The purpose of this research study is to compare the efficacy and safety of SCT630 and adalimumab (HUMIRA®) in adults with plaque psoriasis.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
330
Administered by subcutaneous injection
Administered by subcutaneous injection
First Affiliated Hospital of Fourth Military Medical University
Xi'an, Shaanxi, China
Percent Improvement From Baseline in Psoriasis Area and Severity Index (PASI) at Week 16
The PASI measures the average redness (erythema), thickness (induration), and scaliness (each graded on a 0 to 4 scale) of psoriasis lesions, weighted by the area of involvement in the four main body areas (i.e., head and neck, trunk, upper extremities, and lower extremities). PASI scores can range from 0.0 to 72.0, with higher scores indicating greater severity and/or more extensive psoriasis. Percent improvement from baseline was calculated as (value at baseline - value at post-baseline visit) × 100 / (value at baseline).
Time frame: Baseline and Week 16
Percent Improvement From Baseline in PASI at Week 4、8、12、24、32、48、50
The PASI measures the average redness (erythema), thickness (induration), and scaliness (each graded on a 0 to 4 scale) of psoriasis lesions, weighted by the area of involvement in the four main body areas (i.e., head and neck, trunk, upper extremities, and lower extremities). PASI scores can range from 0.0 to 72.0, with higher scores indicating greater severity and/or more extensive psoriasis. Percent improvement from baseline is calculated as (value at baseline - value at post-baseline visit) × 100 / (value at baseline).
Time frame: Baseline and week 4、8、12、24、32、48、50
Percentage of Participants With a PASI 75 Response at Week 4、8、12、16、24、32、48、50
A PASI 75 response is a 75% or greater improvement (reduction) from baseline in PASI score. The PASI measures the average redness (erythema), thickness (induration), and scaliness (each graded on a 0 to 4 scale) of psoriasis lesions, weighted by the area of involvement in the four main body areas (i.e., head and neck, trunk, upper extremities, and lower extremities). PASI scores can range from 0.0 to 72.0, with higher scores indicating greater severity and/or more extensive psoriasis.
Time frame: Baseline and Week 4、8、12、16、24、32、48、50
Percentage of Participants With a PASI 50 Response at Week 4、8、12、16、24、32、48、50
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A PASI 50 response is a 50% or greater improvement (reduction) from baseline in PASI score. The PASI measures the average redness (erythema), thickness (induration), and scaliness (each graded on a 0 to 4 scale) of psoriasis lesions, weighted by the area of involvement in the four main body areas (i.e., head and neck, trunk, upper extremities, and lower extremities). PASI scores can range from 0.0 to 72.0, with higher scores indicating greater severity and/or more extensive psoriasis.
Time frame: Baseline and Week 4、8、12、16、24、32、48、50
Percentage of Participants With a PASI 90 Response at Week 4、8、12、16、24、32、48、50
A PASI 90 response is a 90% or greater improvement (reduction) from baseline in PASI score. The PASI measures the average redness (erythema), thickness (induration), and scaliness (each graded on a 0 to 4 scale) of psoriasis lesions, weighted by the area of involvement in the four main body areas (i.e., head and neck, trunk, upper extremities, and lower extremities). PASI scores can range from 0.0 to 72.0, with higher scores indicating greater severity and/or more extensive psoriasis.
Time frame: Baseline and Week 4、8、12、16、24、32、48、50
Percentage of Participants With a PASI 100 Response at Week 4、8、12、16、24、32、48、50
A PASI 100 response is a 100% or greater improvement (reduction) from baseline in PASI score. The PASI measures the average redness (erythema), thickness (induration), and scaliness (each graded on a 0 to 4 scale) of psoriasis lesions, weighted by the area of involvement in the four main body areas (i.e., head and neck, trunk, upper extremities, and lower extremities). PASI scores can range from 0.0 to 72.0, with higher scores indicating greater severity and/or more extensive psoriasis.
Time frame: Baseline and Week 4、8、12、16、24、32、48、50
Percentage of Participants With a Static Physician's Global Assessment (sPGA) Response at Week 4、8、12、16、24、32、48、50
The sPGA is a 6-point scale ranging from 0 (clear) to 5 (very severe) used to measure the severity of disease (induration, scaling, and erythema). A sPGA response is defined as a sPGA value of clear (score 0) or almost clear (score 1).
Time frame: Week 4、8、12、16、24、32、48、50
Change From Baseline in the Percentage of Body Surface Area (BSA) Involved With Psoriasis at Week 4、8、12、16、24、32、48、50
A measurement of psoriasis involvement, given as the physician's assessment of the percentage of the participant's total body surface area (BSA) involved with psoriasis. The percent of BSA affected was estimated by assuming that the subject's palm, excluding the fingers and thumb, represented roughly 1% of the body's surface. Change from baseline is calculated as (value at post-baseline visit - value at baseline). A decrease from baseline (negative value) indicates improvement.
Time frame: Baseline and Week 4、8、12、16、24、32、48、50
Change From Baseline of dermatology life quality index (DLQI)at Week 4、8、12、16、24、32、48、50
Time frame: Baseline and Week 4、8、12、16、24、32、48、50
Positive rate of ADA and NAb
Comparision of the positive rate of ADA and NAb between the SCT630 and EU-licensed Humira
Time frame: Week1、4、16、32、48、50、52
Number of Participants With Adverse Events
Time frame: Week2、4、8、12、16、24、32、40、48、52
Minimum Concentration of SCT630 and EU-licensed Humira
Time frame: Week1、4、16、32、48、50