NCT05512598CompletedPhase 1
HB0034 in Patients With Generalized Pustular Psoriasis (GPP)
Multi-centre, Open-label, Single-arm, Phase Ib Study to Evaluate the Safety, Pharmacokinetics, and Efficacy of a Single Dose of HB0034 in Patients Acute Generalized Pustular Psoriasis (GPP) Flare
Source: ClinicalTrials.gov · Last updated 23 Jan 2024
Brief summary (registry, in English)
This is a study to evaluate the safety, tolerability, pharmacokinetics, and efficacy of HB0034 in adult patients with generalized pustular psoriasis (GPP ).
- Status (registry)
- Completed
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 9 (actual)
- First submitted
- 22 Aug 2022
- Start date
- 6 Nov 2022
- Primary completion date
- 15 Nov 2023
- Lead sponsor
- Shanghai Huaota Biopharmaceutical Co., Ltd.
- Diseases
- Psoriasis
- NCT number
- NCT05512598
What you commit to
- Study type: Interventional · Phase 1
- Participants enrolled: 9
- From 6 Nov 2022 to the primary completion date, 15 Nov 2023
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- History of clinically significant opportunistic infection (e.g., invasive candidiasis or pneumocystis pneumonia)
Other
- Immediate life-threatening flare of Generalized Pustular Psoriasis or requiring intensive care treatment, according, to the judgment of the investigator. Life-threatening complications mainly include but are not limited to, cardiovascular/cytokine-driven shock, pulmonary distress
- Pregnant or Breasting feeding subject. Women with a positive pregnancy test.
- Ongoing use of prohibited psoriasis treatments
- Further exclusions criteria apply
Who the study is looking for
- Male or female patients, aged 18 to 75 years at screening
- A known and documented history of Generalized Pustular Psoriasis diagnosed with ERASPEN criteria
- Presenting with a moderate-severe flare of Generalized Pustular Psoriasis (GPP)
- Patients must be able to understand and sign a written informed consent document and complete study-related procedures and questionnaires.
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Dermatology Hospital of Shandong First Medical University Coordinator of this site? Confirm its status | Shandong | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.