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NCT Number: NCT07265284

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

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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Key information

Conditions

Psoriasis Skin Diseases Skin Diseases, Papulosquamous Skin and Connective Tissue Diseases

Age range

12 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Beijing Children's Hospital Affiliated to Capital Medical University

Beijing, Beijing Municipality, 100000, China

Location status: Recruiting

Location contact

Zigang Xu

CONTACT

[email protected]

+86 1337011021

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

IBI112

Drug

IBI112 by subcutaneous injection

Placebo

Drug

placebo by subcutaneous injection

Primary outcomes

  1. Percentage of patients achieving Psoriasis Area and severity index(PASI) 75 at week 16

    Time frame: week 16

    PASI 75 is defined as at least a 75% reduction in PASI relative to baseline

  2. 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

    sPGA of psoriasis is used to determine the participant's psoriasis lesions overall.

Secondary outcomes

  1. Percentage of patients achieving PASI 50 at week 16

    Time frame: week 16

    PASI 50 is defined as at least a 50% reduction in PASI relative to baseline

  2. Percentage of patients achieving PASI 90 at week 16

    Time frame: week 16

    PASI 90 is defined as at least a 90% reduction in PASI relative to baseline

  3. Percentage of patients achieving PASI 100 at week 16

    Time frame: week 16

    PASI 100 is defined as at least a 100% reduction in PASI relative to baseline

  4. Percentage of patients achieving an sPGA 0 at week 16

    Time frame: week 16

    sPGA of psoriasis is used to determine the participant's psoriasis lesions overall.

  5. Percentage of patients achieving an Children Dermatology life quality index (CDLQI) Score of 0 /1at week 16

    Time frame: week 16

    The CDLQI is a 10-item questionnaire that measures the impact of skin disease on participant's quality of life

  6. Percentage of patients achieving PASI 75 at week 56

    Time frame: week 56

    PASI 75 is defined as at least a 75% reduction in PASI relative to baseline

  7. Percentage of patients achieving PASI 90 at week 56

    Time frame: week 56

    PASI 90 is defined as at least a 90% reduction in PASI relative to baseline

  8. Percentage of patients achieving PASI 100 at week 56

    Time frame: week 56

    PASI 100 is defined as at least a 100% reduction in PASI relative to baseline

  9. Percentage of patients achieving an sPGA 0/1 at Week 56

    Time frame: week 56

    sPGA of psoriasis is used to determine the participant's psoriasis lesions overall.

  10. Percentage of patients achieving an sPGA 0 at Week 56

    Time frame: week 56

    sPGA of psoriasis is used to determine the participant's psoriasis lesions overall.

Study contacts

Contact information is provided by the study sponsor or research team.

Bingjing Feng

CONTACT

[email protected]

+86 18361923769

Sponsors and collaborators

Lead sponsor

Innovent Biopharmaceutical Technology (Hangzhou) Co., LTD.

Industry

Registry information

Official study 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

Important dates

Study start
2025
Primary completion
2026
Study completion
2029
First posted
Dec 4, 2025
Registry last updated
Dec 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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