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

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.

Study Overview

• Status: Recruiting
• Conditions: Psoriasis
• Intervention / Treatment: Drug: placebo; Drug: IBI112

• Study Type: Interventional
• Enrollment (Estimated): 104
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Bingjing Feng; Phone Number: +86 18361923769; Email: bingjing.feng@innoventbio.com

Study Locations

• China
  • Beijing Municipality
    • Beijing, Beijing Municipality, China, 100000
      • Recruiting
      • Beijing Children's Hospital Affiliated to Capital Medical University
      • Contact: Zigang Xu; Phone Number: +86 1337011021; Email: zigangxupek@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: placebo; Participants receive placebo through week 16,placebo participants will cross over to receive IBI112 through week 44	Drug: placebo; placebo by subcutaneous injection
Experimental: IBI112; Participants receive IBI112 through week 44	Drug: IBI112; IBI112 by subcutaneous injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Innovent Biopharmaceutical Technology (Hangzhou) Co., LTD.

Study record dates

Study Major Dates

• Study Start (Actual): December 3, 2025
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): January 31, 2029

Study Registration Dates

• First Submitted: November 24, 2025
• First Submitted That Met QC Criteria: November 24, 2025
• First Posted (Estimated): December 4, 2025

Study Record Updates

• Last Update Posted (Actual): December 22, 2025
• Last Update Submitted That Met QC Criteria: December 19, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases; Psoriasis
• Other Study ID Numbers: CIBI112A304

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No