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Contact Information:

Dr Andrew Pink
+44 (0)207 188 7188 ext 5156
BEACON@kcl.ac.uk


More information about this study, what is involved and how to take part can be found on the study website.

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Be Part of Research - Trial Details - Best systemic treatments for adults with atopic eczema over the long term (BEACON)
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Best systemic treatments for adults with atopic eczema over the long term (BEACON)

Recruiting

Open to: All Genders

Age: Adult

Oxford Nottingham London Dundee London Salford London Dudley London Exeter London Newcastle upon Tyne

Medical Conditions

Atopic dermatitis

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.


Eczema is a skin disease affecting 1 in 20 UK adults. People with eczema itch constantly and the damaged inflamed skin often gets infected, leading to disfigurement, low mood and a negative impact on quality of life. More severe eczema requires ‘systemic’ treatments such as methotrexate and ciclosporin that dampen down the immune system. Recently, treatments have been developed to block signals from certain immune cells particularly important in eczema, including dupilumab and abrocitinib. These treatments are available on the NHS but so far studies have not compared them against standard treatments. The aim of this study is to compare the effectiveness, tolerability, and cost of dupilumab, methotrexate, and abrocitinib to ciclosporin.

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:

03 Jan 2024 31 May 2026

Participants will get either oral ciclosporin, methotrexate self-injection, dupilumab self-injection or oral abrocitinib for up to 1 year. Patients will know which treatment they are on but the person assessing the eczema will not know to make sure we come up with a truthful answer. Participants will complete questionnaires between visits about any side effects and whether they have used any other NHS services. There will be an option to increase the treatment dose after 3 months for some study arms, and at 6 months the treatment can be changed if it is not working sufficiently. The researchers will judge the success of the different treatments by looking at participants’ skin using a reliable eczema score and by asking participants about things like itching and quality of life. They will collect information about side effects and whether the treatments are cost-effective.


Patients aged 18 years and over with moderate to severe eczema

You can take part if:



You may not be able to take part if:


Current exclusion criteria as of 06/03/2025:1. Active dermatologic conditions that may confound the diagnosis of atopic eczema or interfere with assessment of treatment.2. Prior exposure to any of the systemic therapies being investigated in the trial or those with a similar mechanism of action to the systemic therapies being investigated in the trial.3. Receipt of any of the following:a. Phototherapy (UVB TL01, UVB, PUVA, UVA1), tanning beds, oral or parenteral traditional Chinese medicine or oral systemic immunosuppressant/ immunomodulatory agent that can help eczema (including but not limited to prednisolone, azathioprine, mycophenolate mofetil, tacrolimus, Janus kinase (JAK) inhibitor or phosphodiesterase 4 inhibitor) within 4 weeks prior to randomisation.b. Biologic therapy for eczema (including but not limited to amlitelimab, rocatinlimab and nemolizumab) within 3 months prior to randomisation.c. Receipt of a cell-depleting agent (e.g. rituximab, alemtuzumab, cyclophosphamide, chlorambucil) for 6 months prior to randomisation or until lymphocyte count returns to normal (whichever is longer)4. Any medical condition that, in the opinion of the investigator, may compromise the safety of the participant in the trial, interfere with the evaluation of the IMP, or reduce the participant’s ability to participate in the trial.5. Receipt of live/ live attenuated vaccine 30 days prior to the baseline visit date or expected need of live / live attenuated vaccination during the trial.6. Participating in another clinical trial.7. Women of child-bearing potential at risk of pregnancy during the trial (i.e. sexually active women not on effective contraception)8. Women who are pregnant or breastfeeding.

Drug-specific exclusion criteria:Please note, as long as a participant is eligible to take ciclosporin (control arm) and at least one of the other trial treatments they can be randomised (i.e. they can meet exclusion criteria for one or more of the other treatments and still be randomised).

Ciclosporin1. Any contraindication to ciclosporin according to standard clinical care and/or the opinion of the investigator

Dupilumab1. Any contraindication to dupilumab according to standard clinical care and/or the opinion of the investigator

Methotrexate1. Any contraindication to methotrexate according to standard clinical care and/or the opinion of the investigator2. Men and women planning conception within 6 months (cannot conceive for a minimum of 6 months after stopping methotrexate and need to continue on effective contraception through that period)

Abrocitinib1. Any contraindication to abrocitinib according to standard clinical care and/or the opinion of the investigator.

Note, as per license, abrocitinib should only be used if no suitable treatment alternatives are available in patients:1. 65 years of age and older2. Patients with a history of atherosclerotic cardiovascular disease or other cardiovascular risk factors (such as current or past long-time smokers)3. Patients with malignancy risk factors (e.g. current malignancy or history of malignancy)

Note, the need for a shingles vaccination (Shingrix) should be considered based on any specific risk factors relevant to the individual participant and up-to-date formal Green Book guidance: Immunisation against infectious disease - GOV.UK (https://www.gov.uk).

Previous exclusion criteria:1. Active dermatologic conditions that may confound the diagnosis of atopic eczema or interfere with assessment of treatment2. Prior exposure to any of the systemic therapies being investigated in the trial3. Receipt of any of the following:3.1. Phototherapy (UVB TL01, UVB, PUVA, UVA1), tanning beds, oral or parenteral traditional Chinese medicine or oral systemic immunosuppressant/ immunomodulatory agent that can help eczema (including but not limited to prednisolone, azathioprine, mycophenolate mofetil, tacrolimus, Janus kinase (JAK) inhibitor, or phosphodiesterase 4 inhibitor) within 4 weeks prior to randomisation3.2. Biologic therapy for eczema (including but not limited to tralokinumab, lebrikizumab and nemolizumab) within 3 months prior to randomisation3.3. Receipt of a cell-depleting agent (e.g. rituximab, alemtuzumab, cyclophosphamide, chlorambucil) for 6 months prior to randomisation or until lymphocyte count returns to normal (whichever is longer)4. Any medical condition that, in the opinion of the investigator, may compromise the safety of the participant in the trial, interfere with evaluation of the IMP, or reduce the participant’s ability to participate in the trial5. Receipt of live/live attenuated vaccine 30 days prior to the baseline visit date or expected need of live/live attenuated vaccination during the trial.6. Participating in another clinical trial7. Women of child-bearing potential at risk of pregnancy during the trial (i.e. sexually active women not on effective contraception)8. Women who are pregnant or breastfeeding

Drug-specific exclusion criteria:Please note, as long as a participant is eligible to take ciclosporin (control arm) and at least one of the other trial treatments they can be randomised (i.e. they can meet exclusion criteria for one of methotrexate or dupilumab and still be randomised).

Ciclosporin 1. Any contraindication to ciclosporin according to standard clinical care and/or the opinion of the investigator

Dupilumab 1. Any contraindication to dupilumab according to standard clinical care and/or the opinion of the investigator

Methotrexate 1. Any contraindication to methotrexate according to standard clinical care and/or the opinion of the investigator2. Men and women planning conception within 6 months (cannot conceive for a minimum of 6 months after stopping methotrexate and need to continue on effective contraception through that period)


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

  • Churchill Hospital
    Churchill Hospital Old Road Headington
    Oxford
    OX3 7LE
  • Nottingham University Hospitals NHS Trust - Queen's Medical Centre Campus
    Nottingham University Hospital Derby Road
    Nottingham
    NG7 2UH
  • Queen Elizabeth Hospital
    Woolwich Stadium Road Woolwich
    London
    SE18 4QH
  • Ninewells Hospital
    Ninewells Avenue
    Dundee
    DD1 9SY
  • St George's Hospital
    Blackshaw Road Tooting
    London
    SW17 0QT
  • Salford Royal
    Stott Lane
    Salford
    M6 8HD
  • Kings College Hospital
    Denmark Hill
    London
    SE5 9RS
  • Russells Hall Hospital
    Pensnett Road
    Dudley
    DY1 2HQ
  • Homerton University Hospital
    Homerton Row
    London
    E9 6SR
  • Royal Devon and Exeter Hospital
    Royal Devon & Exeter Hospital Barrack Road
    Exeter
    EX2 5DW
  • Guys and St Thomas Hospital
    Great Maze Pond
    London
    SE1 9RT
  • Royal Victoria Infirmary
    Claremont Wing Eye Dept Royal Victoria Infirmary Queen Victoria Road
    Newcastle upon Tyne
    NE1 4LP

The therapies involved in BEACON are all used in standard NHS practice. These include the very latest eczema treatments which are not available through the NHS if participants have not already tried standard treatments. There is therefore a good possibility that participants will see benefits to their health including a reduction in eczema symptoms and signs. Participants will be monitored very closely by the clinical study team and will have access to a dedicated study team. Close monitoring and contact will allow the team to answer any questions or concerns relating to care and wellbeing throughout the study. It is hoped that the information from this study will help to provide more effective and better-tolerated treatment for people with eczema in the future.
Participants will be required to attend the clinic seven times throughout the study and up to six additional safety blood tests/blood pressure measurements that mirror current standard clinical care. The local study team will try to streamline each clinic visit as much as possible to reduce the time burden and community safety assessments will be utilised where possible. Blood tests may be uncomfortable and cause some bruising or lightheadedness. On very rare occasions infection can arise as a result of having blood taken. To reduce discomfort all required samples at any one visit will be taken at the same time by a clinical professional trained and experienced in taking blood from patients.
Participants are required to complete multiple questionnaires before each visit which adds additional time burden, however, questionnaires will be sent out in advance so they can be completed remotely at a convenient time for the participant.
The "wash out" of any current phototherapy or systemic treatment prior to the start of the trial presents a risk of exacerbating current eczema symptoms, however during this period participants will be closely monitored and assessed to ensure their skin does not significantly deteriorate and that it is still safe for them to take part in the trial. The study design allows for moisturisers, topical steroids and topical calcineurin inhibitors to be used by participants throughout the screening period and the study in order to prevent disease flare-ups.
Whilst all of the trial interventions are widely used in eczema and have established safety profiles, there are risks of side effects occurring with each treatment, as well as the risk of eczema symptoms worsening; the potential risks and benefits of each study medication are detailed in the drug-specific information leaflets (British Association of Dermatology information leaflets for the specific drugs, used in routine practice) attached to the Patient Information Leaflet and will be discussed with the investigator prior to informed consent being provided. Upon randomisation, and knowing which drug a participant will be taking, the investigators will be encouraged to re-summarise the key relevant side effects associated with that specific medicine. The participant will be provided with the local study team details so any concerning symptoms can be reported and escalated if necessary. Any adverse events experienced throughout the trial will be evaluated by the site investigator for intensity (mild, moderate or severe); causality (not related, unlikely, possible, likely, or definitely related to the trial intervention); and expectedness (unexpected or expected, based on the Summary of Product Characteristics and Reference Safety Information for that medication). The site investigator will assess whether an AE is severe enough to require the participant to withdraw from the study treatment and the participant bears the right to withdraw at any time if an AE is intolerable.
Dupilumab is commonly associated with cases of conjunctivitis and allergic conjunctivitis, eye pruritus, blepharitis, and dry eye and with infrequent cases of keratitis and ulcerative keratitis. In line with the MHRA drug safety update (November 2022), clinicians are advised to be alert to the risks of ocular reactions and promptly review new onset or worsening ocular symptoms, referring patients for an eye examination as appropriate. Conjunctivitis or dry eye that does not resolve following initial treatment, or patients with signs and symptoms suggestive of keratitis (especially eye pain and vision changes) will also be referred for an eye examination, as appropriate. Sudden changes in vision and significant eye pain will warrant urgent ophthalmology review. Clinicians will also discuss with patients or caregivers the potential for, and symptoms of these ocular side effects and advise them to promptly report new-onset or worsening eye symptoms to their healthcare professional so that appropriate treatment can be initiated.
Abrocitinib should only be used if no suitable treatment alternatives are available in patients who are 65 years of age and older, who have a history of atherosclerotic cardiovascular disease or other cardiovascular risk factors (such as current or past long-time smokers), and who have malignancy risk factors (e.g. current malignancy or history of malignancy). Note, the need for a shingles vaccination (Shingrix) should be considered based on any specific risk factors relevant to the individual participant and up-to-date formal Green Book guidance: Immunisation against infectious disease - GOV.UK (https://www.gov.uk).
Methotrexate, dupilumab, and abrocitinib may be harmful to a baby in the womb (limited data for dupilumab, no evidence of harm). Women of childbearing potential are advised to use effective contraception during the trial. Men are advised to use effective contraception if taking methotrexate. Both women and men are advised not to conceive for 6 months post-cessation of methotrexate, and women for 1-month post-cessation of abrocitinib. Urine pregnancy tests will be performed.
Participants will need to avoid live or live-attenuated vaccines whilst on study treatments and for up to 3-12 months after the end of treatment. This is discussed in the Participant Information Leaflet and participants are advised to liaise with their study team if they have been invited to receive or require any vaccines.

Dr Andrew Pink
+44 (0)207 188 7188 ext 5156
BEACON@kcl.ac.uk



More information about this study, what is involved and how to take part can be found on the study website.


The study is sponsored by Guy's and St Thomas' NHS Foundation Trust; King's College London and funded by Health Technology Assessment Programme; Medac; Pfizer.



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Read full details for Trial ID: ISRCTN11056540

Or CPMS 53153

Last updated 06 March 2025

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