Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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.

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).

Condition or disease Intervention/treatment Phase
Plaque Psoriasis Drug: Etanercept Drug: CHS-0214 Phase 3

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.


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 521 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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)
Actual Study Start Date : June 16, 2014
Actual Primary Completion Date : July 27, 2015
Actual Study Completion Date : May 12, 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Psoriasis
Drug Information available for: Etanercept

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



Primary Outcome Measures :
  1. 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.


  2. 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.


Secondary Outcome Measures :
  1. 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

  2. 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.

  3. 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

  4. 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.


  5. 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.


  6. 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.

  7. 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.


  8. 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).


  9. 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.

  10. 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.


  11. 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).



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02134210


  Show 100 Study Locations
Sponsors and Collaborators
Coherus Biosciences, Inc.
Shire
Investigators
Layout table for investigator information
Study Director: Barbara K Finck, M.D. Coherus Biosciences, Inc.

Layout table for additonal information
Responsible Party: Coherus Biosciences, Inc.
ClinicalTrials.gov Identifier: NCT02134210     History of Changes
Other Study ID Numbers: CHS-0214-04
First Posted: May 9, 2014    Key Record Dates
Results First Posted: May 13, 2019
Last Update Posted: June 28, 2019
Last Verified: June 2019
Keywords provided by Coherus Biosciences, Inc.:
PsO
Additional relevant MeSH terms:
Layout table for MeSH terms
Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases
Etanercept
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Gastrointestinal Agents
Immunosuppressive Agents
Immunologic Factors