Actively Recruiting
Efficacy and Safety of HB0034 in Patients with Generalized Pustular Psoriasis (GPP)
Led by Shanghai Huaota Biopharmaceutical Co., Ltd. · Updated on 2025-03-19
33
Participants Needed
2
Research Sites
91 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is a phase II, multicenter, double-blind, randomized, placebo parallel-controlled clinical trial to evaluate the efficacy and safety of HB0034 in patients with generalized pustular psoriasis (GPP) presenting with an acute flare of moderate to severe intensity.
CONDITIONS
Official Title
Efficacy and Safety of HB0034 in Patients with Generalized Pustular Psoriasis (GPP)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients must be experiencing an acute GPP flare of moderate-to-severe intensity at baseline, defined as a GPPGA score of 63 or higher.
- New appearance or worsening of existing pustules with a GPPGA pustulation subscore of 2 or higher.
- At least 5% of body surface area covered with pustules.
- Men and women of reproductive age must have no parenting plans and agree to use reliable contraception during the study and for 6 months after the last dose.
- Patients must fully understand and voluntarily sign informed consent and be willing and able to follow study and visit schedules.
You will not qualify if you...
- Drug-triggered acute generalized exanthematous pustulosis (AGEP).
- Synovitis-acne-pustulosis-hyperostosis-osteitis syndrome (SAPHO).
- Active inflammatory or autoimmune diseases requiring systemic immunosuppressants, including rheumatoid arthritis, psoriatic arthritis, systemic lupus erythematosus, inflammatory bowel disease, or uveitis.
- Increased risk of infectious complications, such as recent suppurative infection, immunodeficiency including HIV, or prior organ/stem cell transplant.
- Receipt or planned receipt of live vaccines within 6 weeks before or during the study.
- Serious trauma or major surgery within 1 month prior to dosing or planned elective surgery during the study.
- Active or suspected malignancy or history of malignancy within 5 years prior to screening.
- History of severe allergies or grade 3-4 allergic reactions to monoclonal antibodies or hypersensitivity to protein drugs or HB0034 components.
- Pregnant or breastfeeding women, or positive pregnancy test.
- Participation in other clinical trials within 30 days prior to dosing.
- Expected poor compliance or inability to complete the study.
- Other reasons deemed inappropriate by the investigator.
AI-Screening
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Trial Site Locations
Total: 2 locations
1
Peking University People's Hospital (PKUPH)
Beijing, China
Actively Recruiting
2
Shanghai Huaota Biopharmaceutical Co., Ltd
Shanghai, China
Actively Recruiting
Research Team
G
guodong zhou
CONTACT
Q
Qiaoxia Qian, master
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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