HB0034 in Patients With Generalized Pustular Psoriasis (GPP)

NCT ID: NCT05512598

Last Updated: 2024-01-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

9 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-11-06

Study Completion Date

2024-01-10

Brief Summary

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

Detailed Description

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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.

Conditions

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Generalized Pustular Psoriasis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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HB0034

Recombinant Humanized Anti-IL-36R Monoclonal antibody

Group Type EXPERIMENTAL

HB0034

Intervention Type DRUG

HB0034, a single dose

Interventions

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HB0034

HB0034, a single dose

Intervention Type DRUG

Other Intervention Names

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

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Shanghai Huaota Biopharmaceutical Co., Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Zhang Furen, Doc.

Role: PRINCIPAL_INVESTIGATOR

Shandong Provincial Dermatology Hospital

Locations

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Dermatology Hospital of Shandong First Medical University

Shandong, Shandong, China

Site Status

Countries

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China

Other Identifiers

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HB0034-02

Identifier Type: -

Identifier Source: org_study_id

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