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

NCT02016105 | Completed Phase 3 Results DMC

• 2 other identifiers: GP17-3012013-000747-11
• Study Type: interventional
• Target: 465
• Locations: 4 countries
• Sites: 79

Brief 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.

Conditions

Plaque Type Psoriasis

Keywords

plaque type psoriasis; equivalent efficacy; safety and immunogenicity; GP2017; Humira®

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (13)

• 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 Arms (2)

GP2017 Adalimumab

EXPERIMENTAL

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

Humira ® Adalimumab

ACTIVE COMPARATOR

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

Interventions

GP2017 Adalimumab DRUG

GP2017 Adalimumab

Humira ® Adalimumab DRUG

Humira ® Adalimumab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Sandoz: lead
• Hexal AG: collaborator

Study Sites (79)

Total Skin & Beauty Dermatology Center

Birmingham, Alabama, United States

Location

Alliance Dermatology & MOHS Center, PC

Phoenix, Arizona, 85032, United States

Location

Burke Pharmaceutical Research

Hot Springs, Arkansas, United States

Location

Anaheim Clinical Trials

Anaheim, California, United States

Location

Bakersfield Dermatology and Skin Cancer Medical Group

Bakersfield, California, United States

Location

Wallace Medical Group

Beverly Hills, California, 90211, United States

Location

California Dermatology & Clinical Research Institute

Encinitas, California, 92024, United States

Location

Dr. Howard Sofen

Los Angeles, California, United States

Location

Southern California Permanente Medical Group

Los Angeles, California, United States

Location

Palmtree Clinical Research

Rancho Mirage, California, 92270, United States

Location

Medical Center For Clinical Research

San Diego, California, United States

Location

Therapeutics Clinical Research

San Diego, California, United States

Location

Clinical Science Institute

Santa Monica, California, 90404, United States

Location

Ventura Clinical Trials

Ventura, California, 93003, United States

Location

Horizons Clinical Research Center, LLC

Denver, Colorado, 80220, United States

Location

Savin Dermatology Center, P.C.

New Haven, Connecticut, United States

Location

Florida Academic Dermatology Center

Coral Gables, Florida, United States

Location

Florida Medical Center & Research Inc

Miami, Florida, United States

Location

Renstar Medical Research

Ocala, Florida, 34471, United States

Location

Psoriasis Treatment Center of South Florida

Pembroke Pines, Florida, 33028, United States

Location

McIlwain Medical Group, PA

Tampa, Florida, 33613, United States

Location

MedPhase, Inc.

Newnan, Georgia, 30263, United States

Location

Pharmaceutical Research Organization

Rigby, Idaho, United States

Location

Dundee Derm.

West Dundee, Illinois, United States

Location

Dawes Fretzin Clinical Research Group, LLC

Indianapolis, Indiana, 46256, United States

Location

The Dermatology Center, PSC

New Albany, Indiana, 47150, United States

Location

The Indiana Clinical Trials Center

Plainfield, Indiana, United States

Location

Dermatology Specialists Research, LLC

Louisville, Kentucky, 40202, United States

Location

DermResearch, PLLC

Louisville, Kentucky, United States

Location

Pedia Research, LLC

Owensboro, Kentucky, United States

Location

Medical Development Centers, LLC

Baton Rouge, Louisiana, 70808, United States

Location

Dermat. & Adv. Aesthetics

Lake Charles, Louisiana, United States

Location

Clinical Trials of America, Inc.

Monroe, Louisiana, United States

Location

Bay State Clinical Trials, Inc.

Watertown, Massachusetts, United States

Location

Great Lakes Research Group, Inc.

Bay City, Michigan, 48706, United States

Location

Somerset Skin Centre

Troy, Michigan, United States

Location

Associated Skin Care Specs

Fridley, Minnesota, United States

Location

MediSearch Clinical Trials

Saint Joseph, Missouri, United States

Location

Central Dermatology

St Louis, Missouri, 63117, United States

Location

The Clinical Research Center, L.L.C.

St Louis, Missouri, United States

Location

J. Woodson Dermatology & Associates

Henderson, Nevada, United States

Location

Las Vegas Skin and Cancer Clinic

Las Vegas, Nevada, 89128, United States

Location

Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, 03756, United States

Location

Buffalo Medical Group, P.C.

Buffalo, New York, United States

Location

Forest Hills Dermatology Group

Forest Hills, New York, 11375, United States

Location

New York University Medical

Lake Success, New York, 11041, United States

Location

DermResearch Center of New York

Stony Brook, New York, United States

Location

PMG Research of Charlotte, LLC

Charlotte, North Carolina, United States

Location

Wake Research Associates, LLC

Raleigh, North Carolina, 27612, United States

Location

Wilmington Dermatology Center

Wilmington, North Carolina, 28403, United States

Location

PMG Research of Winston-Salem, LLC

Winston-Salem, North Carolina, United States

Location

Ohio State University Clinical Trials Management Office

Columbus, Ohio, United States

Location

Lynn Health Science Institute

Oklahoma City, Oklahoma, 73112, United States

Location

Corvallis Clinic PC

Corvallis, Oregon, 97330, United States

Location

Oregon Dermatology and Research Center

Portland, Oregon, 97210, United States

Location

Oregon Medical Research Center, P.C.

Portland, Oregon, 97223, United States

Location

University of Pittsburgh Medical Center Health System

Pittsburgh, Pennsylvania, 15213, United States

Location

Clinical Partners, LLC

Johnston, Rhode Island, United States

Location

Radiant Research, Inc.

Greer, South Carolina, United States

Location

Health Concepts

Rapid City, South Dakota, United States

Location

PMG Research of Bristol, LLC

Bristol, Tennessee, 37620, United States

Location

Austin Dermatology Associates

Austin, Texas, 78705, United States

Location

Menter Dermatology Research Institute

Dallas, Texas, United States

Location

Modern Research Associates

Dallas, Texas, United States

Location

Stephen Miller MD

San Antonio, Texas, 78249, United States

Location

Center for Clinical Studies

Webster, Texas, United States

Location

Advanced Research Institute

Ogden, Utah, United States

Location

Premier Clinical Research

Spokane, Washington, United States

Location

Mountain State Clinical Research

Clarksburg, West Virginia, United States

Location

UMHAT Dr. Georgi Stranski, EAD

Pleven, Bulgaria

Location

Center for Skin and Venereal Diseases EOOD Sofia

Sofia, Bulgaria

Location

UMHAT "Alexandrovska", EAD

Sofia, Bulgaria

Location

Diagnostic-consulting center 3-Varna EOOD

Varna, Bulgaria

Location

Hopital de l'Archet 2

Nice, France

Location

Hôpital Charles Nicolle

Rouen, France

Location

Kozne oddelenie,Nemocnica Kosice-Saca a.s.,1. sukromna nemoc

Kosice-Saca, Slovakia

Location

Pedi-Derma s.r.o., Dermatovenerologicka ambulancia

Košice, Slovakia

Location

SANARE s.r.o. Dermatovenerologická ambulancia

Svidník, 08901, Slovakia

Location

SANARE s.r.o.

Svidník, Slovakia

Location

Related Publications (2)

• 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.

  PMID: 39545451 DERIVED

• 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.

  PMID: 33651341 DERIVED

Limitations and Caveats

none reported

Results Point of Contact

• Title: Global Program Medical Director
• Organization: Sandoz

biopharma.clinicaltrials@sandoz.com

+49 8024 476

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 14, 2013
• First Posted: December 19, 2013
• Study Start: December 1, 2013
• Primary Completion: July 1, 2015
• Study Completion: February 1, 2016
• Last Updated: May 30, 2017
• Results First Posted: April 7, 2017

Record last verified: 2017-04

Locations

SL (4); US (69); FR (2); BU (4)