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Completed

NCT Number: NCT05512598

HB0034 in Patients With Generalized Pustular Psoriasis (GPP)

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

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Key information

Conditions

Generalized Pustular Psoriasis Psoriasis Skin Diseases Skin Diseases, Papulosquamous Skin and Connective Tissue Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Dermatology Hospital of Shandong First Medical University

Shandong, 250000, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

HB0034

Drug

HB0034, a single dose

Other names: HB0034, a recombinant humanized anti-IL-36R IgG1 monoclonal antibody

Primary outcomes

  1. Number of patients with drug related adverse events

    Time frame: 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 outcomes

  1. Proportion of Patients achieved GPPAG pustular 0/1 (pustular cleared or almost cleared)

    Time frame: 12 weeks

    efficacy outcome of investigational drug

  2. Cmax

    Time frame: 12 weeks

    The maximum measured concentration of the analysis in plasma

  3. AUC0-infinity

    Time frame: 12 weeks

    The area under the concentration-time curve of the analysis in plasma over the time interval from 0 extrapolated to infinity

Sponsors and collaborators

Lead sponsor

Shanghai Huaota Biopharmaceutical Co., Ltd.

Industry

Registry information

Official study 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

Important dates

Study start
2022
Primary completion
2023
Study completion
2024
First posted
Aug 23, 2022
Registry last updated
Jan 23, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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