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

NCT07265284 | Recruiting Phase 3

• 1 other identifier: CIBI112A304
• Study Type: interventional
• Target: 104
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Psoriasis

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (10)

• Percentage of patients achieving PASI 50 at week 16

  week 16

• Percentage of patients achieving PASI 90 at week 16

  week 16

• Percentage of patients achieving PASI 100 at week 16

  week 16

• Percentage of patients achieving an sPGA 0 at week 16

  week 16

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

  week 16

Study Arms (2)

placebo

PLACEBO COMPARATOR

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

Drug: placebo

IBI112

EXPERIMENTAL

Participants receive IBI112 through week 44

Drug: IBI112

Interventions

IBI112 DRUG

IBI112 by subcutaneous injection

IBI112

placebo DRUG

placebo by subcutaneous injection

placebo

Eligibility Criteria

• Age: 12 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (1)

Beijing Children's Hospital Affiliated to Capital Medical University

Beijing, Beijing Municipality, 100000, China

RECRUITING

MeSH Terms

Conditions

Psoriasis

Condition Hierarchy (Ancestors)

Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Central Study Contacts

Bingjing Feng

CONTACT

+86 18361923769; bingjing.feng@innoventbio.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 24, 2025
• First Posted: December 4, 2025
• Study Start: December 3, 2025
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): January 31, 2029
• Last Updated: December 22, 2025

Record last verified: 2025-12

Locations

CN (1)