CClinicalTrials.gg
TerminatedNCT07314060Updated Aug 3, 2026

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

A Phase 2 interventional study of TQH2929 Injections and TQH2929 Placebo in Generalized Pustular Psoriasis, sponsored by Chia Tai Tianqing Pharmaceutical Group Co., Ltd.. Terminated at 31 sites in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-08-03.

Sponsored by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. · Phase 2, Interventional, and Treatment

Why this study was terminated
Due to the company's strategic adjustment in product portfolio, this study has been voluntarily terminated.
Phase
Phase 2
Study type
Interventional
Enrollment
36
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Generalized Pustular Psoriasis

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03

In context

Psoriasis

1,899 studies on the registry are indexed under Psoriasis; 233 are open to participants now.

This study's enrollment of 36 is below the median of 70 across 1,447 interventional studies indexed under Psoriasis.

Browse Psoriasis studies →

Lead sponsor

Chia Tai Tianqing Pharmaceutical Group Co., Ltd. is the lead sponsor of 313 studies on the registry; 75 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
36 participants (actual)

Study arms

  • Experimental
    TQH2929 Injections

    Intravenous infusion, single dose

    Drug: TQH2929 Injections

  • Placebo comparator
    TQH2929 Placebo

    Intravenous infusion, single dose

    Drug: TQH2929 Placebo

Interventions

  • DrugTQH2929 Injections

    TQH2929 is a humanized monoclonal antibody that interfering with the signal cascade.

  • DrugTQH2929 Placebo

    Placebo contains no active substance.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 1 week

Secondary outcomes

  1. 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.

    Time frame: 1 week and 4 weeks

  2. 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.

    Time frame: 1 week and 4 weeks

  3. 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.

    Time frame: 1 week and 4 weeks

  4. 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.

    Time frame: 1 week and 4 weeks

  5. 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

    Time frame: 1 week and 4 weeks

  6. 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.

    Time frame: 4 weeks

  7. Change from baseline in Psoriasis Symptom Scale (PSS) score

    Change from baseline in Psoriasis Symptom Scale (PSS) score at week 4

    Time frame: 4 weeks

  8. 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.

    Time frame: 4 weeks

  9. 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.

    Time frame: 113 days or 169 days

  10. 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.

    Time frame: 113 days or 169 days

  11. 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.

    Time frame: 113 days or 169 days

  12. Abnormal clinical laboratory examination indicators

    Any laboratory abnormalities that occur during the test.

    Time frame: 113 days or 169 days

  13. 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.

    Time frame: 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

  14. Maximum Concentration (Cmax)

    The highest blood concentration reached after the drug is absorbed in the body.

    Time frame: 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

  15. 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.

    Time frame: 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

  16. 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.

    Time frame: 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

  17. Apparent Clearance (CL/F)

    The sum of drug clearance rates of liver and kidney, etc.

    Time frame: 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

  18. Plasma half-life time (t1/2)

    The time it takes for the concentration of the drug in the plasma to drop by half.

    Time frame: 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

  19. Anti-drug antibody (ADA)

    Incidence of anti-drug antibodies (ADA) in subjects.

    Time frame: Through study completion, an average of half a year

07

Study locations

31 sites
  • Peking University First Hospita
    Beijing, Beijing Municipality 100034, China
  • Peking University Third Hospital
    Beijing, Beijing Municipality 100191, China
  • The First Affiliated Hospital of Fujian Medical University
    Fuzhou, Fujian 350000, China
  • Southern Medical University Dermatology Hospital
    Guangzhou, Guangdong 510091, China
  • Sun Yat-sen Memorial Hospital, Sun Yat-sen University
    Guangzhou, Guangdong 510120, China
  • The Affiliated Hospital of Guizhou Medical University
    Guiyang, Guizhou 550004, China
  • The Second Hospital Of Hebei Medical University
    Shijiazhuang, Hebei 050000, China
  • The Second Affiliated Hospital of Henan University of science and technology
    Luoyang, Henan 471000, China
  • Zhengzhou Central Hospital
    Zhengzhou, Henan 450000, China
  • Henan Provincial People's Hospital
    Zhengzhou, Henan 450003, China
  • The fifth Affiliated hospital of zhengzhou university
    Zhengzhou, Henan 450052, China
  • Shiyan Renmin Hospital
    Shiyan, Hubei 442000, China
  • Renmin Hospital of Wuhan University
    Wuhan, Hubei 430060, China
  • The First Hospital of Hunan University of Chinese Medicine
    Changsha, Hunan 410007, China
  • Xiangya Hospital of Central South University
    Changsha, Hunan 410008, China
  • The General Hospital Of Hunan University Of Medicine
    Huaihua, Hunan 41800, China
  • The first hospital of jilin university
    Changchun, Jilin 130012, China
  • The first hospital of china medical university
    Shenyang, Liaoning 110001, China
  • Shandong First Medical University Affiliated Dermatology Hospital
    Jinan, Shandong 250022, China
  • Shanghai Skin Disease Hospital
    Shanghai, Shanghai Municipality 200443, China
  • The Second Affiliated Hospital of Xi'an Jiaotong University
    Xi’an, Shanxi 710061, China
  • Chengdu Second People's Hospital
    Chengdu, Sichuan 610000, China
  • Sichuan Provincial People' s Hospital
    Chengdu, Sichuan 610000, China
  • The Affiliated Hospital of Southwest Medical University
    Luzhou, Sichuan 646000, China
  • Tianjin Medical University General Hospital
    Tianjin, Tianjin Municipality 300052, China
  • Tianjin Academy of Traditional Chinese Medicine Affiliated Hospital
    Tianjin, Tianjin Municipality 300120, China
  • People's Hospital of Xinjiang Uygur Autonomous Region
    Ürümqi, Xinjiang 830001, China
  • The First Affiliated Hospital of Xinjiang Medical University
    Ürümqi, Xinjiang 830013, China
  • The First Affiliated Hospital of Kunming Medical University
    Kunming, Yunnan 650032, China
  • Jiaxing First Hospital
    Jiaxing, Zhejiang 314001, China
  • The first affiliated hospital of ningbo university
    Ningbo, Zhejiang 315020, China
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 3, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT07314060
Lead sponsor
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Responsible party
Sponsor
First posted
Jan 2, 2026
Start date
Mar 19, 2026
Primary completion
Jul 30, 2026
Completion
Jul 30, 2026
Last update
Aug 3, 2026

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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