Actively Recruiting
A Phase 3 Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Picankibart in Adolescent Patients With Moderate to Severe Plaque Psoriasis
Led by Innovent Biopharmaceutical Technology (Hangzhou) Co., LTD. · Updated on 2025-12-22
104
Participants Needed
1
Research Sites
122 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the efficacy and safety of IBI112 in treating adolescents aged 12 to 18 years with moderate to severe plaque-type psoriasis. This phase 3, multicenter, randomized, double-blind, placebo-controlled study aims to better understand how well IBI112 works and its safety profile in this patient group. Participants are randomly assigned to receive either placebo or IBI112 by subcutaneous injection through week 16. After week 16, those initially on placebo will switch to receive IBI112 through week 44. The study includes a treatment period lasting up to 44 weeks, with ongoing monitoring during this time. Throughout the study, participants will be assessed for improvements in psoriasis using measures such as the Psoriasis Area and Severity Index (PASI) and the static Physician's Global Assessment (sPGA) at weeks 16 and 56. Quality of life is also evaluated using the Children Dermatology Life Quality Index (CDLQI). Researchers will monitor safety, treatment response, and overall health during the study period, which lasts until week 56 with follow-up assessments.
CONDITIONS
Brief Title
A Study to Evaluate Efficacy and Safety of IBI112 in Adolescent Participants With Moderate to Severe Plaque Psoriasis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Males or females aged 12 to 18 years
- Diagnosed with plaque psoriasis with a history of psoriasis for at least 6 months
- Suitable for phototherapy and/or systemic treatment for psoriasis
You will not qualify if you...
- History or current signs of severe, progressive, or uncontrolled renal, hepatic, hematological, gastrointestinal, endocrine, pulmonary, cardiac, neurologic, cerebral, or psychiatric disease
- History of erythrodermic psoriasis, generalized or localized pustular psoriasis, medication-induced or medication-exacerbated psoriasis, or new onset guttate psoriasis
- Received any therapeutic agent targeting IL-17 within 6 months before study start
- Received any therapeutic agent targeting TNF-alpha within 3 months before study start
- Received any conventional therapeutic agent within 1 month before study start
- Received any topical therapeutic agent within 2 weeks before study start
- Previously received IBI112
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 44 weeks
Participants receive IBI112 or placebo by subcutaneous injection to treat moderate to severe plaque psoriasis.
Regular visits through week 44
Trial Site Locations
Total: 1 location
1
Beijing Children's Hospital Affiliated to Capital Medical University
Beijing, Beijing Municipality, China, 100000
Actively Recruiting
Research Team
B
Bingjing Feng
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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