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Clinical Trials/NCT07314060
NCT07314060
Recruiting
Phase 2

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

Chia Tai Tianqing Pharmaceutical Group Co., Ltd.31 sites in 1 country36 target enrollmentStarted: March 19, 2026Last updated:
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InterventionsTQH2929 InjectionsTQH2929 Placebo

Overview

Phase
Phase 2
Status
Recruiting
Enrollment
36
Locations
31
Primary Endpoint
Percentage of patients with a score of 0 for the pustule subterm
OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Eligibility Criteria

Ages
18 Years to 75 Years (Adult, Older Adult)
Sex
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

  • •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;

Arms & Interventions

TQH2929 Injections

Experimental

Intravenous infusion, single dose

Intervention: TQH2929 Injections (Drug)

TQH2929 Placebo

Placebo Comparator

Intravenous infusion, single dose

Intervention: TQH2929 Placebo (Drug)

Outcomes

Primary Outcomes

Percentage of patients with a score of 0 for the pustule subterm

Time Frame: 1 week

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.

Secondary Outcomes

  • 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)
  • Change from baseline in disease life quality index (DLQI)(4 weeks)
  • Serious Adverse Event (SAE)(113 days or 169 days)
  • 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)
  • Percentage of patients with pustule subterm achieving a score of 0(4 weeks)
  • Change from baseline in Psoriasis Symptom Scale (PSS) score(4 weeks)
  • Adverse Drug Event (AE)(113 days or 169 days)
  • Treatment-Emergent Adverse Events (TEAES)(113 days or 169 days)
  • Abnormal clinical laboratory examination indicators(113 days or 169 days)
  • Maximum Concentration (Cmax)(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)
  • Time of maximum concentration (Tmax)(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)
  • Area Under the Curve (AUC)(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)
  • Apparent Volume of Distribution(Vd/F)(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)
  • Apparent Clearance (CL/F)(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)
  • Plasma half-life time (t1/2)(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)
  • Anti-drug antibody (ADA)(Through study completion, an average of half a year)

Investigators

Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (31)

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