HB0034 in Patients With Generalized Pustular Psoriasis (GPP) | NCT05512598

Studies
HB0034 in Patients With Generalized Pustular Psoriasis (GPP)

NCT05512598

Sponsor

Shanghai Huaota Biopharmaceutical Co., Ltd.

Status

Completed

Last Update Posted

Jan 23, 2024Actual

Enrollment

9Actual

Phase

Phase 1

Conditions

Generalized Pustular Psoriasis

Interventions

HB0034

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2024

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 6, 2022Actual

Primary Completion Date

Nov 15, 2023Actual

Completion Date

Jan 10, 2024Actual

First Submitted Date

Aug 22, 2022

First Submission Date that Met QC Criteria

Aug 22, 2022

First Posted Date

Aug 23, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 21, 2024

Last Update Posted Date

Jan 23, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

9Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
HB0034	Experimental	Recombinant Humanized Anti-IL-36R Monoclonal antibody	Drug: HB0034

Interventions

Name	Type	Description	Arm Group Labels	Other Names
HB0034	Drug	HB0034, a single dose	HB0034	HB0034, a recombinant humanized anti-IL-36R IgG1 monoclonal antibody

Outcomes Module

Primary Outcomes

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 Outcomes

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

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Zhang Furen, Doc.	Shandong Provincial Dermatology Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Dermatology Hospital of Shandong First Medical University		Shandong	Shandong	250000	China

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D011565	Psoriasis

Ancestor Terms

ID	Term
D017444	Skin Diseases, Papulosquamous
D012871	Skin Diseases
D017437	Skin and Connective Tissue Diseases

Browse Leaves

Not provided

Browse Branches

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