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

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.

Study Overview

• Status: Terminated
• Conditions: Generalized Pustular Psoriasis
• Intervention / Treatment: Drug: TQH2929 Injections; Drug: TQH2929 Placebo

• Study Type: Interventional
• Enrollment (Actual): 36
• Phase: Phase 2

Contacts and Locations

Study Locations

• China
  • Beijing Municipality
    • Beijing, Beijing Municipality, China, 100191
      • Peking University Third Hospital
    • Beijing, Beijing Municipality, China, 100034
      • Peking University First Hospita
  • Fujian
    • Fuzhou, Fujian, China, 350000
      • The First Affiliated Hospital of Fujian Medical University
  • Guangdong
    • Guangzhou, Guangdong, China, 510120
      • Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University
    • Guangzhou, Guangdong, China, 510091
      • Southern Medical University Dermatology Hospital
  • Guizhou
    • Guiyang, Guizhou, China, 550004
      • The Affiliated Hospital of Guizhou Medical University
  • Hebei
    • Shijiazhuang, Hebei, China, 050000
      • The Second Hospital of Hebei Medical University
  • Henan
    • Luoyang, Henan, China, 471000
      • The Second Affiliated Hospital of Henan University of Science and Technology
    • Zhengzhou, Henan, China, 450003
      • Henan Provincial People's Hospital
    • Zhengzhou, Henan, China, 450000
      • Zhengzhou Central Hospital
    • Zhengzhou, Henan, China, 450052
      • The fifth Affiliated hospital of zhengzhou university
  • Hubei
    • Shiyan, Hubei, China, 442000
      • Shiyan Renmin Hospital
    • Wuhan, Hubei, China, 430060
      • Renmin Hospital of Wuhan University
  • Hunan
    • Changsha, Hunan, China, 410008
      • Xiangya Hospital of Central South University
    • Changsha, Hunan, China, 410007
      • The First Hospital of Hunan University of Chinese Medicine
    • Huaihua, Hunan, China, 41800
      • The General Hospital of Hunan University of Medicine
  • Jilin
    • Changchun, Jilin, China, 130012
      • The First Hospital of Jilin University
  • Liaoning
    • Shenyang, Liaoning, China, 110001
      • The First Hospital of China Medical University
  • Shandong
    • Jinan, Shandong, China, 250022
      • Shandong First Medical University Affiliated Dermatology Hospital
  • Shanghai Municipality
    • Shanghai, Shanghai Municipality, China, 200443
      • Shanghai Skin Disease Hospital
  • Shanxi
    • Xi’an, Shanxi, China, 710061
      • The Second Affiliated Hospital of Xi'an Jiaotong University
  • Sichuan
    • Chengdu, Sichuan, China, 610000
      • Chengdu Second People's Hospital
    • Chengdu, Sichuan, China, 610000
      • Sichuan Provincial People' s Hospital
    • Luzhou, Sichuan, China, 646000
      • The Affiliated Hospital of Southwest Medical University
  • Tianjin Municipality
    • Tianjin, Tianjin Municipality, China, 300052
      • Tianjin Medical University General Hospital
    • Tianjin, Tianjin Municipality, China, 300120
      • Tianjin Academy of Traditional Chinese Medicine Affiliated Hospital
  • Xinjiang
    • Ürümqi, Xinjiang, China, 830001
      • People's Hospital of Xinjiang Uygur Autonomous Region
    • Ürümqi, Xinjiang, China, 830013
      • The First Affiliated Hospital of Xinjiang Medical University
  • Yunnan
    • Kunming, Yunnan, China, 650032
      • The First Affiliated Hospital of Kunming Medical University
  • Zhejiang
    • Jiaxing, Zhejiang, China, 314001
      • Jiaxing First Hospital
    • Ningbo, Zhejiang, China, 315020
      • The First Affiliated Hospital of Ningbo University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: TQH2929 Injections; Intravenous infusion, single dose	Drug: TQH2929 Injections; TQH2929 is a humanized monoclonal antibody that interfering with the signal cascade.
Placebo Comparator: TQH2929 Placebo; Intravenous infusion, single dose	Drug: TQH2929 Placebo; Placebo contains no active substance.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of patients with a score of 0 for the pustule subterm	Percentage of patients with a Physician's Global Assessment of Generalized Pustular Psoriasis (GPPGA) pustular subitem of 0 (no visible pustules) at week 1 among all enrolled patients.	1 week

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of patients with a Generalized Pustular Psoriasis Physician Global Assessment(GPPGA) total score of 0 or 1	Percentage of patients with a total Generalized Pustular Psoriasis Physician Global Assessment (GPPGA) score of 0 (clear) or 1 (almost clear) at weeks 1 and 4.	1 week and 4 weeks
Percentage change from baseline in Generalized Pustular Psoriasis Area and Severity Index (GPPASI) total score	Percentage change from baseline in the total score of generalized pustular psoriasis area and severity index (GPPASI) at week 1 and week 4.	1 week and 4 weeks
Change from baseline in Generalized Pustular Psoriasis Area and Severity Index(GPPASI) total score	Change from baseline in Generalized Pustular Psoriasis Area and Severity Index(GPPAS) total score at week 1 and week 4. If lower than the baseline score, indicate a certain degree of disease relief; conversely, if higher, it indicates an aggravation of the disease symptoms.	1 week and 4 weeks
Percentage of patients with Generalized Pustular Psoriasis Area and Severity Index(GPPASI) 50	Percentage of patients who achieved Generalized Pustular Psoriasis Area and Severity Index(GPPASI) 50 at week 1 and week 4.	1 week and 4 weeks
Percentage of patients with Generalized Pustular Psoriasis Area and Severity Index(GPPASI) 75	Percentage of patients who achieved Generalized Pustular Psoriasis Area and Severity Index(GPPASI) 75 at week 1 and week 4	1 week and 4 weeks
Percentage of patients with pustule subterm achieving a score of 0	Percentage of patients with Generalized Pustular Psoriasis Physician Global Assessment(GPPGA) pustule subterm achieving a score of 0 (no visible pustules) at week 4.	4 weeks
Change from baseline in Psoriasis Symptom Scale (PSS) score	Change from baseline in Psoriasis Symptom Scale (PSS) score at week 4	4 weeks
Change from baseline in disease life quality index (DLQI)	Change from baseline in skin disease life quality index (DLQI) at week 4. If lower than the baseline score, indicate a certain degree of disease relief; conversely, if higher, it indicates an aggravation of the disease symptoms.	4 weeks
Adverse Drug Event (AE)	Any untoward medical occurrence of a subject following drug treatment or exposure to an experimental factor, whether or not causally related to treatment or exposure.	113 days or 169 days
Serious Adverse Event (SAE)	An event that occurs in the course of a clinical trial that results in the death of a subject or patient, serious deterioration in health, hospitalization or prolongation of hospitalization, permanent disability or loss of function, or serious consequences such as birth defects or birth defects.	113 days or 169 days
Treatment-Emergent Adverse Events (TEAES)	Adverse events that occur during treatment, including from the start of treatment to a certain period of time after the end of treatment, may be directly or indirectly related to treatment.	113 days or 169 days
Abnormal clinical laboratory examination indicators	Any laboratory abnormalities that occur during the test.	113 days or 169 days
Time of maximum concentration (Tmax)	It refers to the time it takes for the human blood concentration curve to reach the highest concentration (peak concentration) after a single dose, measured in hours or minutes.	1 hour pre-dose on day 1, immediately post dose, 1, 6, 24, 48, 168, 336, 504, 672, 1344, 2016, 2688 hours post dose. Day 8 Immediately after the end of salvage therapy administration, 1, 6, 24, 48 hours post dose
Maximum Concentration (Cmax)	The highest blood concentration reached after the drug is absorbed in the body.	1 hour pre-dose on day 1, immediately post dose, 1, 6, 24, 48, 168, 336, 504, 672, 1344, 2016, 2688 hours post dose. Day 8 Immediately after the end of salvage therapy administration, 1, 6, 24, 48 hours post dose
Area Under the Curve (AUC)	It refers to the area covered by the concentration of a drug in the blood under the curve of changes over time.	1 hour pre-dose on day 1, immediately post dose, 1, 6, 24, 48, 168, 336, 504, 672, 1344, 2016, 2688 hours post dose. Day 8 Immediately after the end of salvage therapy administration, 1, 6, 24, 48 hours post dose
Apparent Volume of Distribution(Vd/F)	When the drug reaches dynamic equilibrium in the body, the ratio of the amount of drug in the body to the blood concentration is called the apparent volume of distribution.	1 hour pre-dose on day 1, immediately post dose, 1, 6, 24, 48, 168, 336, 504, 672, 1344, 2016, 2688 hours post dose. Day 8 Immediately after the end of salvage therapy administration, 1, 6, 24, 48 hours post dose
Apparent Clearance (CL/F)	The sum of drug clearance rates of liver and kidney, etc.	1 hour pre-dose on day 1, immediately post dose, 1, 6, 24, 48, 168, 336, 504, 672, 1344, 2016, 2688 hours post dose. Day 8 Immediately after the end of salvage therapy administration, 1, 6, 24, 48 hours post dose
Plasma half-life time (t1/2)	The time it takes for the concentration of the drug in the plasma to drop by half.	1 hour pre-dose on day 1, immediately post dose, 1, 6, 24, 48, 168, 336, 504, 672, 1344, 2016, 2688 hours post dose. Day 8 Immediately after the end of salvage therapy administration, 1, 6, 24, 48 hours post dose
Anti-drug antibody (ADA)	Incidence of anti-drug antibodies (ADA) in subjects.	Through study completion, an average of half a year

Collaborators and Investigators

• Sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): March 19, 2026
• Primary Completion (Actual): July 30, 2026
• Study Completion (Actual): July 30, 2026

Study Registration Dates

• First Submitted: December 15, 2025
• First Submitted That Met QC Criteria: December 31, 2025
• First Posted (Actual): January 2, 2026

Study Record Updates

• Last Update Posted (Actual): August 3, 2026
• Last Update Submitted That Met QC Criteria: July 31, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases; Psoriasis
• Other Study ID Numbers: TQH2929-II-01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No