HB0034 in Patients With Generalized Pustular Psoriasis (GPP)

Phase 1

Completed

• Conditions: Generalized Pustular Psoriasis
• Interventions: Drug: HB0034

• Registration Number: NCT05512598
• Lead Sponsor: Shanghai Huaota Biopharmaceutical Co., Ltd.

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.

Study Timeline

• Study First Submitted: 2022-08-22
• Study First Submitted QC: 2022-08-22
• Study First Posted: 2022-08-23
• Study Start: 2022-11-06
• Primary Completion: 2023-11-15
• Status Verified: 2024-01
• Study Completion: 2024-01-10
• Last Update Submitted: 2024-01-21
• Last Update Posted: 2024-01-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 9

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
HB0034	HB0034	Recombinant Humanized Anti-IL-36R Monoclonal antibody

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Proportion of Patients achieved GPPAG pustular 0/1 (pustular cleared or almost cleared)	12 weeks	efficacy outcome of investigational drug
Cmax	12 weeks	The maximum measured concentration of the analysis in plasma
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

Trial Locations

Locations (1)

Dermatology Hospital of Shandong First Medical University; 🇨🇳 Shandong, Shandong, China