Evaluating HB0034 for treating severe flares of generalized pustular psoriasis

A Phase II, Multicenter, Double-blind, Randomized, Placebo Parallel-controlled Trial to Evaluate the Efficacy and Safety of HB0034 in Patients with GPP Presenting with an Acute Flare of Moderate to Severe Intensity

This study is testing if a new treatment called HB0034 can help people with severe flare-ups of generalized pustular psoriasis feel better.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 33 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Shanghai Huaota Biopharmaceutical Co., Ltd. (Industry-sponsored)
• Locations: 2 sites (Beijing and 1 other locations)
• Trial ID: NCT06231381 on ClinicalTrials.gov

What this trial studies

This phase II clinical trial is designed to assess the efficacy and safety of HB0034 in patients experiencing acute flares of moderate to severe generalized pustular psoriasis (GPP). Participants will be randomly assigned to receive either a single intravenous infusion of HB0034 or a placebo, with a 2:1 ratio. Following the infusion, patients will be hospitalized for at least 8 days for monitoring, and their health will be evaluated over a follow-up period of 12 to 20 weeks. The study aims to determine the drug's effectiveness in alleviating symptoms and improving patient outcomes.

Who should consider this trial

Good fit: Ideal candidates are adults experiencing an acute flare of moderate to severe GPP with specific clinical criteria.

Not a fit: Patients with drug-triggered pustulosis or other active inflammatory diseases requiring systemic immunosuppressants may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide significant relief and improved management for patients suffering from acute flares of generalized pustular psoriasis.

How similar studies have performed: While this approach is being tested in this specific context, similar studies have shown promise in treating other forms of psoriasis with novel therapies.

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.

Where this trial is running

Beijing and 1 other locations

• Peking University People's Hospital (PKUPH) — Beijing, China (Recruiting)
• Shanghai Huaota Biopharmaceutical Co., Ltd — Shanghai, China (Recruiting)

Study contacts

• Study coordinator: guodong zhou

Conditions Generalized Pustular Psoriasis