Comparison of CHS-0214 to Enbrel (Etanercept) in Patients With Chronic Plaque Psoriasis (PsO)
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)
1 other identifier
interventional
521
7 countries
100
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Jun 2014
100 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 7, 2014
CompletedFirst Posted
Study publicly available on registry
May 9, 2014
CompletedStudy Start
First participant enrolled
June 16, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 27, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
May 12, 2016
CompletedResults Posted
Study results publicly available
May 13, 2019
CompletedJune 28, 2019
June 1, 2019
1.1 years
May 7, 2014
December 13, 2018
June 7, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Proportion of Subjects Achieving PASI-75(75% Improvement in Psoriasis Area and Severity Index) From Baseline at Week 12
The Psoriasis Area and Severity Index (PASI) is well established in the medical literature and is internationally the most widely used instrument to assess the severity of Psoriasis. Proportion of subjects achieving PASI-75 from baseline at Week 12. This was the primary endpoint supporting a Biologics Licensing Application in the US.
12-weeks
Mean Percent Change in PASI (Psoriasis Area and Severity Index) at 12 Weeks
Mean percent changed in PASI from baseline (last non-missing value prior to first dose) at Week 12. This was the primary endpoint supporting the Marketing Authorization Application in the EU.
12 Weeks
Secondary Outcomes (11)
Mean Percent Change in PASI (Psoriasis Area and Severity Index) From Baseline
Weeks 4, 8, 12, 24, 36, and 48
Number of Participants Who Achieved PASI - 75 (75% Improvement in Psoriasis Area and Severity Index)
Weeks 4, 8, 12, 24, 36, and 48
Number of Subjects Who Achieved a 50% Improvement in Psoriasis Area and Severity Index (PASI-50) and a 90% Improvement in PASI (PASI-90)
Weeks 4, 8, 12, 24, 36, and 48
Change in PSGA (Physician's Static Global Assessment) of Disease Activity on a Scale of 0 to 5
4, 8, 12, 24, 36, and 48
The Proportion of Subjects With a Change in a PSGA (Physician's Static Global Assessment) Score = 0 to 1
Weeks 4, 8, 12, 24, 36, and 48
- +6 more secondary outcomes
Study Arms (2)
Enbrel (etanercept)
ACTIVE COMPARATOREnbrel 50mg twice weekly times 12 weeks
CHS-0214
EXPERIMENTALCHS-0214 50mg twice weekly times 12 weeks
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Coherus Oncology, Inc.lead
- Shirecollaborator
Study Sites (100)
Arizona Research Center
Phoenix, Arizona, 85020, United States
Radiant Research - Scottsdale
Scottsdale, Arizona, 85251, United States
Anaheim Clinical Trials
Anaheim, California, 92801, United States
Dream Team Clinical Research
Anaheim, California, 92801, United States
Private Practice
Encino, California, 91436, United States
Kaiser Permanente
Los Angeles, California, 90027, United States
Skin Surgery Medical Group, Inc
San Diego, California, 92117, United States
Clinical Science Institute
Santa Monica, California, 90404, United States
Healthcare Partners Medical Group
Torrance, California, 90503, United States
Horizons Clinical Research Center
Denver, Colorado, 80220, United States
The Savin Center
New Haven, Connecticut, 06511, United States
New England Research Associates
Trumbull, Connecticut, 06611, United States
Florida Academic Dermatology Center (U of Miami Hospital)
Miami, Florida, 33136, United States
Radiant Research - Pinellas Park
Pinellas Park, Florida, 33781, United States
Atlantic Clinical Research Collaborative
West Palm Beach, Florida, 33406, United States
Palm Beach Research Center
West Palm Beach, Florida, 33409, United States
Radiant Research - Atlanta
Atlanta, Georgia, 30328, United States
Private Practice - Jamie Weisman
Atlanta, Georgia, 30342, United States
Altman Dermatology Associates
Arlington Heights, Illinois, 60005, United States
Springfield Clinic
Springfield, Illinois, 62703, United States
The Indiana Clinical Trials Center
Plainfield, Indiana, 46168, United States
Kansas City Dermatology
Overland Park, Kansas, 66215, United States
Derm Research
Louisville, Kentucky, 40217, United States
Hamzavi Dermatology Clinical Research
Fort Gratiot, Michigan, 48059, United States
Grekin Skin Institute
Warren, Michigan, 48093, United States
Radiant Research - Edina
Edina, Minnesota, 55435, United States
Central Dermatology
St Louis, Missouri, 63117, United States
The Psoriasis Treatment Center of Central New Jersey
East Windsor, New Jersey, 08520, United States
Skin Search of Rochester, Inc
Rochester, New York, 14623, United States
DermResearch Center of New York
Stony Brook, New York, 11790, United States
PMG Research of Carey, LLC
Cary, North Carolina, 27518, United States
DJL Clinical Research
Charlotte, North Carolina, 28210, United States
PMG Research of Wilmington
Wilmington, North Carolina, 28401, United States
Radiant Research
Cincinnati, Ohio, 45249, United States
Health Research of Oklahoma
Oklahoma City, Oklahoma, 73103, United States
Altoona Center for Clincal Research
Duncansville, Pennsylvania, 16635, United States
Clinical Research Center of Reading
Wyomissing, Pennsylvania, 19610, United States
Radiant Research - Anderson
Anderson, South Carolina, 29621, United States
Dermatology and Laser Center of Charleston
Charleston, South Carolina, 29414, United States
Radient Research - Greer
Greer, South Carolina, 29650, United States
Rivergate Dermatology
Goodlettsville, Tennessee, 37072, United States
Neighborhood Medical Center
Dallas, Texas, 75254, United States
Center for Clinical Studies
Houston, Texas, 72004, United States
Heights Dermatology and Aesthetic Center
Houston, Texas, 77008, United States
Progressive Clinical Research - San Antonio
San Antonio, Texas, 78229, United States
Center for Clinical Studies
Webster, Texas, 77598, United States
Dermatology Associates, PLLC
Seattle, Washington, 98101, United States
Premier Clinical Research
Spokane, Washington, 99204, United States
Wenatchee Valley Hospital and Clinics
Wenatchee, Washington, 98801, United States
Mountain State Clinical Research
Clarksburg, West Virginia, 26301, United States
Woden Dermatology Pty
Phillip, Australian Capital Territory, 2606, Australia
Dr S P Shumack (St George Dermatology and Skin Cancer Center)
Kogarah, New South Wales, 2217, Australia
Dr S P Shumack (Central Sydney Dermatology)
Sydney, New South Wales, 2000, Australia
North Eastern Health Specialists
Hectorville, South Australia, 5073, Australia
Sinclair Dermatology
East Melbourne, Victoria, 3002, Australia
E and D Woolner Professional Corporation
Calgary, Alberta, Canada
Institute for Skin Advancement Inc
Calgary, Alberta, Canada
CCA Medical Research Corporation
Ajax, Ontario, Canada
Lynderm Research Inc
Markham, Ontario, Canada
North Bay Dermatology Centre Inc
North Bay, Ontario, Canada
Institute of Cosmetic and Laser Surgery
Oakville, Ontario, Canada
SKiN Center for Dermatology
Peterborough, Ontario, Canada
Private Practice
Richmond Hill, Ontario, Canada
Research Toronto
Toronto, Ontario, Canada
K. Papp Clinical Research Inc
Waterloo, Ontario, Canada
MVZ Reichenberger Str., Aerztehaus "Rudolf Virchow
Berlin, 13055, Germany
Klinische Forschung Dresden GmbH
Dresden, 01069, Germany
Hautklinik Universitaetsklinikum Erlangen
Erlangen, 91054, Germany
Johann Wolfgang Hospital - Goethe University
Frankfurt, 60590, Germany
Dermatologikum Hamburg
Hamburg, 20354, Germany
University Hospital Schleswig-Holstein - Campus Luebeck
Lübeck, 23538, Germany
Haemek Medical Center
Afula, 18101, Israel
Rambam Health Care Campus
Haifa, 31096, Israel
Rabin Medical Center Beilinson Campus
Petah Tikva, 49100, Israel
Tel Aviv Sourasky Medical Center
Tel Aviv, 64239, Israel
NZOZ Osteo-Medic s.c. Artur Racewicz, Jerzy Supronik
Bialystok, 15540, Poland
Niepubliczny Zaklad Opieki Zdrowotnej Centrum Osteoporozy i Chorób Kostno-Stawowych J. Badurski S.J
Bialystok, 15879, Poland
Centrum Badan Klinicznych PI-House Sp. Z o.o
Gdansk, 80546, Poland
Synexus Polska Sp. z o.o. Oddzial w Gdyni
Gdynia, 81384, Poland
Synexus Polska Sp. z o.o. Oddzial w Katowicach
Katowice, 40040, Poland
Specjalistyczny Osrodek ALL-MED
Krakow, 31023, Poland
Krakowskie Centrum Medyczne
Krakow, 31501, Poland
Center Med
Krakow, 31530, Poland
Specjalistyczne Gabinety Lekarskie "Dermed
Lodz, 90265, Poland
Centrum Medyczne SYNEXUS POZNAN
Poznan, 60702, Poland
Centrum Medyczne Medyk
Rzeszów, 35055, Poland
SANUS Szpital Specjalistyczny Sp. z o.o
Stalowa Wola, 37450, Poland
EuroMedis Sp. z o.o.
Szczecin, 70111, Poland
NZOZ "Nasz Lekarz" Praktyka Grupowa Lekarzy z Przychodnia Specjalistyczna
Torun, 87100, Poland
Synexus Polska Sp. z o.o. Oddzial w Warszawie
Warsaw, 01192, Poland
MTZ Clinical Research Sp. z o.o.
Warsaw, 02106, Poland
Synexus Polska sp. z o.o
Wroclaw, 50088, Poland
Dermmedica Sp. z o.o
Wroclaw, 51318, Poland
Vincent Pallotti Hospital
Pinelands, Cape Town, 7405, South Africa
Synopsis Research
Rondebosch, Cape Town, 7700, South Africa
Jongaie Research
Pretoria West, Pretoria, 0183, South Africa
Helderberg Clinical Trial Centre
Somerset West, Western Cape, 7130, South Africa
Dr IC Louw
Cape Town, 7500, South Africa
Winelands Rheumatology Centre
Stellenbosch, South Africa
Clinical Projects Research
Worcester, 6850, South Africa
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Barbara K. Finck, MD Chief Medical Officer
- Organization
- Coherus BioSciences, Inc
Study Officials
- STUDY DIRECTOR
Barbara K Finck, M.D.
Coherus Oncology, Inc.
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
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
May 7, 2014
First Posted
May 9, 2014
Study Start
June 16, 2014
Primary Completion
July 27, 2015
Study Completion
May 12, 2016
Last Updated
June 28, 2019
Results First Posted
May 13, 2019
Record last verified: 2019-06