Adjusting guselkumab dosing schedules for adults with plaque psoriasis
Real-Life Evaluation of Guselkumab Dosing Interval Adjustments. SPAcing-GUS
Centre Hospitalier Universitaire de Nice · NCT07430319
This project will see if adults with plaque psoriasis who are doing well on guselkumab can safely have their injections spaced farther apart than nine weeks.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Centre Hospitalier Universitaire de Nice (other) |
| Drugs / interventions | guselkumab, methotrexate |
| Locations | 1 site (Nice, Alpes Maritimes) |
| Trial ID | NCT07430319 on ClinicalTrials.gov |
What this trial studies
This is an observational, real-world study of adult patients receiving guselkumab for cutaneous plaque psoriasis, focusing on cases where dosing intervals have already been extended beyond nine weeks. Investigators will collect clinical scores (PASI and IGA) and treatment histories to describe durability of response after interval prolongation and reasons for extension. Patients treated primarily for joint disease or whose extension was driven by surgery, pregnancy, or infection are excluded to keep the analysis focused on dermatologic response. The design builds on prior findings that some "super-responders" can tolerate longer intervals, and aims to document outcomes in routine clinical practice.
Who should consider this trial
Good fit: Adults with cutaneous plaque psoriasis who are already receiving guselkumab with dosing intervals exceeding nine weeks and who have PASI and/or IGA scores recorded during visits are the ideal candidates.
Not a fit: Patients receiving guselkumab mainly for joint involvement, or whose dosing was extended because of surgery, pregnancy, or infection, or who lack PASI/IGA assessments are unlikely to gain useful insights from this study.
Why it matters
Potential benefit: If successful, this work could support less frequent injections for some patients, reducing clinic visits, cost, and treatment burden while maintaining skin control.
How similar studies have performed: The GUIDE trial suggested that "super-responders" could extend guselkumab dosing to 16-week intervals, so this study seeks to document similar interval adjustments in routine care.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * .Adult patients receiving guselkumab for cutaneous psoriasis. 2. * Guselkumab treatment with dosing intervals exceeding 9 weeks. Exclusion Criteria: * Patients receiving guselkumab primarily for joint involvement. * Patients for whom guselkumab dosing was extended due to surgery, pregnancy, or infection. * Patients for whom the PASI or IGA score was not assessed during visits
Where this trial is running
Nice, Alpes Maritimes
- CHU de Nice — Nice, Alpes Maritimes, France (RECRUITING)
Study contacts
- Study coordinator: Thierry PASSERON
- Email: passeron.t@chu-nice.fr
- Phone: 0492036225
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: Psoriasis