Study to Demonstrate Equivalent Efficacy and to Compare Safety of Biosimilar Adalimumab (GP2017) and Humira

Study Overview
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Brief Summary
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The aim of the study is to demonstrate equivalent efficacy and similarity in the safety profile of GP2017 and Humira® in patients with moderate to severe chronic plaque-type psoriasis.

Detailed Description
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The aim of this study (Treatment Period 1) was to demonstrate equivalent efficacy, primarily based on the PASI75 response rate at Week 16, and similar safety of the proposed biosimilar GP2017 and Humira in patients with moderate to severe chronic plaque-type psoriasis at the end of Treatment Period 1, after 17 weeks of study treatment. The subsequent Treatment Period 2 (Week 17 to Week 35) and the Extension Period (Week 35 to Week 51) were performed to evaluate long-term effects, including immunogenicity (i.e. ADAs), and the effects of repeated switching between GP2017 and Humira.

Official Title
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A Randomized, Double-blind, Multicenter Study to Demonstrate Equivalent Efficacy and to Compare Safety and Immunogenicity of a Biosimilar Adalimumab (GP2017) and Humira® in Patients With Moderate to Severe Chronic Plaque-type Psoriasis

Conditions
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Plaque Type Psoriasis

Intervention / Treatment
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* Drug: GP2017 Adalimumab
* Drug: Humira ® Adalimumab


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Men or women at least 18 years of age at time of screening Chronic plaque-type psoriasis diagnosed for at least 6 months before randomization Moderate to severe psoriasis as defined at baseline by: PASI score of 12 or greater Investigator´s Global Assessment score of 3 or greater (based on a scale of 0 - 4) and, Body Surface Area affected by plaque-type psoriasis of 10% or greater Chronic plaque-type psoriasis patients who have previously received phototherapy or systemic psoriasis therapy at least once or who are candidates for such therapies in the opinion of the investigator. Exclusion Criteria: Forms of psoriasis other than chronic plaque-type Drug-induced psoriasis Ongoing use of prohibited psoriasis treatments Previous exposure to adalimumab Active ongoing inflammatory diseases other than psoriasis that might confound the evaluation of the benefit of treatment with adalimumab Other In-/Exclusion criteria may apply

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 |
| --- | --- |
| Experimental: GP2017 Adalimumab<br>Study arm with intervention being studied in the protocol. Adalimumab Solution for subcutaneous injection with an initial dose of 80 mg s.c. in Week 0, followed by 40 mg s.c. eow, starting at Week 1 and ending at Week 51. | Drug: GP2017 Adalimumab<br> <br> |
| Active Comparator: Humira ® Adalimumab<br>Humira® Adalimumab as a subcutaneous injection with an initial dose of 80 mg s.c. in Week 0, followed by 40 mg s.c. eow, starting at Week 1 and ending at Week 51. | Drug: Humira ® Adalimumab<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PASI 75 Response Rate at Week 16 - GP2017 Adalimumab vs Humira ® Adalimumab | The primary variable was the PASI75 response rate at Week 16, defined as the proportion of patients achieving a reduction of 75% or more of the PASI score at Week 16 compared with baseline. | At Week 16 only | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Percent Change From Baseline in PASI Score up to Week 16 (MMRM) | The key secondary efficacy variable was the percentage change from baseline in PASI score at each visit up to Week 16. | Baseline to Week 16 | 
| Mean ATE of Percent Change From Baseline in PASI Score up to Week 16 (ANCOVA) | The key secondary efficacy variable was the average treatment effect (ATE) which is the weighted average of % change from baseline in PASI scores between Week 1 and Week 16 (weights based on the time interval between two consecutive visits). | Baseline to Week 16 | 
| PASI 50, PASI 75, PASI 90 and PASI 100 Response Rates | Proportion of patients achieving PASI 50, 75, 90 and 100 at Week 17 (end of Treatment Period 1) | At Week 17 only | 
| PASI 50, PASI75, PASI 90 and PASI100 Response Rates | Proportion of Patients Achieving PASI 50, 75, 90 and 100 at Week 35 (end of Treatment Period 2) | At Week 35 only | 
| PASI 50, PASI75, PASI 90 and PASI100 Response Rates | Proportion of Patients Achieving PASI 50, 75, 90 and 100 at Week 51 (Entire Study) | At Week 51 only | 
| IGA Response Rate | Proportion of patients achieving a score of 0 (clear) or 1 (almost clear) or improved by at least 2 points of the IGA scale compared to baseline at Week 17. | At Week 17 only | 
| IGA Response Rate | Proportion of patients achieving a score of 0 (clear) or 1 (almost clear) or improved by at least 2 points of the IGA scale compared to baseline at Week 51 | At Week 35 only | 
| IGA Response Rate | Proportion of patients achieving a score of 0 (clear) or 1 (almost clear) or improved by at least 2 points of the IGA scale compared to baseline at Week 51 | At Week 51 only | 
| DLQI | Proportion of patients reporting a DLQI of 0 or 1 (no effect at all on patient's life) | At Week 17 only | 
| DLQI | Proportion of patients reporting a DLQI of 0 or 1 (no effect at all on patient's life) | At Week 35 only | 
| DLQI | Proportion of patients reporting a DLQI of 0 or 1 (no effect at all on patient's life) | At Week 51 only | 
| ADA Formation Against GP2017 Adalimumab and Humira® Adalimumab From Randomization Until Week 17 | Proportion of patients with at least one confirmed positive anti-drug antibodies (ADA) response to adalimumab from Randomization to Week 17. Patients with ADA positive results at baseline were excluded from subsequent results. | At Week 17 only | 
| ADA Formation Against GP2017 Adalimumab and Humira® Adalimumab From Randomization Until Week 51 | Proportion of patients with at least one confirmed positive anti-drug antibodies (ADA) response to adalimumab from Randomization to Week 51. Patients with ADA positive results at baseline were excluded from subsequent results. | At Week 51 only | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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plaque type psoriasis, equivalent efficacy, safety and immunogenicity, GP2017, Humira®