Search / Trial NCT06231381

Efficacy and Safety of HB0034 in Patients with Generalized Pustular Psoriasis (GPP)

Launched by SHANGHAI HUAOTA BIOPHARMACEUTICAL CO., LTD. · Jan 29, 2024

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Trial Information

Current as of December 21, 2024

Recruiting

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called HB0034 for patients who have a condition known as Generalized Pustular Psoriasis (GPP), which causes painful, pus-filled bumps on the skin. Specifically, the trial is looking at how well HB0034 works and how safe it is for patients experiencing a severe flare-up of this condition. The trial is currently recruiting participants who are between the ages of 18 and 75 and are having moderate to severe symptoms, including a significant number of pustules covering at least 5% of their skin.

To be eligible for this trial, participants need to be experiencing a bad flare-up of GPP and agree to use reliable birth control if they are of reproductive age. They should not have certain other medical conditions or recent serious infections that could interfere with the study. If you participate, you will receive either the study drug or a placebo (a non-active treatment) and will be closely monitored by healthcare professionals throughout the trial. This helps ensure that the researchers can gather important information about the effectiveness and safety of HB0034 for treating GPP.

Gender

ALL

Eligibility criteria

  • 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.

About Shanghai Huaota Biopharmaceutical Co., Ltd.

Shanghai Huaota Biopharmaceutical Co., Ltd. is a leading biopharmaceutical company based in Shanghai, specializing in the research, development, and commercialization of innovative therapeutics. Committed to advancing healthcare, Huaota focuses on harnessing cutting-edge biotechnologies to address unmet medical needs across various therapeutic areas, including oncology, autoimmune diseases, and infectious diseases. With a robust pipeline of clinical trials, the company aims to deliver high-quality, effective treatment options while adhering to stringent regulatory standards and fostering collaborations within the global biopharmaceutical community.

Locations

Shanghai, , China

Beijing, , China

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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