Status:
COMPLETED
IBI112 in Moderate to Severe Plaque Psoriasis With Randomized Withdrawal and Re-treatment
Lead Sponsor:
Innovent Biologics (Suzhou) Co. Ltd.
Conditions:
Psoriasis
Eligibility:
All Genders
18-75 years
Phase:
PHASE3
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
Eligibility Criteria
Inclusion
- Have a diagnosis of plaque-type psoriasis for at least 6 months;
- 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;
- Must be a candidate for either systemic therapy or phototherapy for psoriasis.
Exclusion
- 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
- Participants who have ever received IBI112 or IL-23 inhibitor
- 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
- Has any condition that, in the opinion of the investigator, would make participation not be in the best interest of the participant
- Is pregnant, nursing, or planning a pregnancy (both men and women) within 6 months following the last administration of the study drug
Key Trial Info
Start Date :
October 10 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 28 2025
Estimated Enrollment :
566 Patients enrolled
Trial Details
Trial ID
NCT06049810
Start Date
October 10 2023
End Date
July 28 2025
Last Update
August 17 2025
Active Locations (1)
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1
Shanghai Skin Disease Hospital
Shanghai, Shanghai Municipality, China, 200443