Best Systemic Treatments for Adults with Atopic Eczema over the Long Term (BEACON): a Phase IV, multi-arm multi-stage, assessor-blind randomised control trial comparing the effectiveness, tolerability and cost-effectiveness of systemic treatments for adults with moderate-severe atopic eczema
Atopic dermatitis
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. Ciclosporin: 3 mg/kg orally daily increasing to 5 mg/kg daily after 3 months if required (joint patient/investigator decision as per standard practice). Dose reduction is permitted at any point and will be documented in the participants’ medical notes/source data worksheets and CRF. 2. Methotrexate: Self-administered subcutaneous injection, 15 mg once weekly, increasing to 20 mg after 3 months if required (joint patient/investigator decision, as per standard practice). A dose reduction is permitted at any point and will be documented in the participants' medical notes/Source Data Worksheets and CRF. 3. Dupilumab: Self-administered subcutaneous injection, 600 mg (week 0) followed by 300 mg every 2 weeks (standard licensed dose, no adjustments). 4. Abrocitinib: 200 mg orally daily. Dose reduction is permitted at any point and will be documented in the participants’ medical notes/source data worksheets and CRF. All treatments will be taken by participants for a maximum of 12 months on the trial. Previous interventions: Randomization is being performed using the King's Clinical Trials Unit Randomization system online, specific to the requirements of the BEACON trial. 1. Ciclosporin: 3 mg/kg orally daily increasing to 5 mg/kg daily after 3 months if required (joint patient/investigator decision as per standard practice). Dose reduction is permitted at any point and will be documented in the participants’ medical notes/source data worksheets and CRF. 2. Methotrexate: Self-administered subcutaneous injection, 15 mg once weekly, increasing to 20 mg after 3 months if required (joint patient/investigator decision, as per standard practice). A dose reduction is permitted at any point and will be documented in the participants' medical notes/Source Data Worksheets and CRF. 3. Dupilum
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
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