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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| placebo | Placebo Comparator | Participants receive placebo through week 16,placebo participants will cross over to receive IBI112 through week 44 |
|
| IBI112 | Experimental | Participants receive IBI112 through week 44 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IBI112 | Drug | IBI112 by subcutaneous injection |
| |
| placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage 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 | 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. | week 16 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of patients achieving PASI 50 at week 16 | PASI 50 is defined as at least a 50% reduction in PASI relative to baseline | 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 |
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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
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Bingjing Feng | Contact | +86 18361923769 | bingjing.feng@innoventbio.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Children's Hospital Affiliated to Capital Medical University | Recruiting | Beijing | Beijing Municipality | 100000 | 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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| Drug |
placebo by subcutaneous injection |
|
| 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 | 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. | 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 | week 16 |
| Percentage of patients achieving PASI 75 at week 56 | PASI 75 is defined as at least a 75% reduction in PASI relative to baseline | 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 | 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 | 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. | 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. | week 56 |