This is a multicenter, randomized, double-blind, placebo-controlled phase II clinical study, all subjects need to use TQH2929 injection/placebo. The aim was to demonstrate the efficacy and safety of TQH2929 injection in patients with acute exacerbations of generalized pustular psoriasis, with a total of 36 subjects.
Age ≥ 18 or ≤75 years old at screening, regardless of gender;
Meet the diagnostic criteria defined by the 2017 European Society for Clinical Nutrition and Metabolism (ESPEN) Research Workshop (ERASPEN) consensus and be diagnosed as （generalized pustular psoriasis(GPP);
Compliant with GPP acute onset;
Able to read and understand, and willing to sign the informed consent form;
Pustules are limited to psoriasis vulgaris on psoriasis plaques;
Concomitant skin disease or medical disease that may interfere with the investigator's evaluation of the subject's treatment response;
Serum virological abnormalities during the screening period;
Chest radiology examination shows that the subject has active tuberculosis or a history of contact with open tuberculosis subjects in the past 6 months or a positive Interferon-Gamma Release Assays(IGRA) test;
Parallel
TQH2929 Injections
DrugTQH2929 is a humanized monoclonal antibody that interfering with the signal cascade.
TQH2929 Placebo
DrugPlacebo contains no active substance.
Percentage of patients with a score of 0 for the pustule subterm
Percentage of patients with a Physician's Global Assessment of Generalized Pustular Psoriasis (GPPGA) pustular subitem of 0 (no visible pustules) at week 1 among all enrolled patients.
Percentage of patients with a Generalized Pustular Psoriasis Physician Global Assessment(GPPGA) total score of 0 or 1
Percentage of patients with a total Generalized Pustular Psoriasis Physician Global Assessment (GPPGA) score of 0 (clear) or 1 (almost clear) at weeks 1 and 4.
Percentage change from baseline in Generalized Pustular Psoriasis Area and Severity Index (GPPASI) total score
Percentage change from baseline in the total score of generalized pustular psoriasis area and severity index (GPPASI) at week 1 and week 4.
Change from baseline in Generalized Pustular Psoriasis Area and Severity Index(GPPASI) total score
Change from baseline in Generalized Pustular Psoriasis Area and Severity Index(GPPAS) total score at week 1 and week 4. If lower than the baseline score, indicate a certain degree of disease relief; conversely, if higher, it indicates an aggravation of the disease symptoms.
Percentage of patients with Generalized Pustular Psoriasis Area and Severity Index(GPPASI) 50
Percentage of patients who achieved Generalized Pustular Psoriasis Area and Severity Index(GPPASI) 50 at week 1 and week 4.
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