Comparison of CHS-0214 to Enbrel (Etanercept) in Patients With Chronic Plaque Psoriasis (PsO)

Phase 3

Completed

Conditions: Plaque Psoriasis

Interventions: Drug: CHS-0214
Drug: Etanercept

Registration Number: NCT02134210

Lead Sponsor: Coherus Biosciences, Inc.

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 521

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 & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CHS-0214	CHS-0214	CHS-0214 50mg twice weekly times 12 weeks
Enbrel (etanercept)	Etanercept	Enbrel 50mg twice weekly times 12 weeks

Primary Outcome Measures

Name	Time	Method
Proportion of Subjects Achieving PASI-75(75% Improvement in Psoriasis Area and Severity Index) From Baseline at Week 12	12-weeks	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.
Mean Percent Change in PASI (Psoriasis Area and Severity Index) at 12 Weeks	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.

Secondary Outcome Measures

Name	Time	Method
Mean Percent Change in PASI (Psoriasis Area and Severity Index) From Baseline	Weeks 4, 8, 12, 24, 36, and 48	Mean percent change in PASI from baseline at 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	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.
Change in Subject's Global Assessment (SGA) of PsO	Weeks 4, 8, 12, 24, 36, and 48	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.
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	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
Change in DLQI (Dermatology Life Quality Index)	Weeks 12, 24, and 48	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.
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	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.
The Proportion of Subjects With a Durability of Response at Week 48	Weeks 24, 36, and 48 when compared to baseline (Week 0).	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).
Number of Participants Who Achieved PASI - 75 (75% Improvement in Psoriasis Area and Severity Index)	Weeks 4, 8, 12, 24, 36, and 48	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.
Change in EuroQol 5-Dimension Health Status Questionnaire (EQ-5D)	Weeks 12, 24, and 48	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).
Change in Health Assessment Questionnaire-Disability Index (HAQ-DI)	Weeks 12, 24, and 48	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.
Change in Highly Sensitive C-reactive Protein (Hs-CRP; mg/L)	Weeks 12, 24, and 48	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.

Trial Locations

Locations (98): Radiant Research - Atlanta
🇺🇸
Atlanta, Georgia, United States
Healthcare Partners Medical Group
🇺🇸
Torrance, California, United States
Atlantic Clinical Research Collaborative
🇺🇸
West Palm Beach, Florida, United States
Private Practice - Jamie Weisman
🇺🇸
Atlanta, Georgia, United States
Altman Dermatology Associates
🇺🇸
Arlington Heights, Illinois, United States
Horizons Clinical Research Center
🇺🇸
Denver, Colorado, United States
The Savin Center
🇺🇸
New Haven, Connecticut, United States
Derm Research
🇺🇸
Louisville, Kentucky, United States
New England Research Associates
🇺🇸
Trumbull, Connecticut, United States
Palm Beach Research Center
🇺🇸
West Palm Beach, Florida, United States
Grekin Skin Institute
🇺🇸
Warren, Michigan, United States
The Psoriasis Treatment Center of Central New Jersey
🇺🇸
East Windsor, New Jersey, United States
Radiant Research - Anderson
🇺🇸
Anderson, South Carolina, United States
Radient Research - Greer
🇺🇸
Greer, South Carolina, United States
Mountain State Clinical Research
🇺🇸
Clarksburg, West Virginia, United States
Dr S P Shumack (Central Sydney Dermatology)
🇦🇺
Sydney, New South Wales, Australia
Dr S P Shumack (St George Dermatology and Skin Cancer Center)
🇦🇺
Kogarah, New South Wales, Australia
Woden Dermatology Pty
🇦🇺
Phillip, Australian Capital Territory, Australia
E and D Woolner Professional Corporation
🇨🇦
Calgary, Alberta, Canada
CCA Medical Research Corporation
🇨🇦
Ajax, Ontario, Canada
Institute for Skin Advancement Inc
🇨🇦
Calgary, Alberta, Canada
North Bay Dermatology Centre Inc
🇨🇦
North Bay, Ontario, Canada
Institute of Cosmetic and Laser Surgery
🇨🇦
Oakville, Ontario, Canada
K. Papp Clinical Research Inc
🇨🇦
Waterloo, Ontario, Canada
Dermatologikum Hamburg
🇩🇪
Hamburg, Germany
Haemek Medical Center
🇮🇱
Afula, Israel
Rambam Health Care Campus
🇮🇱
Haifa, Israel
NZOZ Osteo-Medic s.c. Artur Racewicz, Jerzy Supronik
🇵🇱
Bialystok, Poland
Synexus Polska Sp. z o.o. Oddzial w Gdyni
🇵🇱
Gdynia, Poland
Specjalistyczny Osrodek ALL-MED
🇵🇱
Krakow, Poland
Specjalistyczne Gabinety Lekarskie "Dermed
🇵🇱
Lodz, Poland
Centrum Medyczne SYNEXUS POZNAN
🇵🇱
Poznan, Poland
SANUS Szpital Specjalistyczny Sp. z o.o
🇵🇱
Stalowa Wola, Poland
EuroMedis Sp. z o.o.
🇵🇱
Szczecin, Poland
MTZ Clinical Research Sp. z o.o.
🇵🇱
Warszawa, Poland
NZOZ "Nasz Lekarz" Praktyka Grupowa Lekarzy z Przychodnia Specjalistyczna
🇵🇱
Torun, Poland
Synexus Polska sp. z o.o
🇵🇱
Wroclaw, Poland
Vincent Pallotti Hospital
🇿🇦
Pinelands, Cape Town, South Africa
Synopsis Research
🇿🇦
Rondebosch, Cape Town, South Africa
Jongaie Research
🇿🇦
Pretoria West, Pretoria, South Africa
Dr IC Louw
🇿🇦
Cape Town, South Africa
Winelands Rheumatology Centre
🇿🇦
Stellenbosch, South Africa
Clinical Projects Research
🇿🇦
Worcester, South Africa
Skin Surgery Medical Group, Inc
🇺🇸
San Diego, California, United States
Florida Academic Dermatology Center (U of Miami Hospital)
🇺🇸
Miami, Florida, United States
Anaheim Clinical Trials
🇺🇸
Anaheim, California, United States
Dream Team Clinical Research
🇺🇸
Anaheim, California, United States
Kaiser Permanente
🇺🇸
Los Angeles, California, United States
Clinical Science Institute
🇺🇸
Santa Monica, California, United States
The Indiana Clinical Trials Center
🇺🇸
Plainfield, Indiana, United States
Springfield Clinic
🇺🇸
Springfield, Illinois, United States
Central Dermatology
🇺🇸
Saint Louis, Missouri, United States
DermResearch Center of New York
🇺🇸
Stony Brook, New York, United States
PMG Research of Carey, LLC
🇺🇸
Cary, North Carolina, United States
Skin Search of Rochester, Inc
🇺🇸
Rochester, New York, United States
DJL Clinical Research
🇺🇸
Charlotte, North Carolina, United States
PMG Research of Wilmington
🇺🇸
Wilmington, North Carolina, United States
Altoona Center for Clincal Research
🇺🇸
Duncansville, Pennsylvania, United States
Neighborhood Medical Center
🇺🇸
Dallas, Texas, United States
Clinical Research Center of Reading
🇺🇸
Wyomissing, Pennsylvania, United States
Center for Clinical Studies
🇺🇸
Webster, Texas, United States
Heights Dermatology and Aesthetic Center
🇺🇸
Houston, Texas, United States
Progressive Clinical Research - San Antonio
🇺🇸
San Antonio, Texas, United States
Dermatology Associates, PLLC
🇺🇸
Seattle, Washington, United States
Wenatchee Valley Hospital and Clinics
🇺🇸
Wenatchee, Washington, United States
Premier Clinical Research
🇺🇸
Spokane, Washington, United States
Kansas City Dermatology
🇺🇸
Overland Park, Kansas, United States
Radiant Research - Edina
🇺🇸
Edina, Minnesota, United States
Radiant Research - Pinellas Park
🇺🇸
Pinellas Park, Florida, United States
Arizona Research Center
🇺🇸
Phoenix, Arizona, United States
Health Research of Oklahoma
🇺🇸
Oklahoma City, Oklahoma, United States
Rivergate Dermatology
🇺🇸
Goodlettsville, Tennessee, United States
Niepubliczny Zaklad Opieki Zdrowotnej Centrum Osteoporozy i Chorób Kostno-Stawowych J. Badurski S.J
🇵🇱
Bialystok, Poland
Synexus Polska Sp. z o.o. Oddzial w Katowicach
🇵🇱
Katowice, Poland
Helderberg Clinical Trial Centre
🇿🇦
Somerset West, Western Cape, South Africa
Research Toronto
🇨🇦
Toronto, Ontario, Canada
University Hospital Schleswig-Holstein - Campus Luebeck
🇩🇪
Luebeck, Germany
Dermmedica Sp. z o.o
🇵🇱
Wroclaw, Poland
Radiant Research - Scottsdale
🇺🇸
Scottsdale, Arizona, United States
Private Practice
🇨🇦
Richmond Hill, Ontario, Canada
Sinclair Dermatology
🇦🇺
East Melbourne, Victoria, Australia
SKiN Center for Dermatology
🇨🇦
Peterborough, Ontario, Canada
Hamzavi Dermatology Clinical Research
🇺🇸
Fort Gratiot, Michigan, United States
Johann Wolfgang Hospital - Goethe University
🇩🇪
Frankfurt, Germany
Rabin Medical Center Beilinson Campus
🇮🇱
Petah Tikva, Israel
Tel Aviv Sourasky Medical Center
🇮🇱
Tel Aviv, Israel
Centrum Badan Klinicznych PI-House Sp. Z o.o
🇵🇱
Gdansk, Poland
Center Med
🇵🇱
Krakow, Poland
Lynderm Research Inc
🇨🇦
Markham, Ontario, Canada
Klinische Forschung Dresden GmbH
🇩🇪
Dresden, Germany
Hautklinik Universitaetsklinikum Erlangen
🇩🇪
Erlangen, Germany
Krakowskie Centrum Medyczne
🇵🇱
Krakow, Poland
Centrum Medyczne Medyk
🇵🇱
Rzeszow, Poland
Synexus Polska Sp. z o.o. Oddzial w Warszawie
🇵🇱
Warszawa, Poland
MVZ Reichenberger Str., Aerztehaus "Rudolf Virchow
🇩🇪
Berlin, Germany
North Eastern Health Specialists
🇦🇺
Hectorville, South Australia, Australia
Dermatology and Laser Center of Charleston
🇺🇸
Charleston, South Carolina, United States
Radiant Research
🇺🇸
Cincinnati, Ohio, United States