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

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.

Study Overview

• Status: Completed
• Conditions: Plaque Type Psoriasis
• Intervention / Treatment: Drug: GP2017 Adalimumab; Drug: Humira ® Adalimumab

Detailed Description

The aim of this study (Treatment Period 1) was to demonstrate equivalent efficacy, primarily based on the PASI75 response rate at Week 16, and similar safety of the proposed biosimilar GP2017 and Humira in patients with moderate to severe chronic plaque-type psoriasis at the end of Treatment Period 1, after 17 weeks of study treatment.

The subsequent Treatment Period 2 (Week 17 to Week 35) and the Extension Period (Week 35 to Week 51) were performed to evaluate long-term effects, including immunogenicity (i.e. ADAs), and the effects of repeated switching between GP2017 and Humira.

• Study Type: Interventional
• Enrollment (Actual): 465
• Phase: Phase 3

Contacts and Locations

Study Locations

• Bulgaria
  • Pleven, Bulgaria
    • UMHAT Dr. Georgi Stranski, EAD
  • Sofia, Bulgaria
    • Center for Skin and Venereal Diseases EOOD Sofia
  • Sofia, Bulgaria
    • UMHAT "Alexandrovska", EAD
  • Varna, Bulgaria
    • Diagnostic-consulting center 3-Varna EOOD
• France
  • Nice Cedex 3, France
    • Hopital de l'archet 2
  • Rouen, France
    • Hopital Charles Nicolle
• Slovakia
  • Kosice, Slovakia
    • Pedi-Derma s.r.o., Dermatovenerologicka ambulancia
  • Kosice-Saca, Slovakia
    • Kozne oddelenie,Nemocnica Kosice-Saca a.s.,1. sukromna nemoc
  • Svidnik, Slovakia
    • SANARE s.r.o.
  • Svidník, Slovakia, 08901
    • SANARE s.r.o. Dermatovenerologická ambulancia
• United States
  • Alabama
    • Birmingham, Alabama, United States
      • Total Skin & Beauty Dermatology Center
  • Arizona
    • Phoenix, Arizona, United States, 85032
      • Alliance Dermatology & MOHS Center, PC
  • Arkansas
    • Hot Springs, Arkansas, United States
      • Burke Pharmaceutical Research
  • California
    • Anaheim, California, United States
      • Anaheim Clinical Trials
    • Bakersfield, California, United States
      • Bakersfield Dermatology and Skin Cancer Medical Group
    • Beverly Hills, California, United States, 90211
      • Wallace Medical Group
    • Encinitas, California, United States, 92024
      • California Dermatology & Clinical Research Institute
    • Los Angeles, California, United States
      • Dr. Howard Sofen
    • Los Angeles, California, United States
      • Southern California Permanente Medical Group
    • Rancho Mirage, California, United States, 92270
      • Palmtree Clinical Research
    • San Diego, California, United States
      • Medical Center for Clinical Research
    • San Diego, California, United States
      • Therapeutics Clinical Research
    • Santa Monica, California, United States, 90404
      • Clinical Science Institute
    • Ventura, California, United States, 93003
      • Ventura Clinical Trials
  • Colorado
    • Denver, Colorado, United States, 80220
      • Horizons Clinical Research Center, LLC
  • Connecticut
    • New Haven, Connecticut, United States
      • Savin Dermatology Center, P.C.
  • Florida
    • Coral Gables, Florida, United States
      • Florida Academic Dermatology Center
    • Miami, Florida, United States
      • Florida Medical Center & Research Inc
    • Ocala, Florida, United States, 34471
      • Renstar Medical Research
    • Pembroke Pines, Florida, United States, 33028
      • Psoriasis Treatment Center of South Florida
    • Tampa, Florida, United States, 33613
      • McIlwain Medical Group, PA
  • Georgia
    • Newnan, Georgia, United States, 30263
      • MedPhase, Inc.
  • Idaho
    • Rigby, Idaho, United States
      • Pharmaceutical Research Organization
  • Illinois
    • West Dundee, Illinois, United States
      • Dundee Derm.
  • Indiana
    • Indianapolis, Indiana, United States, 46256
      • Dawes Fretzin Clinical Research Group, LLC
    • New Albany, Indiana, United States, 47150
      • The Dermatology Center, PSC
    • Plainfield, Indiana, United States
      • The Indiana Clinical Trials Center
  • Kentucky
    • Louisville, Kentucky, United States, 40202
      • Dermatology Specialists Research, LLC
    • Louisville, Kentucky, United States
      • DermResearch, PLLC
    • Owensboro, Kentucky, United States
      • Pedia Research, LLC
  • Louisiana
    • Baton Rouge, Louisiana, United States, 70808
      • Medical Development Centers, LLC
    • Lake Charles, Louisiana, United States
      • Dermat. & Adv. Aesthetics
    • Monroe, Louisiana, United States
      • Clinical Trials of America, Inc.
  • Massachusetts
    • Watertown, Massachusetts, United States
      • Bay State Clinical Trials, Inc.
  • Michigan
    • Bay City, Michigan, United States, 48706
      • Great Lakes Research Group, Inc.
    • Troy, Michigan, United States
      • Somerset Skin Centre
  • Minnesota
    • Fridley, Minnesota, United States
      • Associated Skin Care Specs
  • Missouri
    • Saint Joseph, Missouri, United States
      • Medisearch Clinical Trials
    • Saint Louis, Missouri, United States, 63117
      • Central Dermatology
    • Saint Louis, Missouri, United States
      • The Clinical Research Center, L.L.C.
  • Nevada
    • Henderson, Nevada, United States
      • J. Woodson Dermatology & Associates
    • Las Vegas, Nevada, United States, 89128
      • Las Vegas Skin and Cancer Clinic
  • New Hampshire
    • Lebanon, New Hampshire, United States, 03756
      • Dartmouth-Hitchcock Medical Center
  • New York
    • Buffalo, New York, United States
      • Buffalo Medical Group, P.C.
    • Forest Hills, New York, United States, 11375
      • Forest Hills Dermatology Group
    • Lake Success, New York, United States, 11041
      • New York University Medical
    • Stony Brook, New York, United States
      • DermResearch Center of New York
  • North Carolina
    • Charlotte, North Carolina, United States
      • PMG Research of Charlotte, LLC
    • Raleigh, North Carolina, United States, 27612
      • Wake Research Associates, LLC
    • Wilmington, North Carolina, United States, 28403
      • Wilmington Dermatology Center
    • Winston-Salem, North Carolina, United States
      • PMG Research of Winston-Salem, LLC
  • Ohio
    • Columbus, Ohio, United States
      • Ohio State University Clinical Trials Management Office
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73112
      • Lynn Health Science Institute
  • Oregon
    • Corvallis, Oregon, United States, 97330
      • Corvallis Clinic PC
    • Portland, Oregon, United States, 97210
      • Oregon Dermatology and Research Center
    • Portland, Oregon, United States, 97223
      • Oregon Medical Research Center, P.C.
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15213
      • University of Pittsburgh Medical Center Health System
  • Rhode Island
    • Johnston, Rhode Island, United States
      • Clinical Partners, LLC
  • South Carolina
    • Greer, South Carolina, United States
      • Radiant Research, Inc.
  • South Dakota
    • Rapid City, South Dakota, United States
      • Health Concepts
  • Tennessee
    • Bristol, Tennessee, United States, 37620
      • PMG Research of Bristol, LLC
  • Texas
    • Austin, Texas, United States, 78705
      • Austin Dermatology Associates
    • Dallas, Texas, United States
      • Menter Dermatology Research Institute
    • Dallas, Texas, United States
      • Modern Research Associates
    • San Antonio, Texas, United States, 78249
      • Stephen Miller MD
    • Webster, Texas, United States
      • Center For Clinical Studies
  • Utah
    • Ogden, Utah, United States
      • Advanced Research Institute
  • Washington
    • Spokane, Washington, United States
      • Premier Clinical Research
  • West Virginia
    • Clarksburg, West Virginia, United States
      • Mountain State Clinical Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: GP2017 Adalimumab; 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.	Drug: GP2017 Adalimumab
Active Comparator: Humira ® Adalimumab; 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.	Drug: Humira ® Adalimumab

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean Percent Change From Baseline in PASI Score up to Week 16 (MMRM)	The key secondary efficacy variable was the percentage change from baseline in PASI score at each visit up to Week 16.	Baseline to Week 16
Mean ATE of Percent Change From Baseline in PASI Score up to Week 16 (ANCOVA)	The key secondary efficacy variable was the average treatment effect (ATE) which is the weighted average of % change from baseline in PASI scores between Week 1 and Week 16 (weights based on the time interval between two consecutive visits).	Baseline to Week 16
PASI 50, PASI 75, PASI 90 and PASI 100 Response Rates	Proportion of patients achieving PASI 50, 75, 90 and 100 at Week 17 (end of Treatment Period 1)	At Week 17 only
PASI 50, PASI75, PASI 90 and PASI100 Response Rates	Proportion of Patients Achieving PASI 50, 75, 90 and 100 at Week 35 (end of Treatment Period 2)	At Week 35 only
PASI 50, PASI75, PASI 90 and PASI100 Response Rates	Proportion of Patients Achieving PASI 50, 75, 90 and 100 at Week 51 (Entire Study)	At Week 51 only
IGA Response Rate	Proportion of patients achieving a score of 0 ("clear") or 1 ("almost clear") or improved by at least 2 points of the IGA scale compared to baseline at Week 17.	At Week 17 only
IGA Response Rate	Proportion of patients achieving a score of 0 ("clear") or 1 ("almost clear") or improved by at least 2 points of the IGA scale compared to baseline at Week 51	At Week 35 only
IGA Response Rate	Proportion of patients achieving a score of 0 ("clear") or 1 ("almost clear") or improved by at least 2 points of the IGA scale compared to baseline at Week 51	At Week 51 only
DLQI	Proportion of patients reporting a DLQI of 0 or 1 (no effect at all on patient's life)	At Week 17 only
DLQI	Proportion of patients reporting a DLQI of 0 or 1 (no effect at all on patient's life)	At Week 35 only
DLQI	Proportion of patients reporting a DLQI of 0 or 1 (no effect at all on patient's life)	At Week 51 only
ADA Formation Against GP2017 Adalimumab and Humira® Adalimumab From Randomization Until Week 17	Proportion of patients with at least one confirmed positive anti-drug antibodies (ADA) response to adalimumab from Randomization to Week 17. Patients with ADA positive results at baseline were excluded from subsequent results.	At Week 17 only
ADA Formation Against GP2017 Adalimumab and Humira® Adalimumab From Randomization Until Week 51	Proportion of patients with at least one confirmed positive anti-drug antibodies (ADA) response to adalimumab from Randomization to Week 51. Patients with ADA positive results at baseline were excluded from subsequent results.	At Week 51 only

Collaborators and Investigators

• Sponsor: Sandoz
• Collaborators: Hexal AG

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: December 1, 2013
• Primary Completion (Actual): July 1, 2015
• Study Completion (Actual): February 1, 2016

Study Registration Dates

• First Submitted: December 14, 2013
• First Submitted That Met QC Criteria: December 14, 2013
• First Posted (Estimate): December 19, 2013

Study Record Updates

• Last Update Posted (Actual): May 30, 2017
• Last Update Submitted That Met QC Criteria: April 24, 2017
• Last Verified: April 1, 2017

More Information

Terms related to this study

• Keywords: Humira®; plaque type psoriasis; equivalent efficacy; safety and immunogenicity; GP2017
• Additional Relevant MeSH Terms: Skin Diseases; Skin Diseases, Papulosquamous; Psoriasis; Anti-Inflammatory Agents; Antirheumatic Agents; Adalimumab
• Other Study ID Numbers: GP17-301; 2013-000747-11 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided