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The purpose of this research study is to compare the efficacy and safety of SCT630 and adalimumab (HUMIRA®) in adults with plaque psoriasis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SCT630 | Experimental | Participants received 80 mg SCT630 subcutaneously on week 1/day 1 (initial loading dose) and 40 mg at week 2 and every 2 weeks thereafter until week 16. Participants with a PASI 50 response at week 16 continued to receive 40 mg SCT630 until week 48. |
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| adalimumab-EU source | Active Comparator | Participants received 80 mg adalimumab subcutaneously on week 1/day 1 (initial loading dose) and 40 mg at week 2 and every 2 weeks thereafter until week 16. At week 16 participants with a PASI 50 response were re-randomized to treatment with adalimumab or were transitioned to SCT630 until week 48 |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SCT630 | Biological | Administered by subcutaneous injection |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | Baseline and Week 16 |
| Measure | Description | Time Frame |
|---|---|---|
| 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). |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| First Affiliated Hospital of Fourth Military Medical University | Xi'an | Shaanxi | China |
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| ID | Term |
|---|---|
| D011565 | Psoriasis |
| ID | Term |
|---|---|
| D017444 | Skin Diseases, Papulosquamous |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| D000068879 | Adalimumab |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
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| Adalimumab |
| Biological |
Administered by subcutaneous injection |
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| 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. | 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 | 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. | 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. | 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. | 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). | 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. | 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 | 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 | Week1、4、16、32、48、50、52 |
| Number of Participants With Adverse Events | Week2、4、8、12、16、24、32、40、48、52 |
| Minimum Concentration of SCT630 and EU-licensed Humira | Week1、4、16、32、48、50 |
| D007162 |
| Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |