TQH2929 injection for acute generalized pustular psoriasis flares

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

This study tries TQH2929 injections to see if they calm and clear acute flare-ups of generalized pustular psoriasis in adults.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 36 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd. (Industry-sponsored)
• Locations: 32 sites (Beijing, Beijing Municipality and 31 other locations)
• Trial ID: NCT07314060 on ClinicalTrials.gov

What this trial studies

This is a randomized, double-blind, placebo-controlled Phase II trial enrolling 36 adults with acute generalized pustular psoriasis flares across multiple centers in China. Participants receive either TQH2929 injections or matching placebo and are monitored for clinical response and safety. Eligibility is confirmed using the ERASPEN diagnostic criteria for acute GPP and requires adherence to study visits and contraception rules for women of childbearing potential. The trial's outcomes focus on reduction of pustules and systemic symptoms along with the recording of adverse events.

Who should consider this trial

Good fit: Adults aged 18–75 with acute-onset generalized pustular psoriasis meeting ERASPEN criteria who can attend the Beijing or Fuzhou sites and agree to protocol procedures are ideal candidates.

Not a fit: Patients whose pustules are limited to plaque psoriasis, who have other skin conditions that interfere with evaluation, or who have severe uncontrolled medical disease are unlikely to benefit from this intervention.

Why it matters

Potential benefit: If successful, TQH2929 could shorten and reduce the severity of GPP flares, improving symptoms and lowering the need for hospital-level care.

How similar studies have performed: Related biologic approaches, including IL-36 receptor inhibitors like spesolimab, have shown clinical benefit for GPP flares, giving precedent for targeted injectable therapies.

Eligibility criteria

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.

Where this trial is running

Beijing, Beijing Municipality and 31 other locations

• Peking University First Hospita — Beijing, Beijing Municipality, China (Recruiting)
• Peking University Third Hospital — Beijing, Beijing Municipality, China (Not_yet_recruiting)
• The First Affiliated Hospital of Fujian Medical University — Fuzhou, Fujian, China (Not_yet_recruiting)
• Southern Medical University Dermatology Hospital — Guangzhou, Guangdong, China (Not_yet_recruiting)
• Sun Yat-sen Memorial Hospital, Sun Yat-sen University — Guangzhou, Guangdong, China (Not_yet_recruiting)
• The Affiliated Hospital of Guizhou Medical University — Guiyang, Guizhou, China (Not_yet_recruiting)
• The Second Hospital Of Hebei Medical University — Shijiazhuang, Hebei, China (Not_yet_recruiting)
• The Second Affiliated Hospital of Henan University of science and technology — Luoyang, Henan, China (Not_yet_recruiting)
• Zhengzhou Central Hospital — Zhengzhou, Henan, China (Not_yet_recruiting)
• Henan Provincial People's Hospital — Zhengzhou, Henan, China (Not_yet_recruiting)
• The fifth Affiliated hospital of zhengzhou university — Zhengzhou, Henan, China (Not_yet_recruiting)
• Shiyan Renmin Hospital — Shiyan, Hubei, China (Not_yet_recruiting)
• Renmin Hospital of Wuhan University — Wuhan, Hubei, China (Not_yet_recruiting)
• The First Hospital of Hunan University of Chinese Medicine — Changsha, Hunan, China (Not_yet_recruiting)
• Xiangya Hospital of Central South University — Changsha, Hunan, China (Not_yet_recruiting)
• The General Hospital Of Hunan University Of Medicine — Huaihua, Hunan, China (Not_yet_recruiting)
• The first hospital of jilin university — Changchun, Jilin, China (Not_yet_recruiting)
• The first hospital of china medical university — Shenyang, Liaoning, China (Not_yet_recruiting)
• Shandong First Medical University Affiliated Dermatology Hospital — Jinan, Shandong, China (Not_yet_recruiting)
• Shanghai Skin Disease Hospital — Shanghai, Shanghai Municipality, China (Not_yet_recruiting)
• The Second Affiliated Hospital of Xi'an Jiaotong University — Xi’an, Shanxi, China (Not_yet_recruiting)
• Chengdu Second People's Hospital — Chengdu, Sichuan, China (Not_yet_recruiting)
• Sichuan Provincial People' s Hospital — Chengdu, Sichuan, China (Not_yet_recruiting)
• The Affiliated Hospital of Southwest Medical University — Luzhou, Sichuan, China (Not_yet_recruiting)
• The Affiliated Hospital of Southwest Medical University — Luzhou, Sichuan, China (Not_yet_recruiting)
• Tianjin Medical University General Hospital — Tianjin, Tianjin Municipality, China (Not_yet_recruiting)
• Tianjin Academy of Traditional Chinese Medicine Affiliated Hospital — Tianjin, Tianjin Municipality, China (Not_yet_recruiting)
• People's Hospital of Xinjiang Uygur Autonomous Region — Ürümqi, Xinjiang, China (Not_yet_recruiting)
• The First Affiliated Hospital of Xinjiang Medical University — Ürümqi, Xinjiang, China (Not_yet_recruiting)
• The First Affiliated Hospital of Kunming Medical University — Kunming, Yunnan, China (Not_yet_recruiting)
• Jiaxing First Hospital — Jiaxing, Zhejiang, China (Not_yet_recruiting)
• The first affiliated hospital of ningbo university — Ningbo, Zhejiang, China (Not_yet_recruiting)

Study contacts

• Study coordinator: Hang Li, Doctor

Conditions Generalized Pustular Psoriasis