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RECRUITINGPhase 2INTERVENTIONAL

A Clinical Trial of TQH2929 Injection in Patients With Acute Flare-up of Generalized Pustular Psoriasis

A Multicenter, Randomized, Double-blind, Placebo-controlled Phase II Clinical Trial Evaluating the Efficacy and Safety of TQH2929 Injection in Patients With Acute Exacerbations of Generalized Pustular Psoriasis

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

Who May Be Eligible (Plain English)

Who May Qualify: - 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 willing to sign a consent form form; - Willing and compliant with study visits and related procedures; - Female subjects of childbearing age should agree that contraceptive measures must be used during the study and for 6 months after the end of the study; Who Should NOT Join This Trial: - 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; - Presence of severe, progressive, or uncontrolled disease, or signs and symptoms that are not suitable for participation in the investigator, in the judgment of the investigator: - 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; - History of serious infection leading to hospitalization within 2 months prior to baseline; - Active infection requiring systemic antibiotics, systemic antifungals, or systemic antiviral therapy within 2 weeks prior to baseline, according to the investigator's assessment; - History of opportunistic infection within 6 months prior to baseline; - Received live (attenuated) vaccine treatment within 12 weeks prior to baseline; - Any major surgery within 4 weeks prior to baseline or planned major surgery during the study; - Received blood transfusion within 4 weeks prior to baseline; ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
Inclusion Criteria: * 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; * Willing and compliant with study visits and related procedures; * Female subjects of childbearing age should agree that contraceptive measures must be used during the study and for 6 months after the end of the study; Exclusion Criteria: * 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; * Presence of severe, progressive, or uncontrolled disease, or signs and symptoms that are not suitable for participation in the investigator, in the judgment of the investigator: * 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; * History of serious infection leading to hospitalization within 2 months prior to baseline; * Active infection requiring systemic antibiotics, systemic antifungals, or systemic antiviral therapy within 2 weeks prior to baseline, according to the investigator's assessment; * History of opportunistic infection within 6 months prior to baseline; * Received live (attenuated) vaccine treatment within 12 weeks prior to baseline; * Any major surgery within 4 weeks prior to baseline or planned major surgery during the study; * Received blood transfusion within 4 weeks prior to baseline; * Participated in clinical trials of other drugs or medical devices within 4 weeks before baseline; * Any known or suspected congenital or acquired immunodeficiency state or condition that may compromise the subject's immune status; * Subjects with any type of active malignancy or a history of malignancy; * Alcohol, drug and known drug dependence; * Pregnant or lactating women; * Subjects cannot tolerate intravenous infusion administration.

Treatments Being Tested

DRUG

TQH2929 Injections

TQH2929 is a humanized monoclonal antibody that interfering with the signal cascade.

DRUG

TQH2929 Placebo

Placebo contains no active substance.

Locations (20)

Peking University First Hospita
Beijing, Beijing Municipality, China
Peking University Third Hospital
Beijing, Beijing Municipality, China
The First Affiliated Hospital of Fujian Medical University
Fuzhou, Fujian, China
Southern Medical University Dermatology Hospital
Guangzhou, Guangdong, China
Sun Yat-sen Memorial Hospital, Sun Yat-sen University
Guangzhou, Guangdong, China
The Affiliated Hospital of Guizhou Medical University
Guiyang, Guizhou, China
The Second Hospital Of Hebei Medical University
Shijiazhuang, Hebei, China
The Second Affiliated Hospital of Henan University of science and technology
Luoyang, Henan, China
Zhengzhou Central Hospital
Zhengzhou, Henan, China
Henan Provincial People's Hospital
Zhengzhou, Henan, China
The fifth Affiliated hospital of zhengzhou university
Zhengzhou, Henan, China
Shiyan Renmin Hospital
Shiyan, Hubei, China
Renmin Hospital of Wuhan University
Wuhan, Hubei, China
The First Hospital of Hunan University of Chinese Medicine
Changsha, Hunan, China
Xiangya Hospital of Central South University
Changsha, Hunan, China
The General Hospital Of Hunan University Of Medicine
Huaihua, Hunan, China
The first hospital of jilin university
Changchun, Jilin, China
The first hospital of china medical university
Shenyang, Liaoning, China
Shandong First Medical University Affiliated Dermatology Hospital
Jinan, Shandong, China
Shanghai Skin Disease Hospital
Shanghai, Shanghai Municipality, China