A Study to Evaluate Efficacy and Safety of IBI112 in Adolescent Participants With Moderate to Severe Plaque Psoriasis
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: IBI112, placebo.
- Who it may be relevant to
- Registry conditions: Psoriasis. Basic parameters: 12 years — 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
A Phase Ⅰ/Ⅲ Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Picankibart in Adolescent Patients With Moderate to Severe Plaque Psoriasis
Overview
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
- Drug IBI112
IBI112 by subcutaneous injection - Drug placebo
placebo by subcutaneous injection
Primary outcome measures
- Percentage of patients achieving Psoriasis Area and severity index(PASI) 75 at week 16 [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 [Time frame: week 16]
Secondary outcome measures (10)
- Percentage of patients achieving PASI 50 at week 16 [Time frame: week 16]
- Percentage of patients achieving PASI 90 at week 16 [Time frame: week 16]
- Percentage of patients achieving PASI 100 at week 16 [Time frame: week 16]
- Percentage of patients achieving an sPGA 0 at week 16 [Time frame: week 16]
- Percentage of patients achieving an Children Dermatology life quality index (CDLQI) Score of 0 /1at week 16 [Time frame: week 16]
- Percentage of patients achieving PASI 75 at week 56 [Time frame: week 56]
- Percentage of patients achieving PASI 90 at week 56 [Time frame: week 56]
- Percentage of patients achieving PASI 100 at week 56 [Time frame: week 56]
- Percentage of patients achieving an sPGA 0/1 at Week 56 [Time frame: week 56]
- Percentage of patients achieving an sPGA 0 at Week 56 [Time frame: week 56]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Treatment
Study locations
China · 1 center
- Beijing Children's Hospital Affiliated to Capital Medical University — Beijing
Identifiers
NCT: NCT07265284 · CIBI112A304