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 ).

Study Overview

• Status: Completed
• Conditions: Generalized Pustular Psoriasis
• Intervention / Treatment: Drug: HB0034

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 Type: Interventional
• Enrollment (Actual): 9
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: zhou guodong; Phone Number: +86 13636638684; Email: guodong.zhou@huaota.com
• Study Contact Backup: Name: Qian Qiaoxia; Phone Number: +86 18555690860; Email: qiaoxia.qian@huaota.com

Study Locations

• China
  • Shandong
    • Shandong, Shandong, China, 250000
      • Dermatology Hospital of Shandong First Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	90 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of Patients achieved GPPAG pustular 0/1 (pustular cleared or almost cleared)	efficacy outcome of investigational drug	12 weeks
Cmax	The maximum measured concentration of the analysis in plasma	12 weeks
AUC0-infinity	The area under the concentration-time curve of the analysis in plasma over the time interval from 0 extrapolated to infinity	12 weeks

Collaborators and Investigators

• Sponsor: Shanghai Huaota Biopharmaceutical Co., Ltd.
• Investigators: Principal Investigator: Zhang Furen, Doc., Shandong Provincial Dermatology Hospital

Study record dates

Study Major Dates

• Study Start (Actual): November 6, 2022
• Primary Completion (Actual): November 15, 2023
• Study Completion (Actual): January 10, 2024

Study Registration Dates

• First Submitted: August 22, 2022
• First Submitted That Met QC Criteria: August 22, 2022
• First Posted (Actual): August 23, 2022

Study Record Updates

• Last Update Posted (Actual): January 23, 2024
• Last Update Submitted That Met QC Criteria: January 21, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Skin Diseases, Papulosquamous; Psoriasis
• Other Study ID Numbers: HB0034-02

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No