A Clinical Trial of TQH2929 Injection in Patients With Acute Flare-up of Generalized Pustular Psoriasis
NCT ID: NCT07314060
Last Updated: 2026-01-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
PHASE2
36 participants
INTERVENTIONAL
2026-03-31
2027-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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TQH2929 Injections
Intravenous infusion, single dose
TQH2929 Injections
TQH2929 is a humanized monoclonal antibody that interfering with the signal cascade.
TQH2929 Placebo
Intravenous infusion, single dose
TQH2929 Placebo
Placebo contains no active substance.
Interventions
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TQH2929 Injections
TQH2929 is a humanized monoclonal antibody that interfering with the signal cascade.
TQH2929 Placebo
Placebo contains no active substance.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
75 Years
ALL
No
Sponsors
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Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
INDUSTRY
Responsible Party
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Locations
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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
The Second Affiliated Hospital of Xi'an Jiaotong University
Xi’an, Shanxi, China
Chengdu Second People's Hospital
Chengdu, Sichuan, China
Sichuan Provincial People' s Hospital
Chengdu, Sichuan, China
The Affiliated Hospital of Southwest Medical University
Luzhou, Sichuan, China
The Affiliated Hospital of Southwest Medical University
Luzhou, Sichuan, China
Tianjin Medical University General Hospital
Tianjin, Tianjin Municipality, China
Tianjin Academy of Traditional Chinese Medicine Affiliated Hospital
Tianjin, Tianjin Municipality, China
People's Hospital of Xinjiang Uygur Autonomous Region
Ürümqi, Xinjiang, China
The First Affiliated Hospital of Xinjiang Medical University
Ürümqi, Xinjiang, China
The First Affiliated Hospital of Kunming Medical University
Kunming, Yunnan, China
Jiaxing First Hospital
Jiaxing, Zhejiang, China
The first affiliated hospital of ningbo university
Ningbo, Zhejiang, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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TQH2929-II-01
Identifier Type: -
Identifier Source: org_study_id
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