Psoriasis
Conditions
Brief summary
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.
Interventions
DRUGIBI112
IBI112 by subcutaneous injection
DRUGplacebo
placebo by subcutaneous injection
Sponsors
Innovent Biopharmaceutical Technology (Hangzhou) Co., LTD.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
12 Years to 18 Years
Healthy volunteers
No
Inclusion criteria
Males or females aged 12 to 18 years; Diagnosed with plaque psoriasis and a history of psoriasis ≥6 months; suitable for phototherapy and/or systemic treatment for psoriasis.
Exclusion criteria
History of or current signs or symptoms of severe, progressive, or uncontrolled renal, hepatic, hematological, gastrointestinal, endocrine, pulmonary, cardiac, neurologic, cerebral, or psychiatric disease Participant has history of erythrodermic psoriasis, generalized or localized pustular psoriasis, medication-induced or medication-exacerbated psoriasis, or new onset guttate psoriasis Has received any therapeutic agent directly targeted to IL-17within 6 months of the first administration of study agent Has received any therapeutic agent directly targeted toTNF-a within 3 months of the first administration of study agent Has received any conventional therapeutic agent within 1 months of the first administration of study agent Has received any topic therapeutic agent within 2 weeks of the first administration of study agent Hsa received IBI112
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of patients achieving Psoriasis Area and severity index(PASI) 75 at week 16 | week 16 | PASI 75 is defined as at least a 75% reduction in PASI relative to baseline |
| Percentage of patients achieving an static Physician's Global Assessment (sPGA) Score of Cleared (0) or Minimal (1) at Week 16 | week 16 | sPGA of psoriasis is used to determine the participant's psoriasis lesions overall. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of patients achieving PASI 100 at week 56 | week 56 | PASI 100 is defined as at least a 100% reduction in PASI relative to baseline |
| Percentage of patients achieving an sPGA 0/1 at Week 56 | week 56 | sPGA of psoriasis is used to determine the participant's psoriasis lesions overall. |
| Percentage of patients achieving PASI 50 at week 16 | week 16 | PASI 50 is defined as at least a 50% reduction in PASI relative to baseline |
| Percentage of patients achieving PASI 90 at week 16 | week 16 | PASI 90 is defined as at least a 90% reduction in PASI relative to baseline |
| Percentage of patients achieving PASI 75 at week 56 | week 56 | PASI 75 is defined as at least a 75% reduction in PASI relative to baseline |
| Percentage of patients achieving an sPGA 0 at week 16 | week 16 | sPGA of psoriasis is used to determine the participant's psoriasis lesions overall. |
| Percentage of patients achieving an Children Dermatology life quality index (CDLQI) Score of 0 /1at week 16 | week 16 | The CDLQI is a 10-item questionnaire that measures the impact of skin disease on participant's quality of life |
| Percentage of patients achieving an sPGA 0 at Week 56 | week 56 | sPGA of psoriasis is used to determine the participant's psoriasis lesions overall. |
| Percentage of patients achieving PASI 100 at week 16 | week 16 | PASI 100 is defined as at least a 100% reduction in PASI relative to baseline |
| Percentage of patients achieving PASI 90 at week 56 | week 56 | PASI 90 is defined as at least a 90% reduction in PASI relative to baseline |
Countries
China
Contacts
Primary ContactBingjing Feng
Outcome results
None listed