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

This study is a real-world clinical research on adalimumab. The project plans to enroll 30 subjects. The safety and efficacy of adalimumab injection for adult non-infectious uveitis are being investigated. The time of treatment failure for subjects at 6 weeks of treatment or between 6 and 24 weeks of treatment is the primary endpoint.

Study Overview

• Status: Not yet recruiting
• Conditions: Adult Non-infectious Uveitis
• Intervention / Treatment: Drug: TyboWe® Adalimumab Injection

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Manli Li, Doctor; Phone Number: 15093292527; Email: 343507699@qq.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• The subject must sign an informed consent form for data collection and data validation, and the research protocol/informed consent form must comply with local legal and regulatory requirements;
• Age 18 or above, gender unrestricted;
• Diagnosed with active non-infectious intermediate, posterior, or panuveitis, defined as the presence of at least one of the following conditions in at least one eye: active, inflammatory chorioretinopathy and/or inflammatory retinal vasculitis; ≥2+ AC cells (according to the Standardization of Uveitis Nomenclature [SUN] criteria); or ≥2+ VH (National Eye Institute/SUN criteria);
• The subject had received oral prednisone (or equivalent corticosteroid medication) at a dose of ≥10 mg to 60 mg/day for ≥2 weeks prior to screening and remained on the same dose at baseline, with corresponding documentation provided;
• The subject (including their partner) agrees to have no pregnancy or sperm donation plans during the entire trial period and for six months after the study concludes, and voluntarily adopts effective contraceptive measures;
• Adult subjects with non-infectious uveitis who were prescribed TEBOV® adalimumab injection by physicians after a thorough risk/benefit assessment.

Exclusion Criteria:

• (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;
• Within 30 days prior to the baseline, an increase in the dose of other concomitant immunosuppressive therapy or failure to meet any of the following conditions: methotrexate (MTX) ≤25 mg/week; cyclosporine ≤4 mg/kg/day; mycophenolate (or equivalent dose of mycophenolic acid) ≤2 g/day; azathioprine ≤175 mg/day; tacrolimus oral ≤8 mg/day;Subjects who have received any live vaccine within 3 months prior to the first dose of Tadabow® Adalimumab injection, or who plan to receive live vaccines during the study;(7) Subjects currently participating in other clinical studies;
• Subjects deemed unsuitable for participation in this trial by the investigator.
• Within 90 days prior to baseline, intravitreal injection of anti Vascular Endothelial Growth Factor (VEGF) therapy (such as ranibizumab, aflibercept, or conbercept) has been administered;
• Within 90 days prior to baseline, methotrexate was injected into the vitreous body for treatment;
• Ozurdex implantation (dexamethasone implantation) was performed within 6 months prior to baseline;
• Have received treatment with anti-tumor necrosis factor TNF or other potential therapeutic agents for uveitis within the past 6 months (excluding intravitreal injection of anti VEGF drugs);
• After receiving the first dose of Taibowei ® Individuals who have received any live vaccine within the past 3 months prior to Adalimumab injection, or those who plan to receive a live vaccine during the study period;
• Participants who are currently participating in other clinical studies;
• Researchers believe that participants who are not suitable to participate in this trial.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: TyboWe® Adalimumab Injection 40mg; The initial subcutaneous dose is 80mg, followed by 40mg subcutaneous injections every 2 weeks starting 1 week after the first administration.	Drug: TyboWe® Adalimumab Injection; Adalimumab is a fully human anti-tumour necrosis factor-alpha monoclonal antibody that inhibits the downstream inflammatory cascade by blocking Tumor Necrosis Factor (TNF) α, a core inflammatory factor in psoriasis.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time of treatment failure in subjects	Time to treatment failure at week 6 or between weeks 6 and 24.	Week 6, week 24

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of subjects meeting treatment failure criteria	Proportion of subjects meeting the treatment failure criteria at week 6 and week 24	Week 6, week 24
The proportion of subjects with inactive inflammatory choroidoretinitis and/or inflammatory retinal vasculopathy in both eyes	The proportion of subjects with inactive inflammatory choroidoretinitis and/or inflammatory retinal vasculopathy in both eyes at week 24 compared to the proportion of subjects with inactive inflammatory choroidoretinitis and/or inflammatory retinal vasculopathy in both eyes at baseline.	Week 24

Collaborators and Investigators

• Sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): February 1, 2028
• Study Completion (Estimated): February 1, 2028

Study Registration Dates

• First Submitted: June 18, 2026
• First Submitted That Met QC Criteria: June 18, 2026
• First Posted (Actual): June 23, 2026

Study Record Updates

• Last Update Posted (Actual): June 23, 2026
• Last Update Submitted That Met QC Criteria: June 18, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: ADM-IV-04

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No