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

February 12, 2025 updated by: Shanghai Huaota Biopharmaceutical Co., Ltd.

A Phase IIb, Long-Term Extension Study to Evaluate the Safety and Efficacy of HB0034 in the Treatment of Adult Subjects With Generalized Pustular Psoriasis

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).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Estimated)

33

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
      • Beijing, China
        • Recruiting
        • Peking University People's Hospital
      • Beijing, China
        • Recruiting
        • Peking University People's Hospital (PKUPH)
        • Principal Investigator:
          • Jianzhong zhang, PhD
        • Contact:
      • Hangzhou, China
        • Recruiting
        • The Second Affiliated Hospital Zhejiang University School of Medicine
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: HB0034
single-arm and all the patients would receive HB0034 300mg i.v. every other four weeks
Drug: HB0034
300mg, i.v. Q4W
Other Names:
  • Anti-IL-36R antibody,Recombinant Humanized anti-IL-36R Monoclonal antibody

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety endpoints include the proportion of subjects with TEAEs
Time Frame: 0-24 weeks
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 Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shanghai Huaota Biopharmaceutical Co., Ltd.

Investigators

  • Principal Investigator: Jianzhong Zhang, PhD, Peking University People's Hospital (PKUPH)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 2, 2024

Primary Completion (Estimated)

December 30, 2025

Study Completion (Estimated)

June 30, 2026

Study Registration Dates

First Submitted

June 22, 2024

First Submitted That Met QC Criteria

June 26, 2024

First Posted (Actual)

June 27, 2024

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 12, 2025

Last Verified

September 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HB0034-05

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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