Long-Term Safety and Efficacy of HB0034 in Subjects With... | NCT06477536

Studies
Long-Term Safety and Efficacy of HB0034 in Subjects With Generalized Pustular Psoriasis

NCT06477536

Sponsor

Shanghai Huaota Biopharmaceutical Co., Ltd.

Status

Recruiting

Last Update Posted

Feb 14, 2025Actual

Enrollment

33Estimated

Phase

Phase 2Phase 3

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

Sep 2024

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2, 2024Actual

Primary Completion Date

Dec 30, 2025Estimated

Completion Date

Jun 30, 2026Estimated

First Submitted Date

Jun 22, 2024

First Submission Date that Met QC Criteria

Jun 26, 2024

First Posted Date

Jun 27, 2024Actual

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

Feb 12, 2025

Last Update Posted Date

Feb 14, 2025Actual

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 Phase IIb, long term extension study to evaluate the safety and efficacy of HB0034 in adult subjects with generalized pustular psoriasis (GPP).

Detailed Description

This study will also evaluate the pharmacokinetic (PK) profile of HB0034 and explore the immunogenicity of HB0034 in subjects with GPP

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 2Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

33Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
HB0034	Experimental	single-arm and all the patients would receive HB0034 300mg i.v. every other four weeks	Drug: HB0034

Interventions

Name	Type	Description	Arm Group Labels	Other Names
HB0034	Drug	300mg, i.v. Q4W	HB0034	Anti-IL-36R antibody,Recombinant Humanized anti-IL-36R Monoclonal antibody

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Safety endpoints include the proportion of subjects with TEAEs	The safety assessment includes monitoring for AEs, SAEs (including SAEs related to protocol procedures from signing of ICF until before the first dose of the study drug) from the first dose of the study drug to end of study (EOS) , as well as changes from baseline in laboratory tests, vital signs, physical examination, and 12-lead electrocardiogram (ECG).	0-24 weeks

Secondary Outcomes

Measure	Description	Time Frame
The recurrence of GPP flare during the study	The Proportion of patients who have at least once GPP flare during the study	0-24 weeks

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients participated in the preceding placebo-controlled Phase 2 study （HB0034-04）and completed at least the Week 12 visit of the HB0034-04 study
Subject must be a candidate for prolonged GPP treatment according to the Investigator's judgment
Men and women of reproductive age who have no parenting plans and are willing to use reliable contraception during the study period and for 6 months after the last dose of the study drug;
Patients who fully understand and voluntarily sign an ICF, and are willing and able to follow clinical study and subsequent visit schedules

Exclusion Criteria:

Patients who are experiencing GPP flare

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

Name	Role	Phone	Extension	Email
Guodong Zhou	Contact	+86 13636638684		guodong.zhou@huaota.com
Qiaoxia Qian, Master	Contact	+86 18555690860		qiaoxia.qian@huaota.com

Overall Officials

Name	Affiliation	Role
Jianzhong Zhang, PhD	Peking University People's Hospital (PKUPH)	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Peking University People's Hospital (PKUPH)	Recruiting	Beijing			China

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

Not provided