Moderate to severe plaque psoriasis
Conditions
Interventions
Experimental group:Treatment with Trastuzumab deruxtecan
Sponsors
Guangzhou Dermatology Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1.When signing the informed consent form, individuals must be 18 years of age or older, regardless of gender. 2.Diagnosed with moderate to severe plaque psoriasis (meeting the diagnostic criteria of the "Chinese Guidelines for the Diagnosis and Treatment of Psoriasis (2023 Edition)"), and the investigator has determined that treatment with tildrakizumab is appropriate. 3.Agree to have no plans for pregnancy during the trial period and within six months after the last dose, and voluntarily take effective contraceptive measures. 4.The patient voluntarily signs the informed consent and agrees to regular follow-up visits.
Exclusion criteria
Exclusion criteria: 1.Patients who used other biologic agents or immunomodulators within the four half-lives prior to the start of this study and during the study; 2.There is evidence indicating that the patient has severe, progressive, or uncontrollable cardiovascular diseases, neuromuscular disorders, hematological diseases, respiratory diseases, digestive system disorders, urinary system diseases, endocrine or metabolic disorders, neurological or psychiatric disorders, severe infectious diseases, and the like. 3.Have received or plan to undergo any major surgery within 12 weeks before first using the investigational drug; 4.Suffering from active, recurrent, or chronic infections (such as active tuberculosis or hepatitis); 5.Having a malignant tumor or a history of malignant tumors (except for those who have undergone radical tumor surgery or treatment and have been free of recurrence or metastasis for more than 5 years); 6.Women who are pregnant, breastfeeding, or unable to use effective contraception; 7.Researchers believe there may be other circumstances that could pose a threat to patient safety or affect the study results.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| At 28 weeks of treatment, the absolute changes and percentages of the frequencies and absolute numbers of CD4?CD69?TRM cells and CD8?CD103?TRM cells in the skin lesion area's skin cell suspension compared to the baseline were measured. Change; | — |
Secondary
| Measure | Time frame |
|---|---|
| At 28 weeks of treatment, the intracellular factor staining of TRM cells in the lesion area detected the production of IL-17A, IFN-?, and TNF-a compared to the baseline level.;Treatment of changes in the transcriptional expression of TRM cell-related genes (such as CD69, CD103, CXCR6) in the lesion area compared to the baseline after 28 weeks of treatment;The changes in peripheral blood inflammatory factors IL-17A, IFN-?, and TNF-a at 28 weeks compared to the baseline, and their correlation with the therapeutic effect of tirapizumab;The proportion of patients achieving PASI 75/90/100 at 28 weeks of treatment, as well as the changes in PASI score compared to the baseline.;After 28 weeks of treatment, the correlation between the changes in TRM cells and clinical efficacy indicators (such as PASI score) was analyzed.; | — |
Countries
China
Contacts
Public ContactLuo Quan
Guangzhou Dermatology Hospital
Outcome results
None listed