SEquential Treatment of PSoriasis With Biologics
Study acronym: STEPS
StatusRecruiting
PhaseNot specified
Started2025-10-14
View on ClinicalTrials.gov ↗
Record status
This record was last updated July 9, 2026 (before its estimated August 7, 2026 completion). Its status may not reflect the trial's current state.
Amendment history
2026-07-08
notable
Study Status v3
Primary completion pushed: 2026-05-05 → 2026-08-07
Completion pushed: 2026-05-05 → 2026-08-07
2026-02-12
minor
Study Status v2
Primary completion date2025-12-31→2026-05-05
Completion date2026-04-02→2026-05-05
2025-11-20
minor
Study Status, Study Description, Eligibility v1
Completion date2025-12-31→2026-04-02
Start dateestimated 2025-09-22→confirmed 2025-10-14
Study description+1 characters
[...] to compare the response in the different lines of biologic.
OurThe hypothesis is that the response at 3 months to each line of [...] cation or monitoring will be required for any participants.
OurThe sample size calculation has suggested that a minimum of 610 treatment courses (lines of [...] missing data, which is inevitable with observational data, we willthe aim is to recruit 7-8 sites, who will each submit data on 50 patients.
OurThe investigators aim is thatfor data submission shouldto be completed within 6 months of the start of the study, and that analysis will take a further 6 months.
2025-09-16
minor
Original filing
12 trials monitored
See 2 trials at risk
418 trials monitored
See 17 trials at risk
Psoriasis is a common skin condition that leads to patches of scaled skin which can be inflamed, sore and itchy. It can affect any area of skin on the body, as well as nails, and can be widespread and severe. Over the past 20 years, many new treatments have been developed and approved for severe psoriasis. Most of these newer treatments are given by injection and, as a group, are known as biologics. Many people respond well to biologics and have a meaningful improvement in their condition. There is a smaller proportion of people who do not respond well, or develop side effects, and so must switch drugs to try and improve their condition. In some cases, people need multiple lines of biologic treatment. Currently very little is understood about how well people respond when they are treated with three or more biologics in a row, as very few trials have been done in these cases.
This study aims to use data from people who have already been treated with biologics by their Dermatology teams in the NHS and use the information obtained during their normal clinic appointments to investigate this question. The investigators will assess how well people respond to each line of biologic drug (1st to 10th). They will look at whether people respond as well or less well over time, the more biologics they have. People can be included in the research if they are 18 or over and have been treated with a biologic for psoriasis in participating hospitals in the NHS in England. In this study the investigators are assessing data from events that have previously happened, and so no extra visits are required
| NCT Number |
NCT07187817 |
| Lead Sponsor |
Royal United Hospitals Bath NHS Foundation Trust
Collaborators: University of Bath, University of Leeds |
| Conditions |
Psoriasis |
| Enrollment |
366 participants |
| Start Date |
2025-10-14 |
| Primary Completion |
2026-08-07 (estimated) |
| Study Completion |
2026-08-07 (estimated) |
| Updated on ClinicalTrials.gov |
2026-07-09 |