Overview

HB0034 in Patients With Generalized Pustular Psoriasis (GPP)

Status:
Not yet recruiting
Trial end date:
2023-12-30
Target enrollment:
0
Participant gender:
All
Summary
This is a study to evaluate the safety, tolerability, pharmacokinetics, and efficacy of HB0034 in adult patients with generalized pustular psoriasis (GPP ).
Phase:
Phase 1
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Shanghai Huaota Biopharmaceutical Co., Ltd.
Criteria
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