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Contact the study team using the details below to take part. If there are no contact details below please ask your doctor in the first instance.

Contact Information:

Dr Satveer Mahil
-
PLAN@kcl.ac.uk


Study Location:

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Be Part of Research - Trial Details - PLAN-psoriasis feasibility trial

PLAN-psoriasis feasibility trial

Recruiting

Open to: All Genders

Age: Mixed

Medical Conditions

Psoriasis being treated with biologic therapy and has been clear/nearly clear for at least 12 months


This information is provided directly by researchers, and we recognise that it isn't always easy to understand. We are working with researchers to improve the accessibility of this information. In some summaries, you may come across links to external websites. These websites will have more information to help you better understand the study.


More severe psoriasis is often treated with injection medicines called 'biologics', which target the immune system. Biologics are very effective at clearing psoriasis. People who have clear/nearly clear psoriasis currently take their treatment continuously and indefinitely. This can be burdensome (e.g. regular injections, hospital follow-up, drug side-effect risks including infections) and expensive. Personalised treatment plans may allow individuals to take the lowest amount of biologic needed to keep their psoriasis well-controlled. This would benefit patients and the NHS by reducing the risks and burden of treatment. The PLAN-psoriasis feasibility trial is investigating whether it is practical and acceptable (to patients, and healthcare professionals) to use personalised biologic treatment plans. The study will determine how feasible personalised treatment plans are for routine care. Findings will be used to design a larger study to look at the effectiveness of personalised treatment plans for the management of psoriasis.

Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.  

The recruitment start and end dates are as follows:

18 Nov 2024 01 May 2025

Participants will be allocated, by chance, to one of three treatment plans for 12-months:
1. Patient-led 'as needed' treatment: participants stop their biologic, and re-start it at the first sign of psoriasis appearing.
2. Therapeutic drug monitoring guided treatment: the concentration of drug in the blood is used to calculate how often participants inject their biologic.
3. Standard care: continue biologic treatment at the standard dose.

Participants will complete three-monthly online questionnaires about their skin, quality of life and mood, and take photographs of their skin. Blood tests will be taken at study visits at the study start and end. A self-taken blood sample will be arranged at 6-months. Participants can organise a face-to-face ‘ad hoc’ visit if they are concerned their psoriasis is worsening or if they are experiencing issues related to their psoriasis or treatment. Some will be invited to participate in an optional recorded interview about their experiences of the study.


Adults (aged 16 years old and over) with psoriasis who have had clear or nearly clear skin for 12 months or longer on their biologic treatment (risankizumab).

You can take part if:



You may not be able to take part if:


1. Adults receiving risankizumab primarily for psoriatic arthritis. Those receiving biologic therapy primarily for psoriasis and with controlled arthritis (no active joints or entheses) can be included.2. Any medical condition that, in the opinion of the investigator, may compromise the safety of the participant in the trial, compromise the evaluation of the trial outcomes, or reduce the participant’s ability to participate in the trial (e.g. where loss of control of psoriasis may be a risk to an individual’s future psoriasis management such as those with a history of unstable psoriasis or generalised pustular psoriasis). 3. Concomitant immune-modifying therapy or phototherapy.4. Currently participating in another interventional clinical trial.5. Inability to give written informed consent.


Below are the locations for where you can take part in the trial. Please note that not all sites may be open.

  • Guys Hospital
    Great Maze Pond
    London
    SE1 9RT

Possible benefits:
Participants may benefit from stopping or taking a lower dose of their biologic treatment. It may involve fewer injections and hospital follow-up visits, and they may experience fewer side effects of the medication. Some people find it rewarding to take part in medical research and appreciate the additional contact with the study team.
Involvement in the study will help to inform future research into treatment recommendations for people with psoriasis. The information and blood samples collected in the study can be used by the scientific community to understand psoriasis biology and treatment responses to improve the health and well-being of people with psoriasis.
Changing how often biologic injections are taken may increase the risk of a psoriasis flare. However, all participants will be closely monitored and if they report any flaring of psoriasis or concerns, an ad hoc follow-up face-to-face visit with our study doctors will take place quickly (within 5 working days), and their treatment may be adjusted if necessary. Participants will be asked to give up some of their time to attend study visits and complete study questionnaires and other study procedures (e.g. take photos of skin and donate blood samples). Blood tests can be uncomfortable and can cause some bruising or lightheadedness. On very rare occasions, infections can arise as a result of having blood taken. We will always try to take research blood samples when routine blood tests are taken.

Dr Satveer Mahil
-
PLAN@kcl.ac.uk



The study is sponsored by King's College London and funded by National Institute for Health and Care Research; National Psoriasis Foundation.




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Read full details for Trial ID: ISRCTN17922845

Or CPMS 60537

Last updated 25 November 2024

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