A Multicenter, Open-label Study on the Efficacy and Safety of Tebiovio® (Adalimumab) in Treating Chinese Children With Severe Plaque Psoriasis

Who cannot join

• (Based on the instructions for Tymphul® Adalimumab Injection and the judgment of the treating physician, the subject is not suitable for treatment with Tymphul® Adalimumab Injection.);
• The subject had any of the following ocular events during screening: isolated anterior uveitis; confirmed or suspected infectious uveitis; ocular masquerade syndrome, such as ocular lymphoma; ocular histoplasmosis syndrome; serpiginous choroidopathy; scleritis; corneal or lens opacity impairing fundus visualization or requiring cataract surgery during the trial; macular edema as the sole sign of uveitis; severe VH impairing fundus visualization at baseline; intraocular pressure ≥25 mmHg with use of ≥2 glaucoma medications or evidence of glaucomatous optic neuropathy; best-corrected visual acuity (BCVA) of less than 20 letters (ETDRS) in either eye at baseline; proliferative or severe nonproliferative diabetic retinopathy or clinically significant macular edema caused by diabetic retinopathy; neovascular (wet) age-related macular degeneration; vitreoretinal interface abnormalities (e.g., vitreomacular traction, epiretinal membrane, etc.) that may lead to macular structural damage unrelated to inflammatory processes; ocular surgery performed within 90 days prior to the baseline visit, excluding refractive laser surgery, retinal laser photocoagulation, or Yttrium Aluminum Garnet (YAG) (neodymium-doped yttrium-aluminum-garnet) posterior capsulotomy;
• The subject has any of the following medical conditions or diseases: current or past history of demyelinating diseases (including multiple sclerosis and optic neuritis) or neurological symptoms indicative of demyelinating diseases, including but not limited to optic neuritis; current or past history of systemic lupus erythematosus; arrhythmia (QTc ≥450ms for males, QTc ≥470ms for females); moderate to severe congestive heart failure (New York Heart Association Class III-IV); recent cerebrovascular accident and any other medical history deemed by the investigator to pose a risk to the subject's participation in the study; any malignant tumor (except successfully treated non-melanoma skin cancer or localized cervical carcinoma in situ); any other clinically significant medical condition that the investigator deems to interfere with the subject's participation in the study or render the subject ineligible for the investigational drug, or any other reason;
• Individuals allergic to the active ingredients (and their excipients) and/or similar products;
• During the screening period or baseline visit, individuals with systemic inflammatory diseases requiring continued oral corticosteroid therapy or immunosuppressive treatment;
• Infections requiring intravenous antimicrobial treatment within 30 days prior to the baseline visit, or infections requiring oral antimicrobial treatment within 14 days prior to the baseline visit;