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

Plaque Type Psoriasis Clinical Trial

— ADACCESS  

Official title:

A Randomized, Double-blind, Multicenter Study to Demonstrate Equivalent Efficacy and to Compare Safety and Immunogenicity of a Biosimilar Adalimumab (GP2017) and Humira® in Patients With Moderate to Severe Chronic Plaque-type Psoriasis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02016105
• Other study ID #: GP17-301
• Secondary ID: 2013-000747-11
• Status: Completed
• Phase: Phase 3
• First received: December 14, 2013
• Last updated: September 1, 2016
• Start date: December 2013
• Est. completion date: February 2016

Study information

• Verified date: September 2016
• Source: Sandoz
• Contact: n/a
• Is FDA regulated: No
• Health authority: Bulgaria: Bulgarian Drug AgencyGermany: Paul-Ehrlich-InstitutHungary: National Institute for Quality and Organizational Development in Healthcare and MedicinesPoland: Office for Registration of Medicinal Products, Medical Devices and Biocidal ProductsRomania: National Agency for Medicines and Medical DevicesRussia: Ministry of Health of the Russian FederationSlovakia: State Institute for Drug ControlUnited States: Food and Drug AdministrationIndia: Ministry of HealthFrance: Agence Nationale de Sécurité du Médicament et des produits de santéSpain: Spanish Agency of Medicines
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 465
• Est. completion date: February 2016
• Est. primary completion date: July 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Plaque Type Psoriasis
• Psoriasis

Intervention

Drug:
• GP2017 Adalimumab

• Humira ® Adalimumab

Locations

Country	Name	City	State
Bulgaria	UMHAT Dr. Georgi Stranski, EAD	Pleven
Bulgaria	Center for Skin and Venereal Diseases EOOD Sofia	Sofia
Bulgaria	UMHAT "Alexandrovska", EAD	Sofia
Bulgaria	Diagnostic-consulting center 3-Varna EOOD	Varna
France	Hopital de l'Archet 2	Nice Cedex 3
France	Hôpital Charles Nicolle	Rouen
Slovakia	Pedi-Derma s.r.o., Dermatovenerologicka ambulancia	Kosice
Slovakia	Kozne oddelenie,Nemocnica Kosice-Saca a.s.,1. sukromna nemoc	Kosice-Saca
Slovakia	SANARE s.r.o.	Svidnik
Slovakia	SANARE s.r.o. Dermatovenerologická ambulancia	Svidník
United States	Anaheim Clinical Trials	Anaheim	California
United States	Austin Dermatology Associates	Austin	Texas
United States	Bakersfield Dermatology and Skin Cancer Medical Group	Bakersfield	California
United States	Medical Development Centers, LLC	Baton Rouge	Louisiana
United States	Great Lakes Research Group, Inc.	Bay City	Michigan
United States	Wallace Medical Group	Beverly Hills	California
United States	Total Skin & Beauty Dermatology Center	Birmingham	Alabama
United States	PMG Research of Bristol, LLC	Bristol	Tennessee
United States	Buffalo Medical Group, P.C.	Buffalo	New York
United States	PMG Research of Charlotte, LLC	Charlotte	North Carolina
United States	Mountain State Clinical Research	Clarksburg	West Virginia
United States	Ohio State University Clinical Trials Management Office	Columbus	Ohio
United States	Florida Academic Dermatology Center	Coral Gables	Florida
United States	Corvallis Clinic PC	Corvallis	Oregon
United States	Menter Dermatology Research Institute	Dallas	Texas
United States	Modern Research Associates	Dallas	Texas
United States	Horizons Clinical Research Center, LLC	Denver	Colorado
United States	California Dermatology & Clinical Research Institute	Encinitas	California
United States	Forest Hills Dermatology Group	Forest Hills	New York
United States	Associated Skin Care Specs	Fridley	Minnesota
United States	Radiant Research, Inc.	Greer	South Carolina
United States	J. Woodson Dermatology & Associates	Henderson	Nevada
United States	Burke Pharmaceutical Research	Hot Springs	Arkansas
United States	Dawes Fretzin Clinical Research Group, LLC	Indianapolis	Indiana
United States	Clinical Partners, LLC	Johnston	Rhode Island
United States	Dermat. & Adv. Aesthetics	Lake Charles	Louisiana
United States	New York University Medical	Lake Success	New York
United States	Las Vegas Skin and Cancer Clinic	Las Vegas	Nevada
United States	Dartmouth-Hitchcock Medical Center	Lebanon	New Hampshire
United States	Dr. Howard Sofen	Los Angeles	California
United States	Southern California Permanente Medical Group	Los Angeles	California
United States	Dermatology Specialists Research, LLC	Louisville	Kentucky
United States	DermResearch, PLLC	Louisville	Kentucky
United States	Florida Medical Center & Research Inc	Miami	Florida
United States	Clinical Trials of America, Inc.	Monroe	Louisiana
United States	The Dermatology Center, PSC	New Albany	Indiana
United States	Savin Dermatology Center, P.C.	New Haven	Connecticut
United States	MedPhase, Inc.	Newnan	Georgia
United States	Renstar Medical Research	Ocala	Florida
United States	Advanced Research Institute	Ogden	Utah
United States	Lynn Health Science Institute	Oklahoma City	Oklahoma
United States	Pedia Research, LLC	Owensboro	Kentucky
United States	Psoriasis Treatment Center of South Florida	Pembroke Pines	Florida
United States	Alliance Dermatology & MOHS Center, PC	Phoenix	Arizona
United States	University of Pittsburgh Medical Center Health System	Pittsburgh	Pennsylvania
United States	The Indiana Clinical Trials Center	Plainfield	Indiana
United States	Oregon Dermatology and Research Center	Portland	Oregon
United States	Oregon Medical Research Center, P.C.	Portland	Oregon
United States	Wake Research Associates, LLC	Raleigh	North Carolina
United States	Palmtree Clinical Research	Rancho Mirage	California
United States	Health Concepts	Rapid City	South Dakota
United States	Pharmaceutical Research Organization	Rigby	Idaho
United States	Stephen Miller MD	San Antonio	Texas
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	Premier Clinical Research	Spokane	Washington
United States	MediSearch Clinical Trials	St. Joseph	Missouri
United States	Central Dermatology	St. Louis	Missouri
United States	The Clinical Research Center, L.L.C.	St. Louis	Missouri
United States	DermResearch Center of New York	Stony Brook	New York
United States	McIlwain Medical Group, PA	Tampa	Florida
United States	Somerset Skin Centre	Troy	Michigan
United States	Ventura Clinical Trials	Ventura	California
United States	Bay State Clinical Trials, Inc.	Watertown	Massachusetts
United States	Center for Clinical Studies	Webster	Texas
United States	Dundee Derm.	West Dundee	Illinois
United States	Wilmington Dermatology Center	Wilmington	North Carolina
United States	PMG Research of Winston-Salem, LLC	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Sandoz

Countries where clinical trial is conducted

United States,  Bulgaria,  France,  Slovakia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The primary outcome measure is the PASI 75 response rate		Week 16	No
Secondary	PASI response rates	PASI 50, 75, 90 and 100 will be assessed	periodically through 51 weeks	No
Secondary	Change from baseline in IGA		periodically through 51 weeks	No
Secondary	Patient's health related quality of life (HRQoL)		periodically through 51 weeks	No