HB0034 in Patients With Generalized Pustular Psoriasis (GPP)

Generalized Pustular Psoriasis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05512598
• Other study ID #: HB0034-02
• Status: Completed
• Phase: Phase 1
• Start date: November 6, 2022
• Est. completion date: January 10, 2024

Study information

• Verified date: January 2024
• Source: Shanghai Huaota Biopharmaceutical Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 9
• Est. completion date: January 10, 2024
• Est. primary completion date: November 15, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Generalized Pustular Psoriasis
• Psoriasis

Intervention

Drug:
• HB0034
HB0034, a single dose

Locations

Country	Name	City	State
China	Dermatology Hospital of Shandong First Medical University	Shandong	Shandong

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Huaota Biopharmaceutical Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Proportion of Patients achieved GPPAG pustular 0/1 (pustular cleared or almost cleared)	efficacy outcome of investigational drug	12 weeks
Secondary	Cmax	The maximum measured concentration of the analysis in plasma	12 weeks
Secondary	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