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New treatment option for Generalized Pustular Psoriasis
Official title A Clinical Trial of TQH2929 Injection in Patients With Acute Flare-up of Generalized Pustular Psoriasis
ClinicalTrials.gov ID: NCT07314060
What this study is testing
What is TQH2929 Injections?
TQH2929 Injections is an investigational medicine, given as an injectable medicine, being studied as a potential treatment for generalized pustular psoriasis.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- 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...
- 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;
You likely can't join if
- 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...
- 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 people in the past 6 months...
- History of serious infection leading to hospitalization within 2 months prior to baseline;
See the full eligibility 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 people of childbearing age should agree that contraceptive measures must be used during the study and for 6 months after the end of the study;
- 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 people 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;
- people with any type of active malignancy or a history of malignancy;
- Alcohol, drug and known drug dependence;
- Pregnant or lactating women;
- people cannot tolerate intravenous infusion administration.
The study team makes the final eligibility decision.
Where it's taking place
- Beijing, Beijing Municipality, China
- Fuzhou, Fujian, China
- Guangzhou, Guangdong, China
- Guiyang, Guizhou, China
- Shijiazhuang, Hebei, China
- Luoyang, Henan, China
- Zhengzhou, Henan, China
- Shiyan, Hubei, China
- Wuhan, Hubei, China
- Changsha, Hunan, China
- Huaihua, Hunan, China
- Changchun, Jilin, China
- Shenyang, Liaoning, China
- Jinan, Shandong, China
- Shanghai, Shanghai Municipality, China
- Xi’an, Shanxi, China
- Chengdu, Sichuan, China
- Luzhou, Sichuan, China
- Tianjin, Tianjin Municipality, China
- Ürümqi, Xinjiang, China
+ 3 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Beijing, Beijing Municipality, China; Fuzhou, Fujian, China; Guangzhou, Guangdong, China; Guiyang, Guizhou, China; Shijiazhuang, Hebei, China; Luoyang, Henan, China and 17 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.