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

NCT ID: NCT06477536

Last Updated: 2025-02-14

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

RECRUITING

Clinical Phase

PHASE2/PHASE3

Total Enrollment

33 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-09-02

Study Completion Date

2026-06-30

Brief Summary

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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

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

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

single-arm and all the patients would receive HB0034 300mg i.v. every other four weeks

Group Type EXPERIMENTAL

HB0034

Intervention Type DRUG

300mg, i.v. Q4W

Interventions

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HB0034

300mg, i.v. Q4W

Intervention Type DRUG

Other Intervention Names

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Anti-IL-36R antibody,Recombinant Humanized anti-IL-36R Monoclonal antibody

Eligibility Criteria

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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
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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Jianzhong Zhang, PhD

Role: PRINCIPAL_INVESTIGATOR

Peking University People's Hospital (PKUPH)

Locations

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Peking University People's Hospital (PKUPH)

Beijing, , China

Site Status RECRUITING

Peking University People's Hospital

Beijing, , China

Site Status RECRUITING

The Second affiliated Hospital zhejiang University School of Medicine

Hangzhou, , China

Site Status RECRUITING

Countries

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China

Central Contacts

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Guodong Zhou

Role: CONTACT

+86 13636638684

Qiaoxia Qian, Master

Role: CONTACT

+86 18555690860

Facility Contacts

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Jianzhong zhang

Role: primary

+8618555690860

Xiaoyong Man, Phd

Role: primary

+86 18555690860

Other Identifiers

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HB0034-05

Identifier Type: -

Identifier Source: org_study_id

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