HB0034 in Patients With Generalized Pustular Psoriasis (GPP)

Shanghai Huaota Biopharmaceutical

Status and phase

Completed

Phase 1

Conditions

Generalized Pustular Psoriasis

Treatments

Drug: HB0034

Study type

Interventional

Funder types

Industry

Identifiers

NCT05512598

HB0034-02

Details and patient eligibility

About

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

Full 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.

Enrollment

9 patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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