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.

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

Study Overview

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

• Study Type: Interventional
• Enrollment (Actual): 566
• Phase: Phase 3

Contacts and Locations

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200443
      • Shanghai Skin Disease Hospital

Participation Criteria

Eligibility Criteria

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

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group 3; Participants receive Dose 1 IBI112 through week 8 & Dose 2 IBI112 on week 20 & Dose 1 IBI112 through week 44	Drug: IBI112; Participants receive Dose 1 IBI112 through week 8 & Dose 2 IBI112 on week 20 & Dose 1 IBI112 through week 44; Drug: IBI112; Participants receive Dose 1 IBI112 through week 8 & Dose 3 IBI112 on week 20 & Dose 1 IBI112 through week 44; Drug: IBI112; Participants receive Dose 1 IBI112 through week 8 & Dose 3 IBI112 through week 44; Drug: IBI112; Participants receive Dose 1 IBI112 through week 8 & Dose 2 IBI112 through week 44 by subcutaneous injection
Experimental: Group 4; Participants receive Dose 1 IBI112 through week 8 & Dose 3 IBI112 through week 44	Drug: IBI112; Participants receive Dose 1 IBI112 through week 8 & Dose 2 IBI112 on week 20 & Dose 1 IBI112 through week 44; Drug: IBI112; Participants receive Dose 1 IBI112 through week 8 & Dose 3 IBI112 on week 20 & Dose 1 IBI112 through week 44; Drug: IBI112; Participants receive Dose 1 IBI112 through week 8 & Dose 3 IBI112 through week 44; Drug: IBI112; Participants receive Dose 1 IBI112 through week 8 & Dose 2 IBI112 through week 44 by subcutaneous injection
Experimental: Group 6; Participants receive Dose 1 IBI112 through week 8 & Dose 3 IBI112 on week 20 & Dose 1 IBI112 through week 44	Drug: IBI112; Participants receive Dose 1 IBI112 through week 8 & Dose 2 IBI112 on week 20 & Dose 1 IBI112 through week 44; Drug: IBI112; Participants receive Dose 1 IBI112 through week 8 & Dose 3 IBI112 on week 20 & Dose 1 IBI112 through week 44; Drug: IBI112; Participants receive Dose 1 IBI112 through week 8 & Dose 3 IBI112 through week 44; Drug: IBI112; Participants receive Dose 1 IBI112 through week 8 & Dose 2 IBI112 through week 44 by subcutaneous injection
Placebo Comparator: Group 5; Participants receive Dose 1 IBI112 through week 8 & Dose 3 IBI112 on week 20 & placebo through week 44	Drug: IBI112/placebo; Participants receive Dose 1 IBI112 through week 8 & Dose 2 IBI112 on week 20 & placebo through week 44 by subcutaneous injection; Drug: IBI112/placebo; Participants receive Dose 1 IBI112 through week 8 & Dose 3 IBI112 on week 20 & placebo through week 44
Experimental: Group 1; Participants receive Dose 1 IBI112 through week 8 & Dose 2 IBI112 through week 44	Drug: IBI112; Participants receive Dose 1 IBI112 through week 8 & Dose 2 IBI112 on week 20 & Dose 1 IBI112 through week 44; Drug: IBI112; Participants receive Dose 1 IBI112 through week 8 & Dose 3 IBI112 on week 20 & Dose 1 IBI112 through week 44; Drug: IBI112; Participants receive Dose 1 IBI112 through week 8 & Dose 3 IBI112 through week 44; Drug: IBI112; Participants receive Dose 1 IBI112 through week 8 & Dose 2 IBI112 through week 44 by subcutaneous injection
Placebo Comparator: Group 2; Participants receive Dose 1 IBI112 through week 8 & Dose 2 IBI112 on week 20 & placebo through week 44	Drug: IBI112/placebo; Participants receive Dose 1 IBI112 through week 8 & Dose 2 IBI112 on week 20 & placebo through week 44 by subcutaneous injection; Drug: IBI112/placebo; Participants receive Dose 1 IBI112 through week 8 & Dose 3 IBI112 on week 20 & placebo through week 44

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Percentage of participants with a Psoriasis Area and Severity Index (PASI) 90 Response	Week 56

Secondary Outcome Measures

Outcome Measure	Time Frame
Percentage of participants with a PASI75 Response	Week 56
Percentage of participants with a PASI100 Response	Week 56
Percentage of participants with a static Investigator's Global Assessment (sIGA) score of 0 or 1	Week 56
Percentage of participants with Dermatology Life Quality Index (DLQI) Score	Week 56
Percentage of participants with a sIGA score of 0	Week 56
Cumulative Maintenance Rate of PASI 90 Response Through Week 56 to Evaluate Loss of a PASI 90 Response	Week 56
Changes of PASI Scores participants who relapse and retreatment	Week 56
Changes of sIGA score in participants who relapse and retreatment	Week 56

Collaborators and Investigators

• Sponsor: Innovent Biologics (Suzhou) Co. Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): October 10, 2023
• Primary Completion (Actual): April 29, 2025
• Study Completion (Actual): July 28, 2025

Study Registration Dates

• First Submitted: September 13, 2023
• First Submitted That Met QC Criteria: September 19, 2023
• First Posted (Actual): September 22, 2023

Study Record Updates

• Last Update Posted (Actual): August 17, 2025
• Last Update Submitted That Met QC Criteria: August 13, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases, Papulosquamous; Skin Diseases; Psoriasis
• Other Study ID Numbers: CIBI112A302CN

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No