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Generalized Pustular PsoriasisPhase 2NCT07314060

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

A Phase 2 study testing TQH2929 Injections in people with Generalized Pustular Psoriasis, run by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. at 31 sites in China.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Generalized Pustular Psoriasis
What is being tested?
TQH2929 Injections
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
36 participants
Where
31 sitesChina
Study dates
19 Mar 2026to 30 Jul 2026
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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;

Who cannot join

  • 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;
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  • 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 locations and contacts

31 sites in 1 country.

31 sites in 1 country

China31 sites

  • Peking University First Hospita

    Beijing, Beijing Municipality, 100034

  • Peking University Third Hospital

    Beijing, Beijing Municipality, 100191

  • The first hospital of jilin university

    Changchun, Jilin, 130012

  • The First Hospital of Hunan University of Chinese Medicine

    Changsha, Hunan, 410007

  • Xiangya Hospital of Central South University

    Changsha, Hunan, 410008

  • Chengdu Second People's Hospital

    Chengdu, Sichuan, 610000

  • Sichuan Provincial People' s Hospital

    Chengdu, Sichuan, 610000

  • The First Affiliated Hospital of Fujian Medical University

    Fuzhou, Fujian, 350000

  • Southern Medical University Dermatology Hospital

    Guangzhou, Guangdong, 510091

  • Sun Yat-sen Memorial Hospital, Sun Yat-sen University

    Guangzhou, Guangdong, 510120

  • The Affiliated Hospital of Guizhou Medical University

    Guiyang, Guizhou, 550004

  • The General Hospital Of Hunan University Of Medicine

    Huaihua, Hunan, 41800

  • Jiaxing First Hospital

    Jiaxing, Zhejiang, 314001

  • Shandong First Medical University Affiliated Dermatology Hospital

    Jinan, Shandong, 250022

  • The First Affiliated Hospital of Kunming Medical University

    Kunming, Yunnan, 650032

  • The Second Affiliated Hospital of Henan University of science and technology

    Luoyang, Henan, 471000

  • The Affiliated Hospital of Southwest Medical University

    Luzhou, Sichuan, 646000

  • The first affiliated hospital of ningbo university

    Ningbo, Zhejiang, 315020

  • Shanghai Skin Disease Hospital

    Shanghai, Shanghai Municipality, 200443

  • The first hospital of china medical university

    Shenyang, Liaoning, 110001

  • The Second Hospital Of Hebei Medical University

    Shijiazhuang, Hebei, 050000

  • Shiyan Renmin Hospital

    Shiyan, Hubei, 442000

  • Tianjin Medical University General Hospital

    Tianjin, Tianjin Municipality, 300052

  • Tianjin Academy of Traditional Chinese Medicine Affiliated Hospital

    Tianjin, Tianjin Municipality, 300120

  • People's Hospital of Xinjiang Uygur Autonomous Region

    Ürümqi, Xinjiang, 830001

  • The First Affiliated Hospital of Xinjiang Medical University

    Ürümqi, Xinjiang, 830013

  • Renmin Hospital of Wuhan University

    Wuhan, Hubei, 430060

  • The Second Affiliated Hospital of Xi'an Jiaotong University

    Xi’an, Shanxi, 710061

  • Zhengzhou Central Hospital

    Zhengzhou, Henan, 450000

  • Henan Provincial People's Hospital

    Zhengzhou, Henan, 450003

  • The fifth Affiliated hospital of zhengzhou university

    Zhengzhou, Henan, 450052

Other trials in China

About this study

Official title: 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.

Being tested
TQH2929 Injections, TQH2929 Placebo
Medical subject headings
Psoriasis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TQH2929 InjectionsDrug

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

  • TQH2929 PlaceboDrug

    Placebo contains no active substance.

Study groups in NCT07314060
Study groupRoleWhat they receive
TQH2929 InjectionsExperimentalIntravenous infusion, single dose
Receives: Drug: TQH2929 Injections
TQH2929 PlaceboPlacebo comparatorIntravenous infusion, single dose
Receives: Drug: TQH2929 Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 1 week

Secondary outcomes (19)

  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.

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: 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

    Measured: 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.

    Measured: 4 weeks

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

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

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: 113 days or 169 days

  12. Abnormal clinical laboratory examination indicators

    Any laboratory abnormalities that occur during the test.

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: Through study completion, an average of half a year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Jan 2026
  2. Study start19 Mar 2026
  3. Primary completion30 Jul 2026
  4. Study completion30 Jul 2026

Why it stopped: Due to the company's strategic adjustment in product portfolio, this study has been voluntarily terminated.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
36 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07314060
Sponsor's protocol ID
TQH2929-II-01
Status last verified
Jul 2026
First submitted
15 Dec 2025
Last updated
3 Aug 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing TQH2929 Injections in people with Generalized Pustular Psoriasis, run by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. at 31 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 3 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 31 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: Due to the company's strategic adjustment in product portfolio, this study has been voluntarily terminated.). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of patients with a score of 0 for the pustule subterm (time frame: 1 week). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07314060.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Aug 2026.

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