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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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)

Conditions
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Plaque Psoriasis

Intervention / Treatment
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* Drug: Etanercept
* Drug: CHS-0214


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Enbrel (etanercept)<br>Enbrel 50mg twice weekly times 12 weeks | Drug: Etanercept<br>* Head-to-head comparison<br>* Other names: European Enbrel;|
| Experimental: CHS-0214<br>CHS-0214 50mg twice weekly times 12 weeks | Drug: CHS-0214<br> <br> |

What is the study measuring?
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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). | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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PsO