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

Plaque Psoriasis Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02134210
• Other study ID #: CHS-0214-04
• Status: Completed
• Phase: Phase 3
• Start date: June 16, 2014
• Est. completion date: May 12, 2016

Study information

• Verified date: June 2019
• Source: Coherus Biosciences, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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 information / eligibility

• Status: Completed
• Enrollment: 521
• Est. completion date: May 12, 2016
• Est. primary completion date: July 27, 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Plaque Psoriasis
• Psoriasis

Intervention

Drug:
• Etanercept
Head-to-head comparison
• CHS-0214

Locations

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

Sponsors (2)

Lead Sponsor	Collaborator
Coherus Biosciences, Inc.	Shire

Countries where clinical trial is conducted

United States,  Australia,  Canada,  Germany,  Israel,  Poland,  South Africa, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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).