ADACCESS
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
Sponsor study identifier
Secondary identifiers
EUDRACT_NUMBER
interventional
465
4 countries
79
Study Start
December 2013
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
July 2015
Actual (reported)Study Completion
February 2016
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
February 2016
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
December 2013
Date type not reportedThis date has not been verified as actual or estimated.
December 14, 2013
Actual (reported)December 19, 2013
Actual (reported)July 2015
Actual (reported)February 2016
Actual (reported)April 7, 2017
Actual (reported)PASI 75 Response Rate at Week 16 - GP2017 Adalimumab vs Humira ® Adalimumab
The primary variable was the PASI75 response rate at Week 16, defined as the proportion of patients achieving a reduction of 75% or more of the PASI score at Week 16 compared with baseline.
At Week 16 only
Mean Percent Change From Baseline in PASI Score up to Week 16 (MMRM)
Baseline to Week 16
Mean ATE of Percent Change From Baseline in PASI Score up to Week 16 (ANCOVA)
Baseline to Week 16
PASI 50, PASI 75, PASI 90 and PASI 100 Response Rates
At Week 17 only
PASI 50, PASI75, PASI 90 and PASI100 Response Rates
At Week 35 only
PASI 50, PASI75, PASI 90 and PASI100 Response Rates
At Week 51 only
Study arm with intervention being studied in the protocol. Adalimumab Solution for subcutaneous injection with an initial dose of 80 mg s.c. in Week 0, followed by 40 mg s.c. eow, starting at Week 1 and ending at Week 51.
Humira® Adalimumab as a subcutaneous injection with an initial dose of 80 mg s.c. in Week 0, followed by 40 mg s.c. eow, starting at Week 1 and ending at Week 51.
Total Skin & Beauty Dermatology Center
Birmingham, Alabama, United States
Alliance Dermatology & MOHS Center, PC
Phoenix, Arizona, 85032, 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, 90211, United States
California Dermatology & Clinical Research Institute
Betteridge N, Blauvelt A, Edgerton C, Fan J, Guerrieri D, Rose L, Brueckmann I, Wang Q. Comparison of treatment with GP2017 (an adalimumab biosimilar) and reference adalimumab in people with plaque psoriasis: a plain language summary of the ADACCESS trial. Immunotherapy. 2026 Jan;18(1):5-15. doi: 10.1080/1750743X.2026.2624291. Epub 2026 Feb 18.
Lemke L, Blauvelt A, Bruckmann I, Cohen HP, Fan J, Guerrieri D, Horvat M, Poetzl J, Torella C, Wang Q, von Richter O. Comparing anti-drug antibody signal-to-noise ratios to assess immunogenicity and interchangeability in adalimumab biosimilar studies. Expert Opin Biol Ther. 2024 Dec;24(12):1375-1385. doi: 10.1080/14712598.2024.2428299. Epub 2024 Nov 19.
none reported
465 participants (actual enrollment reported by the registry).
First Submitted
December 14, 2013
First Posted
December 19, 2013
Study Start
December 2013
Date type not reportedThis date has not been verified as actual or estimated.
Safety and Efficacy Study of Adalimumab in the Treatment of Plaque Psoriasis
Contact the study team to confirm eligibility.
Encinitas, California, 92024, 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, 92270, 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, 90404, United States
Ventura Clinical Trials
Ventura, California, 93003, United States
Horizons Clinical Research Center, LLC
Denver, Colorado, 80220, 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, 34471, United States
Psoriasis Treatment Center of South Florida
Pembroke Pines, Florida, 33028, United States
McIlwain Medical Group, PA
Tampa, Florida, 33613, United States
MedPhase, Inc.
Newnan, Georgia, 30263, United States
Pharmaceutical Research Organization
Rigby, Idaho, United States
Dundee Derm.
West Dundee, Illinois, United States
Dawes Fretzin Clinical Research Group, LLC
Indianapolis, Indiana, 46256, United States
The Dermatology Center, PSC
New Albany, Indiana, 47150, United States
The Indiana Clinical Trials Center
Plainfield, Indiana, United States
Dermatology Specialists Research, LLC
Louisville, Kentucky, 40202, United States
DermResearch, PLLC
Louisville, Kentucky, United States
Pedia Research, LLC
Owensboro, Kentucky, United States
Medical Development Centers, LLC
Baton Rouge, Louisiana, 70808, United States
Dermat. & Adv. Aesthetics
Lake Charles, Louisiana, United States
Clinical Trials of America, Inc.
Monroe, Louisiana, United States
Bay State Clinical Trials, Inc.
Watertown, Massachusetts, United States
Great Lakes Research Group, Inc.
Bay City, Michigan, 48706, United States
Somerset Skin Centre
Troy, Michigan, United States
Associated Skin Care Specs
Fridley, Minnesota, United States
MediSearch Clinical Trials
Saint Joseph, Missouri, United States
Central Dermatology
St Louis, Missouri, 63117, United States
The Clinical Research Center, L.L.C.
St Louis, Missouri, United States
J. Woodson Dermatology & Associates
Henderson, Nevada, United States
Las Vegas Skin and Cancer Clinic
Las Vegas, Nevada, 89128, United States
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, 03756, United States
Buffalo Medical Group, P.C.
Buffalo, New York, United States
Forest Hills Dermatology Group
Forest Hills, New York, 11375, United States
New York University Medical
Lake Success, New York, 11041, United States
DermResearch Center of New York
Stony Brook, New York, United States
PMG Research of Charlotte, LLC
Charlotte, North Carolina, United States
Wake Research Associates, LLC
Raleigh, North Carolina, 27612, United States
Wilmington Dermatology Center
Wilmington, North Carolina, 28403, United States
PMG Research of Winston-Salem, LLC
Winston-Salem, North Carolina, United States
Ohio State University Clinical Trials Management Office
Columbus, Ohio, United States
Lynn Health Science Institute
Oklahoma City, Oklahoma, 73112, United States
Corvallis Clinic PC
Corvallis, Oregon, 97330, United States
Oregon Dermatology and Research Center
Portland, Oregon, 97210, United States
Oregon Medical Research Center, P.C.
Portland, Oregon, 97223, United States
University of Pittsburgh Medical Center Health System
Pittsburgh, Pennsylvania, 15213, United States
Clinical Partners, LLC
Johnston, Rhode Island, United States
Radiant Research, Inc.
Greer, South Carolina, United States
Health Concepts
Rapid City, South Dakota, United States
PMG Research of Bristol, LLC
Bristol, Tennessee, 37620, United States
Austin Dermatology Associates
Austin, Texas, 78705, United States
Menter Dermatology Research Institute
Dallas, Texas, United States
Modern Research Associates
Dallas, Texas, United States
Stephen Miller MD
San Antonio, Texas, 78249, United States
Center for Clinical Studies
Webster, Texas, United States
Advanced Research Institute
Ogden, Utah, United States
Premier Clinical Research
Spokane, Washington, United States
Mountain State Clinical Research
Clarksburg, West Virginia, United States
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, Bulgaria
Hopital de l'Archet 2
Nice, France
Hôpital Charles Nicolle
Rouen, France
Kozne oddelenie,Nemocnica Kosice-Saca a.s.,1. sukromna nemoc
Kosice-Saca, Slovakia
Pedi-Derma s.r.o., Dermatovenerologicka ambulancia
Košice, Slovakia
SANARE s.r.o. Dermatovenerologická ambulancia
Svidník, 08901, Slovakia
SANARE s.r.o.
Svidník, Slovakia
Blauvelt A, Leonardi CL, Gaylis N, Jauch-Lembach J, Balfour A, Lemke L, Hachaichi S, Brueckmann I, Festini T, Wiland P. Treatment with SDZ-ADL, an Adalimumab Biosimilar, in Patients with Rheumatoid Arthritis, Psoriasis, or Psoriatic Arthritis: Results of Patient-Reported Outcome Measures from Two Phase III Studies (ADMYRA and ADACCESS). BioDrugs. 2021 Mar;35(2):229-238. doi: 10.1007/s40259-021-00470-1. Epub 2021 Mar 2.
Primary Completion
July 2015
Actual (reported)Study Completion
February 2016
Actual (reported)Last Updated
May 30, 2017
Results First Posted
April 7, 2017
Record last verified: 2017-04
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Source: ClinicalTrials.gov.
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