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Trial record 2 of 3 for:    psoriasis coherus

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02134210
Recruitment Status : Completed
First Posted : May 9, 2014
Results First Posted : May 13, 2019
Last Update Posted : June 28, 2019
Sponsor:
Collaborator:
Shire
Information provided by (Responsible Party):
Coherus Biosciences, Inc.

Tracking Information
First Submitted Date  ICMJE May 7, 2014
First Posted Date  ICMJE May 9, 2014
Results First Submitted Date  ICMJE December 13, 2018
Results First Posted Date  ICMJE May 13, 2019
Last Update Posted Date June 28, 2019
Actual Study Start Date  ICMJE June 16, 2014
Actual Primary Completion Date July 27, 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 6, 2019)
  • Proportion of Subjects Achieving PASI-75(75% Improvement in Psoriasis Area and Severity Index) From Baseline at Week 12 [ Time Frame: 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 [ Time Frame: 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.
Original Primary Outcome Measures  ICMJE
 (submitted: May 8, 2014)
PASI-75 [ Time Frame: 12 Weeks ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 7, 2019)
  • Mean Percent Change in PASI (Psoriasis Area and Severity Index) From Baseline [ Time Frame: Weeks 4, 8, 12, 24, 36, and 48 ]
    Mean percent change in PASI from baseline at Weeks 4, 8, 12, 24, 36, and 48
  • Number of Participants Who Achieved PASI - 75 (75% Improvement in Psoriasis Area and Severity Index) [ Time Frame: 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.
  • Number of Subjects Who Achieved a 50% Improvement in Psoriasis Area and Severity Index (PASI-50) and a 90% Improvement in PASI (PASI-90) [ Time Frame: 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 PSGA (Physician's Static Global Assessment) of Disease Activity on a Scale of 0 to 5 [ Time Frame: 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.
  • The Proportion of Subjects With a Change in a PSGA (Physician's Static Global Assessment) Score = 0 to 1 [ Time Frame: 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.
  • Change in Subject's Global Assessment (SGA) of PsO [ Time Frame: 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.
  • Change in DLQI (Dermatology Life Quality Index) [ Time Frame: 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.
  • Change in EuroQol 5-Dimension Health Status Questionnaire (EQ-5D) [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: 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.
  • The Proportion of Subjects With a Durability of Response at Week 48 [ Time Frame: 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).
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Comparison of CHS-0214 to Enbrel (Etanercept) in Patients With Chronic Plaque Psoriasis (PsO)
Official Title  ICMJE 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)
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Plaque Psoriasis
Intervention  ICMJE
  • Drug: Etanercept
    Head-to-head comparison
    Other Names:
    • Enbrel
    • European Enbrel
  • Drug: CHS-0214
Study Arms  ICMJE
  • Active Comparator: Enbrel (etanercept)
    Enbrel 50mg twice weekly times 12 weeks
    Intervention: Drug: Etanercept
  • Experimental: CHS-0214
    CHS-0214 50mg twice weekly times 12 weeks
    Intervention: Drug: CHS-0214
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 24, 2016)
521
Original Estimated Enrollment  ICMJE
 (submitted: May 8, 2014)
424
Actual Study Completion Date  ICMJE May 12, 2016
Actual Primary Completion Date July 27, 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Australia,   Canada,   Germany,   Israel,   Poland,   South Africa,   United States
Removed Location Countries United Kingdom
 
Administrative Information
NCT Number  ICMJE NCT02134210
Other Study ID Numbers  ICMJE CHS-0214-04
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Coherus Biosciences, Inc.
Study Sponsor  ICMJE Coherus Biosciences, Inc.
Collaborators  ICMJE Shire
Investigators  ICMJE
Study Director: Barbara K Finck, M.D. Coherus Biosciences, Inc.
PRS Account Coherus Biosciences, Inc.
Verification Date June 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP