A Clinical Study of TQH2929 Injection in Treatment With Generalized Pustular Psoriasis (GPP)

NCT ID: NCT06433531

Last Updated: 2025-07-30

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE1
• Total Enrollment: 9 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-06-19
• Study Completion Date: 2025-12-31

Brief Summary

This study is a multicenter, single-group, open-label study to evaluate the safety and tolerability of TQH2929 injection at a dose of 900mg in adult subjects with active Generalized Pustular Psoriasis (GPP), and to preliminarily evaluate the efficacy.

Conditions

Generalized Pustular Psoriasis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

TQH2929 Injection (900 mg)

TQH2929 Injection is administered as a single dose.

Group Type: EXPERIMENTAL

TQH2929 Injection

Intervention Type: DRUG

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

Interventions

TQH2929 Injection

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

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Adults aged between 18 and 75 years (inclusive)，both male and female；
• A known and documented history of Generalized Pustular Psoriasis diagnosed with European Rare and Severe Psoriasis Expert Network (ERASPEN) criteria in 2017；
• Presenting with a moderate-severe flare of Generalized Pustular Psoriasis (GPP)
• Body mass index (BMI) within 18~36 kg/m2；
• Major organ function is good;
• Patients must be able to understand and sign a written informed consent document;
• Patients must be able to complete study-related procedures and questionnaires;
• Female and male subjects of childbearing age should agree to use contraceptive measures during the study period and within 6 months after the end of the study; Female subjects need to serum pregnancy pregnancy test within 7 days before study enrollment.

Exclusion Criteria

• Patients with primary plaque psoriasis vulgaris with pustules that are restricted to psoriatic plaques；
• Immediate life-threatening flare of Generalized Pustular Psoriasis or requiring intensive care treatment, according, to the judgment of the investigator；
• Computed Tomography of the chest shows active or occult tuberculosis or a history of contact with an open tuberculosis (TB) subject within the past 6 months. Subjects positive for tuber closes spot(T-SPOT) (or other tuberculosis diagnostic test) result;
• Active hepatitis during the screening period, or positive for hepatitis B surface antigen (HBsAg)；
• History of human immunodeficiency virus (HIV) infection, or positive HIV serological results at screening during screening；
• Positive antibodies to treponema pallidum during screening；
• History of serious infection leading to hospitalization or intravenous infusion of antibiotics or antiviral therapy within 3 months prior to baseline;
• Active systemic infections requiring systemic antibiotics or systemic antiviral therapy within 4 weeks prior to baseline;
• History of opportunistic infection and parasitic infection within 6 months prior to the screening period；
• History of herpes zoster infection within 2 months prior to baseline；
• Subject has known or suspected autoimmune disease;
• Receive major surgery within 4 weeks prior to the first dose;
• Subjects with any type of active malignancy or a history of malignancy (except cervical cancer or non-metastatic cutaneous squamous cell carcinoma, basal cell carcinoma and papillary thyroid carcinoma) that has been cured for more than 5 years prior to the screening period;
• Subjects have history of significant drug allergies；
• Use of the following medications within the prescribed time:

1. Receive topical drugs for the treatment of skin diseases within 1 weeks prior to baseline;

2. Receive systemic therapy within 4 weeks prior to baseline;

3. Receive regular phototherapy within 4 weeks prior to baseline;

4. Within 12 weeks prior to baseline, receive live (attenuated) vaccine;

5. Receive antibiotics and antivirals within 4 weeks prior to baseline.

• People who are alcoholic, drug addicts, and known drug dependents;
• Pregnant or Breasting feeding subject;
• Received a blood transfusion within 4 weeks prior to the first dose;
• Subject is unable to tolerate intravenous infusion administration;
• During the period of participation in this study, participants had planned surgical procedures;
• Have participated in clinical trials of other drugs or medical devices within 4 weeks prior to baseline;
• In the judgment of the investigator or sponsoring medical auditor, it is believed that there are any medical or psychiatric symptoms that put the subject at risk, interfere with participation in the study, or interfere with the interpretation of the results of the study.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Peking University First Hospital

Beijing, Beijing Municipality, China

Dermatology Hospital of Southern Medical Universitye

Guangzhou, Guangdong, China

The First Hospital of Hebei Medical University

Shijiazhuang, Hebei, China

The Second Hospital of Hebei Medical University

Shijiazhuang, Hebei, China

The First Hospital of China Medical University

Shenyang, Liaoning, China

Second People's Hospital of Chengdu

Chengdu, Sichuan, China

The Second Affiliated Hospital Zhejiang University School of Medicine

Hangzhou, Zhejiang, China

Countries

China

Other Identifiers

TQH2929-I-01 (Ib)

Identifier Type: -

Identifier Source: org_study_id