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)

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).

Study Overview

• Status: Completed
• Conditions: Plaque Psoriasis
• Intervention / Treatment: Drug: Etanercept; Drug: CHS-0214

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.

• Study Type: Interventional
• Enrollment (Actual): 521
• Phase: Phase 3

Contacts and Locations

Study Locations

• Australia
  • Australian Capital Territory
    • Phillip, Australian Capital Territory, Australia, 2606
      • Woden Dermatology Pty
  • New South Wales
    • Kogarah, New South Wales, Australia, 2217
      • Dr S P Shumack (St George Dermatology and Skin Cancer Center)
    • Sydney, New South Wales, Australia, 2000
      • Dr S P Shumack (Central Sydney Dermatology)
  • South Australia
    • Hectorville, South Australia, Australia, 5073
      • North Eastern Health Specialists
  • Victoria
    • East Melbourne, Victoria, Australia, 3002
      • Sinclair Dermatology
• Canada
  • Alberta
    • Calgary, Alberta, Canada
      • E and D Woolner Professional Corporation
    • Calgary, Alberta, Canada
      • Institute for Skin Advancement Inc
  • Ontario
    • Ajax, Ontario, Canada
      • CCA Medical Research Corporation
    • Markham, Ontario, Canada
      • Lynderm Research Inc
    • North Bay, Ontario, Canada
      • North Bay Dermatology Centre Inc
    • Oakville, Ontario, Canada
      • Institute of Cosmetic and Laser Surgery
    • Peterborough, Ontario, Canada
      • Skin Center for Dermatology
    • Richmond Hill, Ontario, Canada
      • Private Practice
    • Toronto, Ontario, Canada
      • Research Toronto
    • Waterloo, Ontario, Canada
      • K. Papp Clinical Research Inc
• Germany
  • Berlin, Germany, 13055
    • MVZ Reichenberger Str., Aerztehaus "Rudolf Virchow
  • Dresden, Germany, 01069
    • Klinische Forschung Dresden GmbH
  • Erlangen, Germany, 91054
    • Hautklinik Universitaetsklinikum Erlangen
  • Frankfurt, Germany, 60590
    • Johann Wolfgang Hospital - Goethe University
  • Hamburg, Germany, 20354
    • Dermatologikum Hamburg
  • Luebeck, Germany, 23538
    • University Hospital Schleswig-Holstein - Campus Luebeck
• Israel
  • Afula, Israel, 18101
    • Haemek Medical Center
  • Haifa, Israel, 31096
    • Rambam Health Care Campus
  • Petah Tikva, Israel, 49100
    • Rabin Medical Center Beilinson Campus
  • Tel Aviv, Israel, 64239
    • Tel Aviv Sourasky Medical Center
• Poland
  • Bialystok, Poland, 15540
    • NZOZ OSTEO-MEDIC S.C. Artur Racewicz, Jerzy Supronik
  • Bialystok, Poland, 15879
    • Niepubliczny Zaklad Opieki Zdrowotnej Centrum Osteoporozy i Chorób Kostno-Stawowych J. Badurski S.J
  • Gdansk, Poland, 80546
    • Centrum Badań Klinicznych PI-House sp. z o.o
  • Gdynia, Poland, 81384
    • Synexus Polska Sp. z o.o. Oddzial w Gdyni
  • Katowice, Poland, 40040
    • Synexus Polska Sp. z o.o. Oddzial w Katowicach
  • Krakow, Poland, 31023
    • Specjalistyczny Ośrodek ALL-MED
  • Krakow, Poland, 31501
    • Krakowskie Centrum Medyczne
  • Krakow, Poland, 31530
    • Center Med
  • Lodz, Poland, 90265
    • Specjalistyczne Gabinety Lekarskie "Dermed
  • Poznan, Poland, 60702
    • Centrum Medyczne SYNEXUS POZNAN
  • Rzeszow, Poland, 35055
    • Centrum Medyczne Medyk
  • Stalowa Wola, Poland, 37450
    • SANUS Szpital Specjalistyczny Sp. z o.o
  • Szczecin, Poland, 70111
    • EUROMEDIS Sp. z o.o.
  • Torun, Poland, 87100
    • NZOZ "Nasz Lekarz" Praktyka Grupowa Lekarzy z Przychodnia Specjalistyczna
  • Warszawa, Poland, 01192
    • Synexus Polska Sp. z o.o. Oddzial w Warszawie
  • Warszawa, Poland, 02106
    • MTZ Clinical Research Sp. z o.o.
  • Wroclaw, Poland, 50088
    • Synexus Polska sp. z o.o
  • Wroclaw, Poland, 51318
    • Dermmedica Sp. z o.o
• South Africa
  • Cape Town, South Africa, 7500
    • Dr IC Louw
  • Stellenbosch, South Africa
    • Winelands Rheumatology Centre
  • Worcester, South Africa, 6850
    • Clinical Projects Research
  • Cape Town
    • Pinelands, Cape Town, South Africa, 7405
      • Vincent Pallotti Hospital
    • Rondebosch, Cape Town, South Africa, 7700
      • Synopsis Research
  • Pretoria
    • Pretoria West, Pretoria, South Africa, 0183
      • Jongaie Research
  • Western Cape
    • Somerset West, Western Cape, South Africa, 7130
      • Helderberg Clinical Trial Centre
• United States
  • Arizona
    • Phoenix, Arizona, United States, 85020
      • Arizona Research Center
    • Scottsdale, Arizona, United States, 85251
      • Radiant Research - Scottsdale
  • California
    • Anaheim, California, United States, 92801
      • Anaheim Clinical Trials
    • Anaheim, California, United States, 92801
      • Dream Team Clinical Research
    • Encino, California, United States, 91436
      • Private Practice
    • Los Angeles, California, United States, 90027
      • Kaiser Permanente
    • San Diego, California, United States, 92117
      • Skin Surgery Medical Group, Inc
    • Santa Monica, California, United States, 90404
      • Clinical Science Institute
    • Torrance, California, United States, 90503
      • HealthCare Partners Medical Group
  • Colorado
    • Denver, Colorado, United States, 80220
      • Horizons Clinical Research Center
  • Connecticut
    • New Haven, Connecticut, United States, 06511
      • The Savin Center
    • Trumbull, Connecticut, United States, 06611
      • New England Research Associates
  • Florida
    • Miami, Florida, United States, 33136
      • Florida Academic Dermatology Center (U of Miami Hospital)
    • Pinellas Park, Florida, United States, 33781
      • Radiant Research - Pinellas Park
    • West Palm Beach, Florida, United States, 33409
      • Palm Beach Research Center
    • West Palm Beach, Florida, United States, 33406
      • Atlantic Clinical Research Collaborative
  • Georgia
    • Atlanta, Georgia, United States, 30328
      • Radiant Research - Atlanta
    • Atlanta, Georgia, United States, 30342
      • Private Practice - Jamie Weisman
  • Illinois
    • Arlington Heights, Illinois, United States, 60005
      • Altman Dermatology Associates
    • Springfield, Illinois, United States, 62703
      • Springfield Clinic
  • Indiana
    • Plainfield, Indiana, United States, 46168
      • The Indiana Clinical Trials Center
  • Kansas
    • Overland Park, Kansas, United States, 66215
      • Kansas City Dermatology
  • Kentucky
    • Louisville, Kentucky, United States, 40217
      • Derm Research
  • Michigan
    • Fort Gratiot, Michigan, United States, 48059
      • Hamzavi Dermatology Clinical Research
    • Warren, Michigan, United States, 48093
      • Grekin Skin Institute
  • Minnesota
    • Edina, Minnesota, United States, 55435
      • Radiant Research - Edina
  • Missouri
    • Saint Louis, Missouri, United States, 63117
      • Central Dermatology
  • New Jersey
    • East Windsor, New Jersey, United States, 08520
      • The Psoriasis Treatment Center of Central New Jersey
  • New York
    • Rochester, New York, United States, 14623
      • Skin Search of Rochester, Inc
    • Stony Brook, New York, United States, 11790
      • DermResearch Center of New York
  • North Carolina
    • Cary, North Carolina, United States, 27518
      • PMG Research of Carey, LLC
    • Charlotte, North Carolina, United States, 28210
      • DJL Clinical Research
    • Wilmington, North Carolina, United States, 28401
      • PMG Research of Wilmington
  • Ohio
    • Cincinnati, Ohio, United States, 45249
      • Radiant Research
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73103
      • Health Research of Oklahoma
  • Pennsylvania
    • Duncansville, Pennsylvania, United States, 16635
      • Altoona Center for Clincal Research
    • Wyomissing, Pennsylvania, United States, 19610
      • Clinical Research Center of Reading
  • South Carolina
    • Anderson, South Carolina, United States, 29621
      • Radiant Research - Anderson
    • Charleston, South Carolina, United States, 29414
      • Dermatology and Laser Center of Charleston
    • Greer, South Carolina, United States, 29650
      • Radient Research - Greer
  • Tennessee
    • Goodlettsville, Tennessee, United States, 37072
      • Rivergate Dermatology
  • Texas
    • Dallas, Texas, United States, 75254
      • Neighborhood Medical Center
    • Houston, Texas, United States, 72004
      • Center for Clinical Studies
    • Houston, Texas, United States, 77008
      • Heights Dermatology and Aesthetic Center
    • San Antonio, Texas, United States, 78229
      • Progressive Clinical Research - San Antonio
    • Webster, Texas, United States, 77598
      • Center for Clinical Studies
  • Washington
    • Seattle, Washington, United States, 98101
      • Dermatology Associates, PLLC
    • Spokane, Washington, United States, 99204
      • Premier Clinical Research
    • Wenatchee, Washington, United States, 98801
      • Wenatchee Valley Hospital and Clinics
  • West Virginia
    • Clarksburg, West Virginia, United States, 26301
      • 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:

• 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

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
Active Comparator: Enbrel (etanercept); Enbrel 50mg twice weekly times 12 weeks	Drug: Etanercept; Head-to-head comparison; Other Names: Enbrel; European Enbrel
Experimental: CHS-0214; CHS-0214 50mg twice weekly times 12 weeks	Drug: CHS-0214

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean Percent Change in PASI (Psoriasis Area and Severity Index) From Baseline	Mean percent change in PASI from baseline at Weeks 4, 8, 12, 24, 36, and 48	Weeks 4, 8, 12, 24, 36, and 48
Number of Participants Who Achieved PASI - 75 (75% Improvement in Psoriasis Area and Severity Index)	The proportion of subjects who achieved PASI-75 (75% Improvement in Psoriasis Area and Severity Index) from baseline at Weeks 4, 8, 12, 24, 36, and 48.	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)	The proportion of subjects who achieved a 50% improvement in Psoriasis Area and Severity Index (PASI-50) and a 90% improvement in PASI (PASI-90) response rates from baseline at Weeks 4, 8, 12, 24, 36, and 48	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	Change in PSGA (Physician's Static Global Assessment) of disease activity on a scale of 0 to 5 from baseline to Weeks 4, 8, 12, 24, 36, and 48. Minimum Value: 0 Maximum Value: 5 The PSGA of PsO (Psoriasis) was assessed on a scale of 0 to 5, with 0 indicating no PsO (clear of disease),1 (almost clear), and 2 or higher scores indicating more severe disease. Subjects with a clear (0) or almost clear (1) evaluation were considered PSGA responders.	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	The proportion of subjects with a change in a PSGA (Physician's Static Global Assessment) score = 0 to 1, demonstrating clear or almost clear skin at Weeks 4, 8, 12, 24, 36, and 48; Minimum: 0 Maximum: 1 Subjects with a clear(0) or almost clear(1) evaluation were considered PSGA responders.	Weeks 4, 8, 12, 24, 36, and 48
Change in Subject's Global Assessment (SGA) of PsO	Change in Subject's Global Assessment (SGA) of PsO from baseline to Weeks 4, 8, 12, 24, 36, and 48. The SGA of PsO was assessed using VAS (visual analog scale in the unit of millimeters) , ranging from 0 (good) to 100 (severe). The SGA was assessed at randomization (Week 0/Day 0) and Weeks 4, 8, 12, 24, 36, and 48, as well as at the Follow-up Visit, if applicable. The change in SGA is the value at baseline minus sum of values at weeks 4, 8, 12, 24, 36, and 48. Since the change in SGA is measured from baseline, a negative value indicates a decrease in overall SGA and better overall assessment of PsO.	Weeks 4, 8, 12, 24, 36, and 48
Change in DLQI (Dermatology Life Quality Index)	Change in DLQI (Dermatology Life Quality Index) from baseline to Weeks 12, 24, and 48 The DLQI is a 10-question validated questionnaire that was performed at screening, randomization (Week 0/Day 0), and Weeks 12, 24, and 48. It was calculated by summing the score of each question resulting in a maximum of 30 and a minimum of 0. The higher the score, the more quality of life was impaired.	Weeks 12, 24, and 48
Change in EuroQol 5-Dimension Health Status Questionnaire (EQ-5D)	Change in EuroQol 5-Dimension Health Status Questionnaire (EQ-5D) from baseline to Weeks 12, 24, and 48 The EQ-5D was performed at randomization (Week 0/Day 0), and Weeks 12, 24, and 48. The EQ-5D is a generic (non-disease specific), preference-based health-related quality of life measure based on 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Rated level can be coded as a number 1, 2, or 3, which indicates having no problems for 1, having some problems for 2, and having extreme problems for 3. As a result, a person's health status can be defined by a 5-digit number, ranging from 11111 (having no problems in all dimensions) to 33333 (having extreme problems in all dimensions).	Weeks 12, 24, and 48
Change in Health Assessment Questionnaire-Disability Index (HAQ-DI)	HAQ-DI - Scales for each question range from 0-3 (0=without any difficulty; 1=with some difficulty; 2=with much difficulty; 3=Unable to do). The "total" for each category is determined by the highest score (greatest difficulty) for that category. The score for the disability index is the mean of the eight category scores. If more than 2 of the categories or 25% are missing, the scale won't be scored. If fewer than 2 or the categories are missing, the sum of the categories was divided by the number of answered categories.	Weeks 12, 24, and 48
Change in Highly Sensitive C-reactive Protein (Hs-CRP; mg/L)	Change in highly sensitive C-reactive protein (hs-CRP; mg/L) from baseline to Weeks 12, 24, and 48 for subjects with PsA (Psoriatic arthritis) only. Highly sensitive C-reactive protein For subjects with PsA, change in hs-CRP from baseline to Weeks 12, 24, and 48 was assessed.	Weeks 12, 24, and 48
The Proportion of Subjects With a Durability of Response at Week 48	The proportion of subjects with a durability of response during Part 2. Durability of response was defined as the maintenance of the PASI-50 or greater at Weeks 24, 36, and 48 when compared to baseline (Week 0).	Weeks 24, 36, and 48 when compared to baseline (Week 0).

Collaborators and Investigators

• Sponsor: Coherus Biosciences, Inc.
• Collaborators: Shire
• Investigators: Study Director: Barbara K Finck, M.D., Coherus Biosciences, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): June 16, 2014
• Primary Completion (Actual): July 27, 2015
• Study Completion (Actual): May 12, 2016

Study Registration Dates

• First Submitted: May 7, 2014
• First Submitted That Met QC Criteria: May 8, 2014
• First Posted (Estimate): May 9, 2014

Study Record Updates

• Last Update Posted (Actual): June 28, 2019
• Last Update Submitted That Met QC Criteria: June 7, 2019
• Last Verified: June 1, 2019

More Information

Terms related to this study

• Keywords: PsO
• Additional Relevant MeSH Terms: Skin Diseases; Skin Diseases, Papulosquamous; Psoriasis; Physiological Effects of Drugs; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Immunosuppressive Agents; Immunologic Factors; Gastrointestinal Agents; Etanercept
• Other Study ID Numbers: CHS-0214-04