| Eligibility |
Inclusion Criteria:
- Patients must be experiencing an acute GPP flare of moderate-to-severe intensity at
baseline, defined as:
1. A Generalized Pustular Psoriasis Physician Global Assessment (GPPGA) score of =
3;
2. New appearance or worsening of existing pustules, and a GPPGA pustulation
subscore of = 2;
3. = 5% Body Surface Area (BSA) covered with pustules.
- 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:
- Drug-triggered acute generalized exanthematous pustulosis (AGEP);
- Synovitis-acne-pustulosis-hyperostosis-osteitis syndrome (SAPHO);
- Other active inflammatory or autoimmune diseases requiring systemic treatment with
immunosuppressants, including but not limited to rheumatoid arthritis (RA), psoriatic
arthritis (PsA), systemic lupus erythematosus (SLE), inflammatory bowel disease, and
uveitis.
- Patients with an increased risk of infectious complications as assessed by the
investigator (e.g., a recent suppurative infection, any congenital or acquired
immunodeficiency, such as HIV infection, prior organ or stem cell transplantation);
- Patients who have received a live vaccine or investigational live vaccine within 6
weeks prior to the first dose of the study drug, or plan to receive a live vaccine or
participate in a clinical study of investigational live vaccine during the study
period or within 6 weeks after completion of administration of the study drug;
- Patients who have had a serious trauma or undergone a major surgery within 1 month
prior to the first dose of the study drug, or plan to undergo any elective surgery
during the study period;
- Patients with documented active or suspected malignancy or a history of malignancy
within 5 years prior to screening;
- Patients with a history of severe allergy, who have experienced grade 3-4 allergic
reactions when receiving other monoclonal antibodies, or those who are known to have
hypersensitivity to protein drugs, recombinant proteins, or HB0034 components;
- Subjects who are pregnant or breastfeeding, or those who have a positive pregnancy
test result. Breastfeeding female subjects who stop breastfeeding prior to the first
dose of the study drug until 16 weeks after the end of the trial will not be excluded;
- Patients who are currently participating in clinical trials or have participated in
clinical trials of any drug/device within 30 days (or 5 half-lives, whichever is
longer) prior to the first dose of the study drug;
- Patients expected to have poor compliance, such as those who are uncooperative, fail
to receive follow-up on time, and are unlikely to complete the study;
- Other reasons that the investigator considers it is inappropriate to participate in
the study.
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