HB0034 in Patients With Generalized Pustular Psoriasis (GPP)
Primary Purpose
Generalized Pustular Psoriasis
Status
Recruiting
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
HB0034
Sponsored by
About this trial
This is an interventional treatment trial for Generalized Pustular Psoriasis
Eligibility 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
Sites / Locations
- Dermatology Hospital of Shandong First Medical UniversityRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
HB0034
Arm Description
Recombinant Humanized Anti-IL-36R Monoclonal antibody
Outcomes
Primary Outcome Measures
Number of patients with drug related adverse events
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
Proportion of Patients achieved GPPAG pustular 0/1 (pustular cleared or almost cleared)
efficacy outcome of investigational drug
Cmax
The maximum measured concentration of the analysis in plasma
AUC0-infinity
The area under the concentration-time curve of the analysis in plasma over the time interval from 0 extrapolated to infinity
Full Information
NCT ID
NCT05512598
First Posted
August 22, 2022
Last Updated
November 9, 2022
Sponsor
Shanghai Huaota Biopharmaceutical Co., Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT05512598
Brief Title
HB0034 in Patients With Generalized Pustular Psoriasis (GPP)
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
Study Type
Interventional
2. Study Status
Record Verification Date
November 2022
Overall Recruitment Status
Recruiting
Study Start Date
November 6, 2022 (Actual)
Primary Completion Date
October 30, 2023 (Anticipated)
Study Completion Date
December 30, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Shanghai Huaota Biopharmaceutical Co., Ltd.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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 ).
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Generalized Pustular Psoriasis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
HB0034
Arm Type
Experimental
Arm Description
Recombinant Humanized Anti-IL-36R Monoclonal antibody
Intervention Type
Drug
Intervention Name(s)
HB0034
Other Intervention Name(s)
HB0034, a recombinant humanized anti-IL-36R IgG1 monoclonal antibody
Intervention Description
HB0034, a single dose
Primary Outcome Measure Information:
Title
Number of patients with drug related adverse events
Description
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of investigational drug
Time Frame
90 days
Secondary Outcome Measure Information:
Title
Proportion of Patients achieved GPPAG pustular 0/1 (pustular cleared or almost cleared)
Description
efficacy outcome of investigational drug
Time Frame
12 weeks
Title
Cmax
Description
The maximum measured concentration of the analysis in plasma
Time Frame
12 weeks
Title
AUC0-infinity
Description
The area under the concentration-time curve of the analysis in plasma over the time interval from 0 extrapolated to infinity
Time Frame
12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Zhou Guodong
Phone
+86 13636638684
Email
guodong.zhou@huaota.com
First Name & Middle Initial & Last Name or Official Title & Degree
Qian Qiaoxia
Phone
+86 18555690860
Email
qiaoxia.qian@huaota.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zhang Furen, Doc.
Organizational Affiliation
Shandong Provincial Dermatology Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dermatology Hospital of Shandong First Medical University
City
Shandong
State/Province
Shandong
ZIP/Postal Code
250000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yang Baoqi
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
HB0034 in Patients With Generalized Pustular Psoriasis (GPP)
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