HB0034 in Patients With Generalized Pustular Psoriasis (GPP)

Study Overview
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Brief Summary
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This is a study to evaluate the safety, tolerability, pharmacokinetics, and efficacy of HB0034 in adult patients with generalized pustular psoriasis (GPP ).

Detailed Description
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This is an open-label, multicenter, phase Ib exploratory study to evaluate the safety, tolerability, pharmacokinetics, and efficacy of HB0034 in adult patients presenting moderate-severe generalized pustular psoriasis (GPP ) flare.

Official Title
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Multi-centre, Open-label, Single-arm, Phase Ib Study to Evaluate the Safety, Pharmacokinetics, and Efficacy of a Single Dose of HB0034 in Patients Acute Generalized Pustular Psoriasis (GPP) Flare

Conditions
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Generalized Pustular Psoriasis

Intervention / Treatment
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* Drug: HB0034


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female patients, aged 18 to 75 years at screening A known and documented history of Generalized Pustular Psoriasis diagnosed with ERASPEN criteria Presenting with a moderate-severe flare of Generalized Pustular Psoriasis (GPP) Patients must be able to understand and sign a written informed consent document and complete study-related procedures and questionnaires. Exclusion Criteria: Immediate life-threatening flare of Generalized Pustular Psoriasis or requiring intensive care treatment, according, to the judgment of the investigator. Life-threatening complications mainly include but are not limited to, cardiovascular/cytokine-driven shock, pulmonary distress History of clinically significant opportunistic infection (e.g., invasive candidiasis or pneumocystis pneumonia) Pregnant or Breasting feeding subject. Women with a positive pregnancy test. Ongoing use of prohibited psoriasis treatments Further exclusions criteria apply

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: HB0034<br>Recombinant Humanized Anti-IL-36R Monoclonal antibody | Drug: HB0034<br>* HB0034, a single dose<br>* Other names: HB0034, a recombinant humanized anti-IL-36R IgG1 monoclonal antibody;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients with drug related adverse events | An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of investigational drug | 90 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of Patients achieved GPPAG pustular 0/1 (pustular cleared or almost cleared) | efficacy outcome of investigational drug | 12 weeks | 
| Cmax | The maximum measured concentration of the analysis in plasma | 12 weeks | 
| AUC0-infinity | The area under the concentration-time curve of the analysis in plasma over the time interval from 0 extrapolated to infinity | 12 weeks |