Evaluating the long-term safety and effectiveness of HB0034 for 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
PHASE2; PHASE3 · Shanghai Huaota Biopharmaceutical Co., Ltd. · NCT06477536
This study is testing a new treatment called HB0034 to see if it is safe and effective for adults with generalized pustular psoriasis who have already tried a different study.
Quick facts
| Phase | PHASE2; PHASE3 |
|---|---|
| Study type | Interventional |
| Enrollment | 33 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Shanghai Huaota Biopharmaceutical Co., Ltd. (industry) |
| Locations | 3 sites (Beijing and 2 other locations) |
| Trial ID | NCT06477536 on ClinicalTrials.gov |
What this trial studies
This clinical trial is a Phase IIb long-term extension study aimed at assessing the safety and efficacy of HB0034 in adult patients with generalized pustular psoriasis (GPP). The study will also investigate the pharmacokinetic profile of HB0034 and explore its immunogenicity in participants. Eligible patients must have previously participated in a placebo-controlled Phase 2 study and be candidates for prolonged treatment. The trial will monitor participants over an extended period to gather comprehensive data on the treatment's effects.
Who should consider this trial
Good fit: Ideal candidates are adults who have previously participated in the Phase 2 study and are suitable for long-term treatment of GPP.
Not a fit: Patients currently experiencing a flare of generalized pustular psoriasis may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new effective option for patients suffering from generalized pustular psoriasis.
How similar studies have performed: Other studies have shown promise in treating similar conditions, but the specific approach with HB0034 is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Beijing and 2 other locations
- Peking University People's Hospital (PKUPH) — Beijing, China (RECRUITING)
- Peking University People's Hospital — Beijing, China (RECRUITING)
- The Second affiliated Hospital zhejiang University School of Medicine — Hangzhou, China (RECRUITING)
Study contacts
- Principal investigator: Jianzhong Zhang, PhD — Peking University People's Hospital (PKUPH)
- Study coordinator: Guodong Zhou
- Email: guodong.zhou@huaota.com
- Phone: +86 13636638684
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Generalized Pustular Psoriasis