Clinical trial NCT02134210: Comparison of CHS-0214 to Enbrel (Etanercept) in Patients With Chronic Plaque Psoriasis (PsO)
Official title: A Double-Blind, Randomized, Parallel-Group, Active-Control Study to Compare the Efficacy and Safety of CHS-0214 Versus Enbrel in Subjects With Chronic Plaque Psoriasis (RaPsOdy)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Plaque Psoriasis
Keywords: PsO
Lead sponsor: Coherus Biosciences, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Shire
First posted: 2014-05-09
Enrollment: 521
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: This is a two part study comparing CHS-0214 to Enbrel in patients with chronic plaque PsO who have not yet received any biologic therapy for any indication (other than insulin or hormones).

Detailed description: Pt. 1 is a 12-week randomized, double-blind, active-control, parallel-group, multi-center global study. The primary end point is 75% improvement from baseline according to the Psoriasis Area and Severity Index (PASI-75). Comparing CHS-0214 to Enbrel for efficacy and safety at a dosage of 50mg subcutaneous (Sc) twice weekly.

Pt. 2 is a 40-week randomized, double-blind, active-control, parallel-group, multi-center global study where CHS-0214 and Enbrel dosage is reduced to 50mg Sc weekly for maintenance.

Eligibility criteria: Inclusion Criteria:

* Male or female adults
* PsO diagnosis for 6 months
* Active disease: PASI greater than or equal to 12, Physician's Static Global Assessment (PSGA) score greater than or equal to 3 (based on a scale or 0-5),
* Body Surface Area (BSA) involved with PsO greater than or equal to 10%
* Dermatology Life Quality Index (DQLI) greater than or equal to 10
* Previously received phototherapy or systemic non-biologic therapy for PsO

Exclusion Criteria:

* Forms of Psoriasis other than PsO
* Drug induced Psoriasis
* Positive QuantiFERON-tuberculosis (TB) Gold Test
* Presence of significant comorbid conditions
* Chemistry and hematology values outside protocol specified range
* Major systemic infections

Primary outcomes:
measure: Proportion of Subjects Achieving PASI-75(75% Improvement in Psoriasis Area and Severity Index) From Baseline at Week 12
timeFrame: 12-weeks
measure: Mean Percent Change in PASI (Psoriasis Area and Severity Index) at 12 Weeks
timeFrame: 12 Weeks
Secondary outcomes:
measure: Mean Percent Change in PASI (Psoriasis Area and Severity Index) From Baseline
timeFrame: Weeks 4, 8, 12, 24, 36, and 48
measure: Number of Participants Who Achieved PASI - 75 (75% Improvement in Psoriasis Area and Severity Index)
timeFrame: Weeks 4, 8, 12, 24, 36, and 48
measure: Number of Subjects Who Achieved a 50% Improvement in Psoriasis Area and Severity Index (PASI-50) and a 90% Improvement in PASI (PASI-90)
timeFrame: Weeks 4, 8, 12, 24, 36, and 48
measure: Change in PSGA (Physician's Static Global Assessment) of Disease Activity on a Scale of 0 to 5
timeFrame: 4, 8, 12, 24, 36, and 48
measure: The Proportion of Subjects With a Change in a PSGA (Physician's Static Global Assessment) Score = 0 to 1
timeFrame: Weeks 4, 8, 12, 24, 36, and 48
measure: Change in Subject's Global Assessment (SGA) of PsO
timeFrame: Weeks 4, 8, 12, 24, 36, and 48
measure: Change in DLQI (Dermatology Life Quality Index)
timeFrame: Weeks 12, 24, and 48
measure: Change in EuroQol 5-Dimension Health Status Questionnaire (EQ-5D)
timeFrame: Weeks 12, 24, and 48
measure: Change in Health Assessment Questionnaire-Disability Index (HAQ-DI)
timeFrame: Weeks 12, 24, and 48
measure: Change in Highly Sensitive C-reactive Protein (Hs-CRP; mg/L)
timeFrame: Weeks 12, 24, and 48
measure: The Proportion of Subjects With a Durability of Response at Week 48
timeFrame: Weeks 24, 36, and 48 when compared to baseline (Week 0).
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Arizona Research Center
state: Arizona
city: Scottsdale
country: United States
facility: Radiant Research - Scottsdale
state: Arizona
city: Anaheim
country: United States
facility: Anaheim Clinical Trials
state: California
city: Anaheim
country: United States
facility: Dream Team Clinical Research
state: California
city: Encino
country: United States
facility: Private Practice
state: California
city: Los Angeles
country: United States
facility: Kaiser Permanente
state: California
city: San Diego
country: United States
facility: Skin Surgery Medical Group, Inc
state: California
city: Santa Monica
country: United States
facility: Clinical Science Institute
state: California
city: Torrance
country: United States
facility: Healthcare Partners Medical Group
state: California
city: Denver
country: United States
facility: Horizons Clinical Research Center
state: Colorado
city: New Haven
country: United States
facility: The Savin Center
state: Connecticut
city: Trumbull
country: United States
facility: New England Research Associates
state: Connecticut
city: Miami
country: United States
facility: Florida Academic Dermatology Center (U of Miami Hospital)
state: Florida
city: Pinellas Park
country: United States
facility: Radiant Research - Pinellas Park
state: Florida
city: West Palm Beach
country: United States
facility: Atlantic Clinical Research Collaborative
state: Florida
city: West Palm Beach
country: United States
facility: Palm Beach Research Center
state: Florida
city: Atlanta
country: United States
facility: Radiant Research - Atlanta
state: Georgia
city: Atlanta
country: United States
facility: Private Practice - Jamie Weisman
state: Georgia
city: Arlington Heights
country: United States
facility: Altman Dermatology Associates
state: Illinois
city: Springfield
country: United States
facility: Springfield Clinic
state: Illinois
city: Plainfield
country: United States
facility: The Indiana Clinical Trials Center
state: Indiana
city: Overland Park
country: United States
facility: Kansas City Dermatology
state: Kansas
city: Louisville
country: United States
facility: Derm Research
state: Kentucky
city: Fort Gratiot
country: United States
facility: Hamzavi Dermatology Clinical Research
state: Michigan
city: Warren
country: United States
facility: Grekin Skin Institute
state: Michigan
city: Edina
country: United States
facility: Radiant Research - Edina
state: Minnesota
city: Saint Louis
country: United States
facility: Central Dermatology
state: Missouri
city: East Windsor
country: United States
facility: The Psoriasis Treatment Center of Central New Jersey
state: New Jersey
city: Rochester
country: United States
facility: Skin Search of Rochester, Inc
state: New York
city: Stony Brook
country: United States
facility: DermResearch Center of New York
state: New York
city: Cary
country: United States
facility: PMG Research of Carey, LLC
state: North Carolina
city: Charlotte
country: United States
facility: DJL Clinical Research
state: North Carolina
city: Wilmington
country: United States
facility: PMG Research of Wilmington
state: North Carolina
city: Cincinnati
country: United States
facility: Radiant Research
state: Ohio
city: Oklahoma City
country: United States
facility: Health Research of Oklahoma
state: Oklahoma
city: Duncansville
country: United States
facility: Altoona Center for Clincal Research
state: Pennsylvania
city: Wyomissing
country: United States
facility: Clinical Research Center of Reading
state: Pennsylvania
city: Anderson
country: United States
facility: Radiant Research - Anderson
state: South Carolina
city: Charleston
country: United States
facility: Dermatology and Laser Center of Charleston
state: South Carolina
city: Greer
country: United States
facility: Radient Research - Greer
state: South Carolina
city: Goodlettsville
country: United States
facility: Rivergate Dermatology
state: Tennessee
city: Dallas
country: United States
facility: Neighborhood Medical Center
state: Texas
city: Houston
country: United States
facility: Center for Clinical Studies
state: Texas
city: Houston
country: United States
facility: Heights Dermatology and Aesthetic Center
state: Texas
city: San Antonio
country: United States
facility: Progressive Clinical Research - San Antonio
state: Texas
city: Webster
country: United States
facility: Center for Clinical Studies
state: Texas
city: Seattle
country: United States
facility: Dermatology Associates, PLLC
state: Washington
city: Spokane
country: United States
facility: Premier Clinical Research
state: Washington
city: Wenatchee
country: United States
facility: Wenatchee Valley Hospital and Clinics
state: Washington
city: Clarksburg
country: United States
facility: Mountain State Clinical Research
state: West Virginia
city: Phillip
country: Australia
facility: Woden Dermatology Pty
state: Australian Capital Territory
city: Kogarah
country: Australia
facility: Dr S P Shumack (St George Dermatology and Skin Cancer Center)
state: New South Wales
city: Sydney
country: Australia
facility: Dr S P Shumack (Central Sydney Dermatology)
state: New South Wales
city: Hectorville
country: Australia
facility: North Eastern Health Specialists
state: South Australia
city: East Melbourne
country: Australia
facility: Sinclair Dermatology
state: Victoria
city: Calgary
country: Canada
facility: E and D Woolner Professional Corporation
state: Alberta
city: Calgary
country: Canada
facility: Institute for Skin Advancement Inc
state: Alberta
city: Ajax
country: Canada
facility: CCA Medical Research Corporation
state: Ontario
city: Markham
country: Canada
facility: Lynderm Research Inc
state: Ontario
city: North Bay
country: Canada
facility: North Bay Dermatology Centre Inc
state: Ontario
city: Oakville
country: Canada
facility: Institute of Cosmetic and Laser Surgery
state: Ontario
city: Peterborough
country: Canada
facility: SKiN Center for Dermatology
state: Ontario
city: Richmond Hill
country: Canada
facility: Private Practice
state: Ontario
city: Toronto
country: Canada
facility: Research Toronto
state: Ontario
city: Waterloo
country: Canada
facility: K. Papp Clinical Research Inc
state: Ontario
city: Berlin
country: Germany
facility: MVZ Reichenberger Str., Aerztehaus "Rudolf Virchow
city: Dresden
country: Germany
facility: Klinische Forschung Dresden GmbH
city: Erlangen
country: Germany
facility: Hautklinik Universitaetsklinikum Erlangen
city: Frankfurt
country: Germany
facility: Johann Wolfgang Hospital - Goethe University
city: Hamburg
country: Germany
facility: Dermatologikum Hamburg
city: Luebeck
country: Germany
facility: University Hospital Schleswig-Holstein - Campus Luebeck
city: Afula
country: Israel
facility: Haemek Medical Center
city: Haifa
country: Israel
facility: Rambam Health Care Campus
city: Petah Tikva
country: Israel
facility: Rabin Medical Center Beilinson Campus
city: Tel Aviv
country: Israel
facility: Tel Aviv Sourasky Medical Center
city: Bialystok
country: Poland
facility: NZOZ Osteo-Medic s.c. Artur Racewicz, Jerzy Supronik
city: Bialystok
country: Poland
facility: Niepubliczny Zaklad Opieki Zdrowotnej Centrum Osteoporozy i Chorób Kostno-Stawowych J. Badurski S.J
city: Gdansk
country: Poland
facility: Centrum Badan Klinicznych PI-House Sp. Z o.o
city: Gdynia
country: Poland
facility: Synexus Polska Sp. z o.o. Oddzial w Gdyni
city: Katowice
country: Poland
facility: Synexus Polska Sp. z o.o. Oddzial w Katowicach
city: Krakow
country: Poland
facility: Specjalistyczny Osrodek ALL-MED
city: Krakow
country: Poland
facility: Krakowskie Centrum Medyczne
city: Krakow
country: Poland
facility: Center Med
city: Lodz
country: Poland
facility: Specjalistyczne Gabinety Lekarskie "Dermed
city: Poznan
country: Poland
facility: Centrum Medyczne SYNEXUS POZNAN
city: Rzeszow
country: Poland
facility: Centrum Medyczne Medyk
city: Stalowa Wola
country: Poland
facility: SANUS Szpital Specjalistyczny Sp. z o.o
city: Szczecin
country: Poland
facility: EuroMedis Sp. z o.o.
city: Torun
country: Poland
facility: NZOZ "Nasz Lekarz" Praktyka Grupowa Lekarzy z Przychodnia Specjalistyczna
city: Warszawa
country: Poland
facility: Synexus Polska Sp. z o.o. Oddzial w Warszawie
city: Warszawa
country: Poland
facility: MTZ Clinical Research Sp. z o.o.
city: Wroclaw
country: Poland
facility: Synexus Polska sp. z o.o
city: Wroclaw
country: Poland
facility: Dermmedica Sp. z o.o
city: Pinelands
country: South Africa
facility: Vincent Pallotti Hospital
state: Cape Town
city: Rondebosch
country: South Africa
facility: Synopsis Research
state: Cape Town
city: Pretoria West
country: South Africa
facility: Jongaie Research
state: Pretoria
city: Somerset West
country: South Africa
facility: Helderberg Clinical Trial Centre
state: Western Cape
city: Cape Town
country: South Africa
facility: Dr IC Louw
city: Stellenbosch
country: South Africa
facility: Winelands Rheumatology Centre
city: Worcester
country: South Africa
facility: Clinical Projects Research
Study officials:
affiliation: Coherus Biosciences, Inc.
name: Barbara K Finck, M.D.
role: STUDY_DIRECTOR
References: