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

NCT07314060 | Recruiting Phase 2

• 1 other identifier: TQH2929-II-01
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 32

Brief 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.

Conditions

Generalized Pustular Psoriasis

Outcome Measures

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.

  1 week

Secondary Outcomes (19)

• Percentage of patients with a Generalized Pustular Psoriasis Physician Global Assessment(GPPGA) total score of 0 or 1

  1 week and 4 weeks

• Percentage change from baseline in Generalized Pustular Psoriasis Area and Severity Index (GPPASI) total score

  1 week and 4 weeks

• Change from baseline in Generalized Pustular Psoriasis Area and Severity Index(GPPASI) total score

  1 week and 4 weeks

• Percentage of patients with Generalized Pustular Psoriasis Area and Severity Index(GPPASI) 50

  1 week and 4 weeks

• Percentage of patients with Generalized Pustular Psoriasis Area and Severity Index(GPPASI) 75

  1 week and 4 weeks

Study Arms (2)

TQH2929 Injections

EXPERIMENTAL

Intravenous infusion, single dose

Drug: TQH2929 Injections

TQH2929 Placebo

PLACEBO COMPARATOR

Intravenous infusion, single dose

Drug: TQH2929 Placebo

Interventions

TQH2929 Placebo DRUG

Placebo contains no active substance.

TQH2929 Placebo

TQH2929 Injections DRUG

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

TQH2929 Injections

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify 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 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;

You may not qualify 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 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;

Sponsors & Collaborators

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

Study Sites (32)

Peking University First Hospita

Beijing, Beijing Municipality, 100034, China

RECRUITING

Peking University Third Hospital

Beijing, Beijing Municipality, 100191, China

NOT YET RECRUITING

The First Affiliated Hospital of Fujian Medical University

Fuzhou, Fujian, 350000, China

NOT YET RECRUITING

Southern Medical University Dermatology Hospital

Guangzhou, Guangdong, 510091, China

NOT YET RECRUITING

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

Guangzhou, Guangdong, 510120, China

NOT YET RECRUITING

The Affiliated Hospital of Guizhou Medical University

Guiyang, Guizhou, 550004, China

NOT YET RECRUITING

The Second Hospital Of Hebei Medical University

Shijiazhuang, Hebei, 050000, China

NOT YET RECRUITING

The Second Affiliated Hospital of Henan University of science and technology

Luoyang, Henan, 471000, China

NOT YET RECRUITING

Zhengzhou Central Hospital

Zhengzhou, Henan, 450000, China

NOT YET RECRUITING

Henan Provincial People's Hospital

Zhengzhou, Henan, 450003, China

NOT YET RECRUITING

The fifth Affiliated hospital of zhengzhou university

Zhengzhou, Henan, 450052, China

NOT YET RECRUITING

Shiyan Renmin Hospital

Shiyan, Hubei, 442000, China

NOT YET RECRUITING

Renmin Hospital of Wuhan University

Wuhan, Hubei, 430060, China

NOT YET RECRUITING

The First Hospital of Hunan University of Chinese Medicine

Changsha, Hunan, 410007, China

NOT YET RECRUITING

Xiangya Hospital of Central South University

Changsha, Hunan, 410008, China

NOT YET RECRUITING

The General Hospital Of Hunan University Of Medicine

Huaihua, Hunan, 41800, China

NOT YET RECRUITING

The first hospital of jilin university

Changchun, Jilin, 130012, China

NOT YET RECRUITING

The first hospital of china medical university

Shenyang, Liaoning, 110001, China

NOT YET RECRUITING

Shandong First Medical University Affiliated Dermatology Hospital

Jinan, Shandong, 250022, China

NOT YET RECRUITING

Shanghai Skin Disease Hospital

Shanghai, Shanghai Municipality, 200443, China

NOT YET RECRUITING

The Second Affiliated Hospital of Xi'an Jiaotong University

Xi’an, Shanxi, 710061, China

NOT YET RECRUITING

Chengdu Second People's Hospital

Chengdu, Sichuan, 610000, China

NOT YET RECRUITING

Sichuan Provincial People' s Hospital

Chengdu, Sichuan, 610000, China

NOT YET RECRUITING

The Affiliated Hospital of Southwest Medical University

Luzhou, Sichuan, 646000, China

NOT YET RECRUITING

The Affiliated Hospital of Southwest Medical University

Luzhou, Sichuan, 646000, China

NOT YET RECRUITING

Tianjin Medical University General Hospital

Tianjin, Tianjin Municipality, 300052, China

NOT YET RECRUITING

Tianjin Academy of Traditional Chinese Medicine Affiliated Hospital

Tianjin, Tianjin Municipality, 300120, China

NOT YET RECRUITING

People's Hospital of Xinjiang Uygur Autonomous Region

Ürümqi, Xinjiang, 830001, China

NOT YET RECRUITING

The First Affiliated Hospital of Xinjiang Medical University

Ürümqi, Xinjiang, 830013, China

NOT YET RECRUITING

The First Affiliated Hospital of Kunming Medical University

Kunming, Yunnan, 650032, China

NOT YET RECRUITING

Jiaxing First Hospital

Jiaxing, Zhejiang, 314001, China

NOT YET RECRUITING

The first affiliated hospital of ningbo university

Ningbo, Zhejiang, 315020, China

NOT YET RECRUITING

MeSH Terms

Conditions

Psoriasis

Condition Hierarchy (Ancestors)

Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Central Study Contacts

Hang Li, Doctor

CONTACT

13693058190; drlihang@126.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 15, 2025
• First Posted: January 2, 2026
• Study Start: March 19, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): July 1, 2027
• Last Updated: March 24, 2026

Record last verified: 2025-10

Locations

CN (32)