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HB0034 in Patients With Generalized Pustular Psoriasis (GPP)

Sponsor
Shanghai Huaota Biopharmaceutical Co., Ltd. (Industry)
Overall Status
Not yet recruiting
CT.gov ID
NCT05512598
Collaborator
(none)
10
Enrollment
1
Location
1
Arm
14
Anticipated Duration (Months)
0.7
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
Phase 1

Detailed 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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
10 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
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
Anticipated Study Start Date :
Oct 30, 2022
Anticipated Primary Completion Date :
Oct 30, 2022
Anticipated Study Completion Date :
Dec 30, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: HB0034

Recombinant Humanized Anti-IL-36R Monoclonal antibody

Drug: HB0034
HB0034, a single dose
Other Names:
  • HB0034, a recombinant humanized anti-IL-36R IgG1 monoclonal antibody

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Number of patients with drug related adverse events [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 Outcome Measures

    1. Proportion of Patients achieved GPPAG pustular 0/1 (pustular cleared or almost cleared) [12 weeks]

      efficacy outcome of investigational drug

    2. Cmax [12 weeks]

      The maximum measured concentration of the analysis in plasma

    3. AUC0-infinity [12 weeks]

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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 75 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Shandong Provincial Dermatology Hospital Shandong Shandong China 250000

    Sponsors and Collaborators

    • Shanghai Huaota Biopharmaceutical Co., Ltd.

    Investigators

    • Principal Investigator: Zhang Furen, Doc., Shandong Provincial Dermatology Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Shanghai Huaota Biopharmaceutical Co., Ltd.
    ClinicalTrials.gov Identifier:
    NCT05512598
    Other Study ID Numbers:
    • HB0034-02
    First Posted:
    Aug 23, 2022
    Last Update Posted:
    Aug 23, 2022
    Last Verified:
    Aug 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Psoriasis

    Study Results

    No Results Posted as of Aug 23, 2022