IBI112 in Moderate to Severe Plaque Psoriasis With Randomized Withdrawal and Re-treatment
NCT ID: NCT06049810
Last Updated: 2025-08-17
Study Results
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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COMPLETED
PHASE3
566 participants
INTERVENTIONAL
2023-10-10
2025-07-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Group 3
Participants receive Dose 1 IBI112 through week 8 \& Dose 2 IBI112 on week 20 \& Dose 1 IBI112 through week 44
IBI112
Participants receive Dose 1 IBI112 through week 8 \& Dose 2 IBI112 on week 20 \& Dose 1 IBI112 through week 44
Group 4
Participants receive Dose 1 IBI112 through week 8 \& Dose 3 IBI112 through week 44
IBI112
Participants receive Dose 1 IBI112 through week 8 \& Dose 3 IBI112 through week 44
Group 6
Participants receive Dose 1 IBI112 through week 8 \& Dose 3 IBI112 on week 20 \& Dose 1 IBI112 through week 44
IBI112
Participants receive Dose 1 IBI112 through week 8 \& Dose 3 IBI112 on week 20 \& Dose 1 IBI112 through week 44
Group 5
Participants receive Dose 1 IBI112 through week 8 \& Dose 3 IBI112 on week 20 \& placebo through week 44
IBI112/placebo
Participants receive Dose 1 IBI112 through week 8 \& Dose 3 IBI112 on week 20 \& placebo through week 44
Group 1
Participants receive Dose 1 IBI112 through week 8 \& Dose 2 IBI112 through week 44
IBI112
Participants receive Dose 1 IBI112 through week 8 \& Dose 2 IBI112 through week 44 by subcutaneous injection
Group 2
Participants receive Dose 1 IBI112 through week 8 \& Dose 2 IBI112 on week 20 \& placebo through week 44
IBI112/placebo
Participants receive Dose 1 IBI112 through week 8 \& Dose 2 IBI112 on week 20 \& placebo through week 44 by subcutaneous injection
Interventions
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IBI112
Participants receive Dose 1 IBI112 through week 8 \& Dose 2 IBI112 on week 20 \& Dose 1 IBI112 through week 44
IBI112/placebo
Participants receive Dose 1 IBI112 through week 8 \& Dose 2 IBI112 on week 20 \& placebo through week 44 by subcutaneous injection
IBI112/placebo
Participants receive Dose 1 IBI112 through week 8 \& Dose 3 IBI112 on week 20 \& placebo through week 44
IBI112
Participants receive Dose 1 IBI112 through week 8 \& Dose 3 IBI112 on week 20 \& Dose 1 IBI112 through week 44
IBI112
Participants receive Dose 1 IBI112 through week 8 \& Dose 3 IBI112 through week 44
IBI112
Participants receive Dose 1 IBI112 through week 8 \& Dose 2 IBI112 through week 44 by subcutaneous injection
Eligibility Criteria
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Inclusion Criteria
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
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
18 Years
75 Years
ALL
No
Sponsors
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Innovent Biologics (Suzhou) Co. Ltd.
INDUSTRY
Responsible Party
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Locations
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Shanghai Skin Disease Hospital
Shanghai, Shanghai Municipality, China
Countries
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Other Identifiers
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CIBI112A302CN
Identifier Type: -
Identifier Source: org_study_id
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