Clinical trial NCT06049810: IBI112 in Moderate to Severe Plaque Psoriasis With Randomized Withdrawal and Re-treatment
Official title: 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.
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE3
Conditions: Psoriasis
Lead sponsor: Innovent Biologics (Suzhou) Co. Ltd.
Sponsor class: INDUSTRY
First posted: 2023-09-22
Enrollment: 550
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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

Primary outcomes:
measure: Percentage of participants with a Psoriasis Area and Severity Index (PASI) 90 Response
timeFrame: Week 56
Secondary outcomes:
measure: Percentage of participants with a PASI75 Response
timeFrame: Week 56
measure: Percentage of participants with a PASI100 Response
timeFrame: Week 56
measure: Percentage of participants with a static Investigator's Global Assessment (sIGA) score of 0 or 1
timeFrame: Week 56
measure: Percentage of participants with Dermatology Life Quality Index (DLQI) Score
timeFrame: Week 56
measure: Percentage of participants with a sIGA score of 0
timeFrame: Week 56
measure: Cumulative Maintenance Rate of PASI 90 Response Through Week 56 to Evaluate Loss of a PASI 90 Response
timeFrame: Week 56
measure: Changes of PASI Scores participants who relapse and retreatment
timeFrame: Week 56
measure: Changes of sIGA score in participants who relapse and retreatment
timeFrame: Week 56
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Skin Disease Hospital
state: Shanghai
Study officials:
References: