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IBI112 in Moderate to Severe Plaque Psoriasis With Randomized Withdrawal and Re-treatment | Clinical Trials | Clareo Health

COMPLETEDPHASE3

IBI112 in Moderate to Severe Plaque Psoriasis With Randomized Withdrawal and Re-treatment

A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Randomized Withdrawal and Retreatment Phase III Clinical Trial Evaluating the Efficacy and Safety of Subcutaneous Injection of IBI112 in the Treatment of Moderate to Severe Plaque Psoriasis.

NCT06049810•Innovent Biologics (Suzhou) Co. Ltd.

View on ClinicalTrials.gov

Summary

The purpose of this study is to evaluate the efficacy, safety, and tolerability of IBI112 in the treatment of participants with moderate to severe psoriasis

Eligibility

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Have a diagnosis of plaque-type psoriasis for at least 6 months;
•2. Psoriasis Area and Severity Index (PASI) score of 12 or greater, AND static Physician's Global Assessment (sPGA) score of 3 (moderate) or greater; Psoriasis covering at least 10% of body surface area;
•3. Must be a candidate for either systemic therapy or phototherapy for psoriasis.

Exclusion Criteria

•1. Has any condition that, in the opinion of the investigator, would make participation not be in the best interest (for example, compromise the well-being) of the participant or that could prevent, limit, or confound the protocol-specified assessments
•2. Participants who have ever received IBI112 or IL-23 inhibitor
•3. History or current signs or symptoms of severe, progressive, or uncontrolled renal, hepatic, cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, rheumatologic, psychiatric, or metabolic disturbances
•4. Has any condition that, in the opinion of the investigator, would make participation not be in the best interest of the participant
•5. Is pregnant, nursing, or planning a pregnancy (both men and women) within 6 months following the last administration of the study drug

Locations (1)

Shanghai Skin Disease Hospital

Shanghai, Shanghai Municipality, China

Key Dates

Start Date

October 10, 2023

Primary Completion Date

April 29, 2025

Completion Date

July 28, 2025

Last Updated

August 17, 2025

Enrollment

566

ACTUAL participants

Conditions

Psoriasis

Interventions

IBI112

DRUG

IBI112/placebo

DRUG

IBI112/placebo

DRUG

IBI112

DRUG

IBI112

DRUG

IBI112

DRUG

A Study of Guselkumab After Switching From Ustekinumab in Participants With Moderate to Severe Psoriasis

NCT07449234

Psoriasis

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RECRUITINGPHASE3

Long-Term Safety Study of Deucravacitinib Versus Ustekinumab in Participants With Psoriasis (PRAGMATYK)

NCT07116967

Plaque Psoriasis

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RECRUITINGPHASE3

A Long-Term Study of Zasocitinib in Children and Teenagers With Plaque Psoriasis

NCT07250802

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: August 17, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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IBI112 in Moderate to Severe Plaque Psoriasis With Randomized Withdrawal and Re-treatment

Inclusion Criteria

Exclusion Criteria

A Study of Guselkumab After Switching From Ustekinumab in Participants With Moderate to Severe Psoriasis

Long-Term Safety Study of Deucravacitinib Versus Ustekinumab in Participants With Psoriasis (PRAGMATYK)

A Long-Term Study of Zasocitinib in Children and Teenagers With Plaque Psoriasis

An Open-Label Extension Study of ORKA-001 in Participants With Plaque Psoriasis

Dose Ranging Study of ORKA-001 in Patients With Moderate-to-Severe Plaque Psoriasis

Real-Life Evaluation of Guselkumab Dosing Interval Adjustments