RecruitingPhase 3NCT07265284

A Study to Evaluate Efficacy and Safety of IBI112 in Adolescent Participants With Moderate to Severe Plaque Psoriasis

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


Sponsor

Innovent Biopharmaceutical Technology (Hangzhou) Co., LTD.

Enrollment

104 participants

Start Date

Dec 3, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 12 YearsMax Age: 18 Years

Inclusion Criteria1

  • 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 Criteria1

  • 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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Interventions

DRUGIBI112

IBI112 by subcutaneous injection

DRUGplacebo

placebo by subcutaneous injection


Locations(1)

Beijing Children's Hospital Affiliated to Capital Medical University

Beijing, Beijing Municipality, China

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NCT07265284


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