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

NCT ID: NCT07265284

Last Updated: 2025-12-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE3

Total Enrollment

104 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-12-03

Study Completion Date

2029-01-31

Brief Summary

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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.

Detailed Description

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Conditions

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Psoriasis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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placebo

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

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

placebo by subcutaneous injection

IBI112

Participants receive IBI112 through week 44

Group Type EXPERIMENTAL

IBI112

Intervention Type DRUG

IBI112 by subcutaneous injection

Interventions

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IBI112

IBI112 by subcutaneous injection

Intervention Type DRUG

placebo

placebo by subcutaneous injection

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

12 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Innovent Biopharmaceutical Technology (Hangzhou) Co., LTD.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Beijing Children's Hospital Affiliated to Capital Medical University

Beijing, Beijing Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Bingjing Feng

Role: CONTACT

Phone: +86 18361923769

Email: [email protected]

Facility Contacts

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Zigang Xu

Role: primary

Other Identifiers

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CIBI112A304

Identifier Type: -

Identifier Source: org_study_id