Generalized Pustular Psoriasis
Conditions
Brief summary
This is a study to evaluate the safety, tolerability, pharmacokinetics, and efficacy of HB0034 in adult patients with generalized pustular psoriasis (GPP ).
Detailed description
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.
Interventions
DRUGHB0034
HB0034, a single dose
Sponsors
Shanghai Huaota Biopharmaceutical Co., Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of patients with drug related adverse events | 90 days | An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of investigational drug |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of Patients achieved GPPAG pustular 0/1 (pustular cleared or almost cleared) | 12 weeks | efficacy outcome of investigational drug |
| Cmax | 12 weeks | The maximum measured concentration of the analysis in plasma |
| AUC0-infinity | 12 weeks | The area under the concentration-time curve of the analysis in plasma over the time interval from 0 extrapolated to infinity |
Countries
China
Outcome results
None listed