Trial end date: 2016-02-01
• Target enrollment: 0
• Participant gender: All

Summary

The aim of the study is to demonstrate equivalent efficacy and similarity in the safety profile of GP2017 and Humira® in patients with moderate to severe chronic plaque-type psoriasis.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sandoz
• Collaborator: Hexal AG
• Treatments: Adalimumab

Criteria

Inclusion Criteria:

• Men or women at least 18 years of age at time of screening

• Chronic plaque-type psoriasis diagnosed for at least 6 months before randomization

• Moderate to severe psoriasis as defined at baseline by:

• PASI score of 12 or greater

• Investigator´s Global Assessment score of 3 or greater (based on a scale of 0 - 4) and,

• Body Surface Area affected by plaque-type psoriasis of 10% or greater

• Chronic plaque-type psoriasis patients who have previously received phototherapy or systemic psoriasis therapy at least once or who are candidates for such therapies in the opinion of the investigator.

Exclusion Criteria:

• Forms of psoriasis other than chronic plaque-type

• Drug-induced psoriasis

• Ongoing use of prohibited psoriasis treatments

• Previous exposure to adalimumab

• Active ongoing inflammatory diseases other than psoriasis that might confound the evaluation of the benefit of treatment with adalimumab

Other In-/Exclusion criteria may apply