HB0034 in Patients With Generalized Pustular Psoriasis (GPP)

Shanghai Huaota Biopharmaceutical Co., Ltd.9 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Generalized Pustular Psoriasis

Interventions

HB0034DRUG

HB0034, a single dose

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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

Locations (1)

Dermatology Hospital of Shandong First Medical University

Shandong, Shandong, China

Outcomes

Primary Outcomes

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

Time frame: 90 days

Secondary Outcomes

Proportion of Patients achieved GPPAG pustular 0/1 (pustular cleared or almost cleared)

efficacy outcome of investigational drug

Time frame: 12 weeks

Cmax

The maximum measured concentration of the analysis in plasma

Time frame: 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

Time frame: 12 weeks

Data from ClinicalTrials.gov

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