Atopic dermatitis Skin and Connective Tissue Diseases Atopic dermatitis
Conditions
Interventions
Current interventions as of 06/03/2025:
Randomization is being performed using the King's Clinical Trials Unit Randomization system online, specific to the requirements of the BEACON trial.
1. Ciclos
Sponsors
Guy's and St Thomas' NHS Foundation Trust
King's College London
Eligibility
Sex/Gender
All
Age
18 Years to 120 Years
Inclusion criteria
Inclusion criteria: 1. Patients must be deemed to have the capacity to provide verbal fully informed consent to participate 2. Adults (aged 18+ years) with a diagnosis of atopic eczema (UK Working Party Diagnostic Criteria) 3. Moderate to severe eczema requiring systemic therapy 4. Objective measure of moderate to severe eczema based on an Investigator Global Assessment (vIGA-AD) score of =3 at baseline 5. Willing and able to comply with scheduled visits, treatment plan, laboratory tests and other study procedures
Exclusion criteria
Exclusion criteria: 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). 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 investigator 2. 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) Abrocitinib 1. 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 older 2. 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 int
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective disease severity measured using the Eczema Area Severity Index (EASI, blinded assessment) at baseline and 6 months post-randomisation | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Eczema severity measured by: 1.1. EASI (blinded assessment): 1.1.1. EASI50/EASI75/EASI90/EASI100/absolute EASI =7 (months 1, 3, 6, 9, 12, presented as proportion achieving these outcomes) 1.1.2. Change from baseline in EASI (months 1, 3, 9, 12, presented as mean absolute change) 1.2. Investigator Global Assessment (vIGA-AD, blinded assessment, months 1, 3, 6, 9, 12, proportion clear/almost clear) 2. Patient-reported symptoms (months 1, 3, 6, 9, 12) measured by: 2.1. Patient Orientated Eczema Measure (POEM, mean absolute change from baseline) 2.2. 11-point peak pruritus numerical rating scale (NRS, mean absolute change from baseline) 2.3. Overall disease control (RECAP, mean absolute change from baseline) 2.4. Patient global assessment (PtGA (5-point scale), proportion clear/almost clear) 3. Quality of life measured by Dermatology Life Quality Index (DLQI) at months 1, 3, 6, 9, 12, mean absolute change from baseline and proportion achieving DLQI =5 4. Depression and anxiety measured by Patient Health Questionnaire 9-item and Generalised Anxiety Disorder 7-item (PHQ-9 and GAD-7) at months 6, 12, mean absolute change from baseline and proportion with score <5) 5. Health economic outcomes (months 3, 6, 9, 12): 5.1. Resource use questionnaire 5.2. 5-level EQ-5D (EQ-5D-5L, months 3, 6, 9, 12 mean utility by study arm at each time point. Used to estimate QALYs as described in the HEAP. 6. Safety outcomes will include (continuous to 12 months): 6.1. Adverse events 6.2. Adverse events of special interest 7. Adherence and tolerability: 7.1. Visual Analog Scale (VAS) for Medications Taken at months 1, 3, 6, 9, 12 7.2. Tolerability measured using a non-validated measure (Likert scale) at months 1, 3, 6, 9, 12 | — |
Countries
England, Scotland, United Kingdom, Wales
Outcome results
None listed