Long-Term Safety and Efficacy of HB0034 in Subjects With Generalized Pustular Psoriasis
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
1 other identifier
interventional
33
1 country
3
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Sep 2024
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 22, 2024
CompletedFirst Posted
Study publicly available on registry
June 27, 2024
CompletedStudy Start
First participant enrolled
September 2, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 30, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2026
ExpectedFebruary 14, 2025
September 1, 2024
1.3 years
June 22, 2024
February 12, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
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 (1)
The recurrence of GPP flare during the study
0-24 weeks
Study Arms (1)
HB0034
EXPERIMENTALsingle-arm and all the patients would receive HB0034 300mg i.v. every other four weeks
Interventions
300mg, i.v. Q4W
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Patients who are experiencing GPP flare
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
Peking University People's Hospital (PKUPH)
Beijing, China
Peking University People's Hospital
Beijing, China
The Second affiliated Hospital zhejiang University School of Medicine
Hangzhou, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jianzhong Zhang, PhD
Peking University People's Hospital (PKUPH)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 22, 2024
First Posted
June 27, 2024
Study Start
September 2, 2024
Primary Completion
December 30, 2025
Study Completion (Estimated)
June 30, 2026
Last Updated
February 14, 2025
Record last verified: 2024-09