The TREatment of Severe Atopic Ezcema Trial: TREAT

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: 102

Inclusion Criteria

1.Written informed consent for study participation obtained from the patient or parents / legal guardian, with assent as appropriate by the patient, depending on the level of understanding.
2.Aged 2-16 years at the time of the screening and randomisation visit
3.Diagnosis of severe recalcitrant atopic eczema
4.History of inadequate clinical response (in the opinion of the treating clinician) to potent topical corticosteroids on the body and moderate strength topical corticosteroids on the face.
5.An objective (o)-SCORAD severity score of at least 30
6.Participants must live within travelling distance of the recruiting centre
7.Females of childbearing potential and males, who are sexually active, must commit to consistent and correct use of an highly effective method of contraception (e.g. combined hormonal contraception, intrauterine device, physical barrier or abstinence) for the duration of the trial and for 6 months after the last dose of study drug.
a.Females of childbearing potential for this study are: Females, regardless of their age, with functioning ovaries and no documented impairment of oviductal or uterine function that would cause sterility. This category includes young females who have begun to menstruate, or females with oligomenorrhea.
8.Willingness to comply with study requirements
9.Baseline visit within 2 weeks of the screening visit

Are the trial subjects under 18? yes
Number of subjects for this age range: 102
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. Serious underlying medical condition which in the opinion of the Investigator
would compromise the safety of the patient.
2. Pregnant or nursing (lactating) females, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hCG laboratory test.
3. Any active and/or chronic infection at screening or baseline (randomisation) visit that, based on the investigator's clinical assessment, makes the subject an
unsuitable candidate for the study.
4. Presence of moderate to severe impaired renal function as indicated by clinically significantly abnormal creatinine (= 1.5 x upper normal limit (ULN) for age and
sex) AND eGFR <60ml/min/1.73m2 at screening visit.*
5. Clinical evidence of liver disease or liver injury at screening visit as indicated by
abnormal liver function tests such as AST, ALT, GGT, alkaline phosphatase, or
serum bilirubin (must not exceed 1.5 x the upper limit value of the normal range
for age and sex).
6. Total WBC count <3x109/L, or platelets <150x109/L or neutrophils <1.5x109/L or haemoglobin <8.5 g/L at screening visit.
7. Blood pressure values > 95th percentile for age and sex at screening and baseline visit. **
8. Received systemic cortico-steroids within 14 days prior to screening visit and 28 days of baseline visit.
9. Received phototherapy within 4 weeks prior to screening visit and 6 weeks of the baseline visit.
10. Previous exposure to any biologic agents or systemic immuno-suppressive
therapy, except for oral corticosteroids (CS) for acute flare management.
11. Concomitant use of disease-modifying and/or immunosuppressive drugs.
12. Received live vaccines within 4 weeks prior to baseline visit.
13. Radiology report of abnormal chest x-ray at the screening visit (at the discretion of the PI/medically qualified physician - see section 7.1 for further details)
14. Receiving treatment with medicines that are substrates for the multidrug efflux transporter P-glycoprotein or the organic anion transporter proteins (OATP) for
which elevated plasma concentrations are associated with serious and/or lifethreatening events; this includes bosentan, dabigatran etexilate and aliskiren.
15. Receiving treatment with products containing Hypericum perforatum (St. John's wort)
16. Receiving oral treatment with tacrolimus
17. Receiving oral treatment with everolimus and sirolimus
18. Receiving oral treatment with lercanidipine
19. Currently participating in a conflicting study or participation in a clinical study
involving a medicinal product in the last 28 days or less than 5 half-lives of the
medicinal product prior to the screening visit.
20. Known hypersensitivity to methotrexate or ciclosporin products.
21. Insufficient understanding of the trial by the patient and/or parent/guardian.

*Please ensure the following formula is used for calculating eGFR: eGFR = height (cm) x40/plasma creatinine (micromol/l)

** If an accurate blood pressure reading is unobtainable (e.g. due the patient being distressed), the patient’s GP may be approached in order to obtain an accurate reading if a blood pressure measurement has been carried out within 4 weeks of the screening and baseline visit. A community nurse may also carry out a blood pressure measurement at the patient’s home to confirm eligibility and also during the follow up visits. Without an accurate blood pressure measurement below the 95th centile of systolic BP for age and sex, a patient cannot be randomised

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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