RECRUITINGPhase 2 / Phase 3INTERVENTIONAL
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
About This Trial
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).
Who May Be Eligible (Plain English)
Who May Qualify:
- 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
Who Should NOT Join This Trial:
- Patients who are experiencing GPP flare
Always talk to your doctor about whether this trial is right for you.
Original Eligibility Criteria
View original clinical language
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
Treatments Being Tested
DRUG
HB0034
300mg, i.v. Q4W
Locations (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