The purpose of this study is to evaluate the efficacy and safety of IBI112 in the treatment of adolescent participants with moderate to severe plaque-type psoriasis.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
104
Beijing Children's Hospital Affiliated to Capital Medical University
Beijing, Beijing Municipality, China
RECRUITINGPercentage of patients achieving Psoriasis Area and severity index(PASI) 75 at week 16
PASI 75 is defined as at least a 75% reduction in PASI relative to baseline
Time frame: week 16
Percentage of patients achieving an static Physician's Global Assessment (sPGA) Score of Cleared (0) or Minimal (1) at Week 16
sPGA of psoriasis is used to determine the participant's psoriasis lesions overall.
Time frame: week 16
Percentage of patients achieving PASI 50 at week 16
PASI 50 is defined as at least a 50% reduction in PASI relative to baseline
Time frame: week 16
Percentage of patients achieving PASI 90 at week 16
PASI 90 is defined as at least a 90% reduction in PASI relative to baseline
Time frame: week 16
Percentage of patients achieving PASI 100 at week 16
PASI 100 is defined as at least a 100% reduction in PASI relative to baseline
Time frame: week 16
Percentage of patients achieving an sPGA 0 at week 16
sPGA of psoriasis is used to determine the participant's psoriasis lesions overall.
Time frame: week 16
Percentage of patients achieving an Children Dermatology life quality index (CDLQI) Score of 0 /1at week 16
The CDLQI is a 10-item questionnaire that measures the impact of skin disease on participant's quality of life
Time frame: week 16
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Percentage of patients achieving PASI 75 at week 56
PASI 75 is defined as at least a 75% reduction in PASI relative to baseline
Time frame: week 56
Percentage of patients achieving PASI 90 at week 56
PASI 90 is defined as at least a 90% reduction in PASI relative to baseline
Time frame: week 56
Percentage of patients achieving PASI 100 at week 56
PASI 100 is defined as at least a 100% reduction in PASI relative to baseline
Time frame: week 56
Percentage of patients achieving an sPGA 0/1 at Week 56
sPGA of psoriasis is used to determine the participant's psoriasis lesions overall.
Time frame: week 56
Percentage of patients achieving an sPGA 0 at Week 56
sPGA of psoriasis is used to determine the participant's psoriasis lesions overall.
Time frame: week 56