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RecruitingNCT07265284Updated Dec 22, 2025

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

A Phase 3 interventional study of IBI112 and placebo in Psoriasis, sponsored by Innovent Biopharmaceutical Technology (Hangzhou) Co., LTD.. Recruiting at 1 site in China. Open to participants aged 12 Years to 18 Years. Per ClinicalTrials.gov, last updated 2025-12-22.

Sponsored by Innovent Biopharmaceutical Technology (Hangzhou) Co., LTD. · Phase 3, Interventional, and Treatment

From the registry’s dates

  • Started Dec 2025; still recruiting 10 months later.
Phase
Phase 3
Study type
Interventional
Enrollment
104
Allocation
Randomized
Ages
12 Years to 18 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Psoriasis

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03

In context

Psoriasis

1,899 studies on the registry are indexed under Psoriasis; 233 are open to participants now.

This study's planned enrollment of 104 is above the median of 70 across 1,447 interventional studies indexed under Psoriasis.

Browse Psoriasis studies →

Lead sponsor

Innovent Biopharmaceutical Technology (Hangzhou) Co., LTD. is the lead sponsor of 7 studies on the registry; 6 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
12 Years to 18 Years
Sexes eligible
All
Accepts 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

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

05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
104 participants (estimated)

Study arms

  • Placebo comparator
    placebo

    Participants receive placebo through week 16,placebo participants will cross over to receive IBI112 through week 44

    Drug: placebo

  • Experimental
    IBI112

    Participants receive IBI112 through week 44

    Drug: IBI112

Interventions

  • DrugIBI112

    IBI112 by subcutaneous injection

  • Drugplacebo

    placebo by subcutaneous injection

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: week 16

  2. 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.

    Time frame: week 16

Secondary outcomes

  1. Percentage of patients achieving PASI 50 at week 16

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

    Time frame: week 16

  2. Percentage of patients achieving PASI 90 at week 16

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

    Time frame: week 16

  3. Percentage of patients achieving PASI 100 at week 16

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

    Time frame: week 16

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

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

    Time frame: week 16

  5. 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

    Time frame: week 16

  6. Percentage of patients achieving PASI 75 at week 56

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

    Time frame: week 56

  7. Percentage of patients achieving PASI 90 at week 56

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

    Time frame: week 56

  8. Percentage of patients achieving PASI 100 at week 56

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

    Time frame: week 56

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

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

    Time frame: week 56

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

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

    Time frame: week 56

07

Study locations

1 of 1 sites recruiting
  • Beijing Children's Hospital Affiliated to Capital Medical University
    Beijing, Beijing Municipality 100000, China
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 22, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT07265284
Lead sponsor
Innovent Biopharmaceutical Technology (Hangzhou) Co., LTD.
Responsible party
Sponsor
First posted
Dec 4, 2025
Start date
Dec 3, 2025
Primary completion
Sep 30, 2026 (estimated)
Completion
Jan 31, 2029 (estimated)
Last update
Dec 22, 2025

Study contacts

Bingjing Feng
Contact
bingjing.feng@innoventbio.com
+86 18361923769

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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