Actively Recruiting
Phase 12 Study of IBI112 Injection to Treat Moderate to Severe Plaque Psoriasis in Adolescents Ages 12 to 18
Led by Innovent Biopharmaceutical Technology (Hangzhou) Co., LTD. · Updated on 2025-12-22
104
Participants Needed
1
Research Sites
122 weeks
Total Duration
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 Physicians 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
Research Team
B
Bingjing Feng
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