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

NCT06433531 | Active Not Recruiting Phase 1

• 1 other identifier: TQH2929-I-01 (Ib)
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 7

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

Outcome Measures

Primary Outcomes (4)

• Adverse events (AE)

  The occurrence of all adverse events (AE).

  From the first dose to 113 days after the last dose

• Serious adverse events (SAE)

  The occurrence of all serious adverse events (SAE).

  From the first dose to 113 days after the last dose

• Treatment-related adverse events(TRAE)

  The occurrence of all treatment-related adverse events(TRAE).

  From the first dose to 113 days after the last dose

• Clinical laboratory abnormalities

  Incidence of participants with clinical laboratory abnormalities

  From the first dose to 113 days after the last dose

Secondary Outcomes (15)

• Time to reach maximum observed serum concentration (Tmax)

  Single dose: within 1 hour (pre-dose), 0, 0.5, 1, 2, 6, 12, 24, 48, 72, 168, 336, 504, 672, 840, 1008, 1344, 1680, 2016, 2353, 2688 hours post-dose

• Maximum serum concentration (Cmax)

  Single dose: within 1 hour (pre-dose), 0, 0.5, 1, 2, 6, 12, 24, 48, 72, 168, 336, 504, 672, 840, 1008, 1344, 1680, 2016, 2353, 2688 hours post-dose

• Area Under the Concentration-Time Curve From Zero to Infinity (AUC [0-infinity])

  Single dose: within 1 hour (pre-dose), 0, 0.5, 1, 2, 6, 12, 24, 48, 72, 168, 336, 504, 672, 840, 1008, 1344, 1680, 2016, 2353, 2688 hours post-dose

• Area Under the Concentration-Time Curve From 0 to Last Observation (AUC [0-t])

  Single dose: within 1 hour (pre-dose), 0, 0.5, 1, 2, 6, 12, 24, 48, 72, 168, 336, 504, 672, 840, 1008, 1344, 1680, 2016, 2353, 2688 hours post-dose

• Apparent volume of distribution (Vd/F)

  Single dose: within 1 hour (pre-dose), 0, 0.5, 1, 2, 6, 12, 24, 48, 72, 168, 336, 504, 672, 840, 1008, 1344, 1680, 2016, 2353, 2688 hours post-dose

Study Arms (1)

TQH2929 Injection (900 mg)

EXPERIMENTAL

TQH2929 Injection is administered as a single dose.

Drug: TQH2929 Injection

Interventions

TQH2929 Injection DRUG

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

TQH2929 Injection (900 mg)

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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:

Sponsors & Collaborators

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

Study Sites (7)

Peking University First Hospital

Beijing, Beijing Municipality, 100871, China

Location

Dermatology Hospital of Southern Medical Universitye

Guangzhou, Guangdong, 510091, China

Location

The First Hospital of Hebei Medical University

Shijiazhuang, Hebei, 050000, China

Location

The Second Hospital of Hebei Medical University

Shijiazhuang, Hebei, 050000, China

Location

The First Hospital of China Medical University

Shenyang, Liaoning, 110000, China

Location

Second People's Hospital of Chengdu

Chengdu, Sichuan, 610052, China

Location

The Second Affiliated Hospital Zhejiang University School of Medicine

Hangzhou, Zhejiang, 310000, China

Location

MeSH Terms

Conditions

Psoriasis

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 23, 2024
• First Posted: May 29, 2024
• Study Start: June 19, 2024
• Primary Completion: July 8, 2025
• Study Completion: December 1, 2025
• Last Updated: July 30, 2025

Record last verified: 2025-07

Locations

CN (7)