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RecruitingNCT07187817STEPSUpdated Jul 9, 2026

SEquential Treatment of PSoriasis With Biologics

An observational study in Psoriasis, sponsored by Royal United Hospitals Bath NHS Foundation Trust. Recruiting at 1 site in United Kingdom. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-09.

Sponsored by Royal United Hospitals Bath NHS Foundation Trust · Observational

From the registry’s dates

  • Primary completion was expected by Aug 2026, 3 months ago, but the record still lists the study as recruiting.
  • Started Oct 2025; still recruiting 1 year 1 month later.

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Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
366
Ages
18 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-14

Among 157 studies in Psoriasis with a site in United Kingdom — 9 open to participants now, 16 under way, 9 of them phase 3. Psoriasis · United Kingdom.

Planned enrollment
13th of 21
366 · median 412
Started
2025
with 4 others
Observational
21 of 157
4 open now
Primary completion
2026-08
later than 6 of 15 live
Registered
153rd of 157
by date

Among the 157 studies in Psoriasis with a site in United Kingdom, this one is the 13th largest by planned enrollment of the 21 observational ones that give a count, is one of 5 that started in 2025, is one of 21 observational ones, reaches primary completion later than 6 of the 15 other live ones, and was the 153rd registered.

Psoriasis

2,030 studies on the registry are indexed under Psoriasis; 276 are open to participants now.

Browse Psoriasis studies →

Open to participants now

9 of the 157 studies in Psoriasis with a site in United Kingdom are open now. Recruiting first, the newest first:

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All 9 open studies →

A study can be open while its sites in United Kingdom have not opened yet or have stopped. Only those recruiting at a site in United Kingdom →

Who these studies take

Of the 173 Psoriasis studies recruiting now, 91 (53%) set no upper age limit and 66 (38%) stop at 75 or younger; 25 take children under 18; 40 take healthy volunteers.

This study: 18 Years and older · all sexes · no healthy volunteers.

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02

Study summary

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

Read the detailed description

STEPS is a retrospective observational cohort study, which will evaluate previously obtained data that had been collected in the process of routine Dermatology appointments. NHS Dermatology centres from around the United Kingdom will be recruited as sites and will submit data on patients with psoriasis treated with biologic drugs (1st to 10th line), from looking through their previous medical notes. All data submitted will be anonymous, as no identifying information will be included in the submissions. An online survey will be developed on the online platform RedCAP to collect and store the data.

Each participant will have information submitted including demographic information like age and sex, as well as information about their psoriasis and treatments. The psoriasis scores (Psoriasis Area and Severity Index and Dermatology Life Quality Index) at baseline of each line of drug, and then at the 3 and 6 month follow up appointments for each line of drug, will be submitted. These measures will be used to determine if there was an improvement in psoriasis with each line of drug, if so what level of improvement, and to compare the response in the different lines of biologic. The hypothesis is that the response at 3 months to each line of biologic does not reduce with increasing lines of biologic after the 2nd line.

As all the information to be submitted has been previously obtained in routine clinics, no additional visits or changes to any medication or monitoring will be required for any participants.

The sample size calculation suggested that a minimum of 610 treatment courses (lines of biologic treatment) are needed to undertake a meaningful analysis, which equates to data on 366 patients. To account for missing data, which is inevitable with observational data, the aim is to recruit 7-8 sites, who will each submit data on 50 patients. The investigators aim for data submission to be completed within 6 months of the start of the study, and that analysis will take a further 6 months.

03

Conditions studied

  • Psoriasis

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Keywords

  • biologic
  • bdmard
  • tsdmard
  • biological agent
  • 3rd line
  • 4th line
  • switch
  • cycle
04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Participants taken from population who have been treated with biologics and targeted synthetic treatments in Dermatology departments at participating NHS sites.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Diagnosis of chronic plaque psoriasis by a Dermatology consultant
  • Prior treatment with biologic or targeted synthetic treatment (1 to 10 lines) for psoriasis in the United Kingdom

Exclusion criteria

Exclusion Criteria:

  • Diagnosis of other forms of psoriasis for example generalised pustular psoriasis
05

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
366 participants (estimated)
Patient registry
No

Groups and cohorts

  • 2nd Line Biologic

    Participants previously treated with 2 lines of biologic or targeted synthetic treatment for psoriasis.

  • 3rd+ Line Biologic

    Participants previously treated with 3 or more lines of biologic or targeted synthetic treatment for psoriasis.

06

What researchers measure

Primary outcomes

  1. PASI75

    75% improvement in Psoriasis Area and Severity Index (PASI)

    Time frame: 12-16 weeks and 6 months

Secondary outcomes

  1. PASI90

    90% improvement in PASI score

    Time frame: 12-16 weeks and 6 months

  2. PASI100

    100% improvement to PASI score

    Time frame: 12-16 weeks and 6 months

  3. PASI<2

    Achievement of a PASI score \<2

    Time frame: 12-16 weeks and 6 months

07

Study locations

1 of 1 sites recruiting
08

References and documents

Study documents

PDFs hosted by the registry, ClinicalTrials.gov.

Individual participant data

Plan to share: No — IPD (fully anonymised) would be shared upon reasonable request from other researchers.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Oct 2025 (actual). Primary completion is estimated for Aug 2026, 9 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 16, 2025
First posted
Sep 23, 2025
StartActual
Oct 14, 2025
Primary completionEst.
Aug 7, 2026
CompletionEst.
Aug 7, 2026
Last update
Jul 9, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jul 9, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07187817
Lead sponsor
Royal United Hospitals Bath NHS Foundation Trust
Collaborators
University of Bath, University of Leeds
Responsible party
Sponsor
First posted
Sep 23, 2025
Start date
Oct 14, 2025
Primary completion
Aug 7, 2026 (estimated)
Completion
Aug 7, 2026 (estimated)
Last update
Jul 9, 2026

Study contacts

Charlotte Gollins
Contact
charlotteelizabeth.gollins@nhs.net
01225 826192
Sarah Stratton
Contact
sarah.stratton@nhs.net
01225 826192

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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