NCT06391996Completed
Biologic Therapy for Generalized Pustular Psoriasis
Genetics-based Efficacy Analysis: Ustekinumab Versus Secukinumab for the Treatment of Generalized Pustular Psoriasis
Source: ClinicalTrials.gov · Last updated 30 Apr 2024
Brief summary (registry, in English)
The investigators aim to compare the efficacy and safety of secukinumab and ustekinumab in patients with generalized pustular psoriasis (GPP), and to explore the impact of genetic mutation types on clinical efficacy. The main questions the study aims to answer are: Is there a difference in the effectiveness of secukinumab and ustekinumab in the treatment of GPP? How is the safety of secukinumab and ustekinumab in the treatment of GPP? Does the type of genetic mutation in GPP patients affect the efficacy of secukinumab and ustekinumab? The investigators will compare patients treated with secukinumab to those treated with ustekinumab to see the difference in the effectiveness of the two drugs in treating GPP. Participants will: The investigators conducted a 48-week follow-up study on 65 participants who were admitted to the dermatology department of the First Affiliated Hospital of Fujian Medical University for GPP from July 2019 to December 2022. All participants underwent saliva-based genetic testing. Efficacy analyses were performed based on the scores of Generalized Pustular Psoriasis Area and Severity Index (GPPASI) and Generalized Pustular Psoriasis Physician Global Assessment (GPPGA) at week 0, 2, 4, 12, 24, and 48. Participants were also asked to report all adverse events (AEs) during follow-up.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 65 (actual)
- First submitted
- 20 Apr 2024
- Start date
- Jul 2019
- Primary completion date
- Dec 2022
- Lead sponsor
- Chao Ji
- Diseases
- Psoriasis
- NCT number
- NCT06391996
What you commit to
- Study type: Observational
- Participants enrolled: 65
- From Jul 2019 to the primary completion date, Dec 2022
- 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
- Patients with malignant tumors.
- Patients with a history of multiple drug allergies or a severe allergic constitution.
- Contraindications for ustekinumab/secukinumab, including active tuberculosis, active hepatitis B, hepatitis C, or inflammatory bowel disease.
- Patients who were severely immunocompromised.
Other
- Pregnant and lactating patients.
Who the study is looking for
- Patients meet the diagnostic criteria for GPP.
- Patients had an average GPPGA score of 3 or higher (moderate to severe disease).
- Patients had discontinued the treatment with non-biologic agents before they started the treatment with ustekinumab/secukinumab.
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 |
|---|---|---|---|
| First Affiliated Hospital of Fujian Medical University Coordinator of this site? Confirm its status | Fuzhou | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.