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
Status: Recruiting
Location: See all (3) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2/Phase 3
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).
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:
• 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
Locations
Other Locations
China
Peking University People's Hospital
RECRUITING
Beijing
Peking University People's Hospital (PKUPH)
RECRUITING
Beijing
The Second affiliated Hospital zhejiang University School of Medicine
RECRUITING
Hangzhou
Contact Information
Primary
Guodong Zhou
guodong.zhou@huaota.com
+86 13636638684
Backup
Qiaoxia Qian, Master
qiaoxia.qian@huaota.com
+86 18555690860
Time Frame
Start Date: 2024-09-02
Estimated Completion Date: 2026-06-30
Participants
Target number of participants: 33
Treatments
Experimental: HB0034
single-arm and all the patients would receive HB0034 300mg i.v. every other four weeks
Related Therapeutic Areas
Sponsors
Leads: Shanghai Huaota Biopharmaceutical Co., Ltd.