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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
465
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.
Time frame: At Week 16 only
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.
Time frame: 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).
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: At Week 51 only
IGA Response Rate
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Total Skin & Beauty Dermatology Center
Birmingham, Alabama, United States
Alliance Dermatology & MOHS Center, PC
Phoenix, Arizona, United States
Burke Pharmaceutical Research
Hot Springs, Arkansas, United States
Anaheim Clinical Trials
Anaheim, California, United States
Bakersfield Dermatology and Skin Cancer Medical Group
Bakersfield, California, United States
Wallace Medical Group
Beverly Hills, California, United States
California Dermatology & Clinical Research Institute
Encinitas, California, United States
Dr. Howard Sofen
Los Angeles, California, United States
Southern California Permanente Medical Group
Los Angeles, California, United States
Palmtree Clinical Research
Rancho Mirage, California, United States
...and 69 more locations
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.
Time frame: 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
Time frame: 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
Time frame: At Week 51 only
DLQI
Proportion of patients reporting a DLQI of 0 or 1 (no effect at all on patient's life)
Time frame: At Week 17 only
DLQI
Proportion of patients reporting a DLQI of 0 or 1 (no effect at all on patient's life)
Time frame: At Week 35 only
DLQI
Proportion of patients reporting a DLQI of 0 or 1 (no effect at all on patient's life)
Time frame: 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.
Time frame: 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.
Time frame: At Week 51 only