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

CTTQ

Status and phase: Begins enrollment this month; Phase 2

Conditions: Generalized Pustular Psoriasis

Treatments: Drug: TQH2929 Injections; Drug: TQH2929 Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT07314060

TQH2929-II-01

Details and patient eligibility

About

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.

Enrollment: 36 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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36 participants in 2 patient groups, including a placebo group

TQH2929 Injections

Experimental group

Description:

Intravenous infusion, single dose

Treatment:

Drug: TQH2929 Injections

TQH2929 Placebo

Placebo Comparator group

Description:

Intravenous infusion, single dose

Treatment:

Drug: TQH2929 Placebo