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
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
36 participants
Mar 19, 2026
INTERVENTIONAL
Conditions
Summary
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.
Eligibility
Inclusion Criteria6
- 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 Criteria17
- 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.
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Interventions
TQH2929 is a humanized monoclonal antibody that interfering with the signal cascade.
Placebo contains no active substance.
Locations(32)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT07314060