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

Completed · Phase 3

Conditions studied: Plaque Type Psoriasis

In brief

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.

Key facts

Study ID

NCT02016105

Run by

Sandoz

People needed

465

Starts

2013-12-01

Expected to finish

2016-02-01

Last updated by the study team

2017-05-30

Who can join

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

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• Alliance Dermatology & MOHS Center, PC — Phoenix, Arizona, United States
• Burke Pharmaceutical Research — Hot Springs, Arkansas, United States
• Anaheim Clinical Trials — Anaheim, California, United States
• Bakersfield Dermatology and Skin Cancer Medical Group — Bakersfield, California, United States
• Wallace Medical Group — Beverly Hills, California, United States
• California Dermatology & Clinical Research Institute — Encinitas, California, United States
• Dr. Howard Sofen — Los Angeles, California, United States
• Southern California Permanente Medical Group — Los Angeles, California, United States
• Palmtree Clinical Research — Rancho Mirage, California, United States
• Medical Center For Clinical Research — San Diego, California, United States
• Therapeutics Clinical Research — San Diego, California, United States
• Clinical Science Institute — Santa Monica, California, United States
• Ventura Clinical Trials — Ventura, California, United States
• Horizons Clinical Research Center, LLC — Denver, Colorado, United States
• Savin Dermatology Center, P.C. — New Haven, Connecticut, United States
• Florida Academic Dermatology Center — Coral Gables, Florida, United States
• Florida Medical Center & Research Inc — Miami, Florida, United States
• Renstar Medical Research — Ocala, Florida, United States
• Psoriasis Treatment Center of South Florida — Pembroke Pines, Florida, United States
• McIlwain Medical Group, PA — Tampa, Florida, United States
• MedPhase, Inc. — Newnan, Georgia, United States
• Pharmaceutical Research Organization — Rigby, Idaho, United States
• Dundee Derm. — West Dundee, Illinois, United States
• Dawes Fretzin Clinical Research Group, LLC — Indianapolis, Indiana, United States
• Total Skin & Beauty Dermatology Center — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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