Clinical trial NCT02016105: Study to Demonstrate Equivalent Efficacy and to Compare Safety of Biosimilar Adalimumab (GP2017) and Humira
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Plaque Type Psoriasis
Keywords: plaque type psoriasis
equivalent efficacy
safety and immunogenicity
GP2017
Humira®
Lead sponsor: Sandoz
Sponsor class: INDUSTRY
Collaborators: name: Hexal AG
First posted: 2013-12-19
Enrollment: 465
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: PASI 75 Response Rate at Week 16 - GP2017 Adalimumab vs Humira ® Adalimumab
timeFrame: At Week 16 only
Secondary outcomes:
measure: Mean Percent Change From Baseline in PASI Score up to Week 16 (MMRM)
timeFrame: Baseline to Week 16
measure: Mean ATE of Percent Change From Baseline in PASI Score up to Week 16 (ANCOVA)
timeFrame: Baseline to Week 16
measure: PASI 50, PASI 75, PASI 90 and PASI 100 Response Rates
timeFrame: At Week 17 only
measure: PASI 50, PASI75, PASI 90 and PASI100 Response Rates
timeFrame: At Week 35 only
measure: PASI 50, PASI75, PASI 90 and PASI100 Response Rates
timeFrame: At Week 51 only
measure: IGA Response Rate
timeFrame: At Week 17 only
measure: IGA Response Rate
timeFrame: At Week 35 only
measure: IGA Response Rate
timeFrame: At Week 51 only
measure: DLQI
timeFrame: At Week 17 only
measure: DLQI
timeFrame: At Week 35 only
measure: DLQI
timeFrame: At Week 51 only
measure: ADA Formation Against GP2017 Adalimumab and Humira® Adalimumab From Randomization Until Week 17
timeFrame: At Week 17 only
measure: ADA Formation Against GP2017 Adalimumab and Humira® Adalimumab From Randomization Until Week 51
timeFrame: At Week 51 only
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Total Skin & Beauty Dermatology Center
state: Alabama
city: Phoenix
country: United States
facility: Alliance Dermatology & MOHS Center, PC
state: Arizona
city: Hot Springs
country: United States
facility: Burke Pharmaceutical Research
state: Arkansas
city: Anaheim
country: United States
facility: Anaheim Clinical Trials
state: California
city: Bakersfield
country: United States
facility: Bakersfield Dermatology and Skin Cancer Medical Group
state: California
city: Beverly Hills
country: United States
facility: Wallace Medical Group
state: California
city: Encinitas
country: United States
facility: California Dermatology & Clinical Research Institute
state: California
city: Los Angeles
country: United States
facility: Dr. Howard Sofen
state: California
city: Los Angeles
country: United States
facility: Southern California Permanente Medical Group
state: California
city: Rancho Mirage
country: United States
facility: Palmtree Clinical Research
state: California
city: San Diego
country: United States
facility: Medical Center For Clinical Research
state: California
city: San Diego
country: United States
facility: Therapeutics Clinical Research
state: California
city: Santa Monica
country: United States
facility: Clinical Science Institute
state: California
city: Ventura
country: United States
facility: Ventura Clinical Trials
state: California
city: Denver
country: United States
facility: Horizons Clinical Research Center, LLC
state: Colorado
city: New Haven
country: United States
facility: Savin Dermatology Center, P.C.
state: Connecticut
city: Coral Gables
country: United States
facility: Florida Academic Dermatology Center
state: Florida
city: Miami
country: United States
facility: Florida Medical Center & Research Inc
state: Florida
city: Ocala
country: United States
facility: Renstar Medical Research
state: Florida
city: Pembroke Pines
country: United States
facility: Psoriasis Treatment Center of South Florida
state: Florida
city: Tampa
country: United States
facility: McIlwain Medical Group, PA
state: Florida
city: Newnan
country: United States
facility: MedPhase, Inc.
state: Georgia
city: Rigby
country: United States
facility: Pharmaceutical Research Organization
state: Idaho
city: West Dundee
country: United States
facility: Dundee Derm.
state: Illinois
city: Indianapolis
country: United States
facility: Dawes Fretzin Clinical Research Group, LLC
state: Indiana
city: New Albany
country: United States
facility: The Dermatology Center, PSC
state: Indiana
city: Plainfield
country: United States
facility: The Indiana Clinical Trials Center
state: Indiana
city: Louisville
country: United States
facility: Dermatology Specialists Research, LLC
state: Kentucky
city: Louisville
country: United States
facility: DermResearch, PLLC
state: Kentucky
city: Owensboro
country: United States
facility: Pedia Research, LLC
state: Kentucky
city: Baton Rouge
country: United States
facility: Medical Development Centers, LLC
state: Louisiana
city: Lake Charles
country: United States
facility: Dermat. & Adv. Aesthetics
state: Louisiana
city: Monroe
country: United States
facility: Clinical Trials of America, Inc.
state: Louisiana
city: Watertown
country: United States
facility: Bay State Clinical Trials, Inc.
state: Massachusetts
city: Bay City
country: United States
facility: Great Lakes Research Group, Inc.
state: Michigan
city: Troy
country: United States
facility: Somerset Skin Centre
state: Michigan
city: Fridley
country: United States
facility: Associated Skin Care Specs
state: Minnesota
city: Saint Joseph
country: United States
facility: MediSearch Clinical Trials
state: Missouri
city: Saint Louis
country: United States
facility: Central Dermatology
state: Missouri
city: Saint Louis
country: United States
facility: The Clinical Research Center, L.L.C.
state: Missouri
city: Henderson
country: United States
facility: J. Woodson Dermatology & Associates
state: Nevada
city: Las Vegas
country: United States
facility: Las Vegas Skin and Cancer Clinic
state: Nevada
city: Lebanon
country: United States
facility: Dartmouth-Hitchcock Medical Center
state: New Hampshire
city: Buffalo
country: United States
facility: Buffalo Medical Group, P.C.
state: New York
city: Forest Hills
country: United States
facility: Forest Hills Dermatology Group
state: New York
city: Lake Success
country: United States
facility: New York University Medical
state: New York
city: Stony Brook
country: United States
facility: DermResearch Center of New York
state: New York
city: Charlotte
country: United States
facility: PMG Research of Charlotte, LLC
state: North Carolina
city: Raleigh
country: United States
facility: Wake Research Associates, LLC
state: North Carolina
city: Wilmington
country: United States
facility: Wilmington Dermatology Center
state: North Carolina
city: Winston-Salem
country: United States
facility: PMG Research of Winston-Salem, LLC
state: North Carolina
city: Columbus
country: United States
facility: Ohio State University Clinical Trials Management Office
state: Ohio
city: Oklahoma City
country: United States
facility: Lynn Health Science Institute
state: Oklahoma
city: Corvallis
country: United States
facility: Corvallis Clinic PC
state: Oregon
city: Portland
country: United States
facility: Oregon Dermatology and Research Center
state: Oregon
city: Portland
country: United States
facility: Oregon Medical Research Center, P.C.
state: Oregon
city: Pittsburgh
country: United States
facility: University of Pittsburgh Medical Center Health System
state: Pennsylvania
city: Johnston
country: United States
facility: Clinical Partners, LLC
state: Rhode Island
city: Greer
country: United States
facility: Radiant Research, Inc.
state: South Carolina
city: Rapid City
country: United States
facility: Health Concepts
state: South Dakota
city: Bristol
country: United States
facility: PMG Research of Bristol, LLC
state: Tennessee
city: Austin
country: United States
facility: Austin Dermatology Associates
state: Texas
city: Dallas
country: United States
facility: Menter Dermatology Research Institute
state: Texas
city: Dallas
country: United States
facility: Modern Research Associates
state: Texas
city: San Antonio
country: United States
facility: Stephen Miller MD
state: Texas
city: Webster
country: United States
facility: Center for Clinical Studies
state: Texas
city: Ogden
country: United States
facility: Advanced Research Institute
state: Utah
city: Spokane
country: United States
facility: Premier Clinical Research
state: Washington
city: Clarksburg
country: United States
facility: Mountain State Clinical Research
state: West Virginia
city: Pleven
country: Bulgaria
facility: UMHAT Dr. Georgi Stranski, EAD
city: Sofia
country: Bulgaria
facility: Center for Skin and Venereal Diseases EOOD Sofia
city: Sofia
country: Bulgaria
facility: UMHAT "Alexandrovska", EAD
city: Varna
country: Bulgaria
facility: Diagnostic-consulting center 3-Varna EOOD
city: Nice Cedex 3
country: France
facility: Hopital de l'Archet 2
city: Rouen
country: France
facility: Hôpital Charles Nicolle
city: Kosice-Saca
country: Slovakia
facility: Kozne oddelenie,Nemocnica Kosice-Saca a.s.,1. sukromna nemoc
city: Kosice
country: Slovakia
facility: Pedi-Derma s.r.o., Dermatovenerologicka ambulancia
city: Svidnik
country: Slovakia
facility: SANARE s.r.o.
city: Svidník
country: Slovakia
facility: SANARE s.r.o. Dermatovenerologická ambulancia
Study officials:
References:
citation: 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.