HB0034 in Patients With Generalized Pustular Psoriasis (GPP)

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

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.

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