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.

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06049810

Enrollment

566

Registered

2023-09-22

Start date

2023-10-10

Completion date

2025-07-28

Last updated

2025-08-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Psoriasis

Brief 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

Interventions

DRUGIBI112

Participants receive Dose 1 IBI112 through week 8 & Dose 2 IBI112 on week 20 & Dose 1 IBI112 through week 44

DRUGIBI112/placebo

Participants receive Dose 1 IBI112 through week 8 & Dose 2 IBI112 on week 20 & placebo through week 44 by subcutaneous injection

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Caregiver, Investigator)

Masking description

Participant, Care Provider, Investigator

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

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

Design outcomes

Primary

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

Secondary

Measure	Time frame
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 PASI75 Response	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
Percentage of participants with a sIGA score of 0	Week 56

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026