Severe chronic atopic eczema MedDRA version: 12.1 Level: HLT Classification code 10012435 Term: Dermatitis and eczema MedDRA version: 12.1 Level: LLT Classification code 10001712 Term: Allergic eczema MedDRA version: 12.1 Level: LLT Classification code 10003641 Term: Atopic eczema MedDRA version: 12.1 Level: LLT Classification code 10012454 Term: Dermatitis eczematoid
Conditions
Interventions
Trade Name: Alutard SQ
Product Name: Dust mite subcutaneous immunotherapy with Alutard-SQ extract (ALK, Denmark)
Product Code: Alutard-SQ
Pharmaceutical Form: Solution for injection
Trade Name: flucl
Sponsors
Research and Development Department, John Radcliffe Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Participant is willing and able to give informed consent for participation in the study. • Male or Female, aged 16- 65 years or above. • Diagnosed with moderate-severe atopic eczema based on the UK modification of Hanifin and Rajka’s diagnostic criteria with a severe SCORAD index (>30) • Detectable circulating IgE specific for house dust mite • Able (in the Investigators opinion) and willing to comply with all study requirements. • Willing to allow his or her General Practitioner and consultant, if appropriate, to be notified of participation in the study. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: The participant may not enter the study if ANY of the following apply: • Female participant who is pregnant, lactating or planning pregnancy during the course of the study. • Severe asthma requiring regular inhalers • Concomitant unstable or serious systemic disease, including subjects known to be HIV positive • Previous malignant disease • Significant renal or hepatic impairment as defined by abnormal baseline bloods. • Scheduled elective surgery or other procedures requiring general anaesthesia during the study. • Participant who is terminally ill or is inappropriate for trial medication • Any other significant disease or disorder which, in the opinion of the Investigator, may either put the participants at risk because of participation in the study, or may influence the result of the study, or the participant’s ability to participate in the study. • Taking any essential medications which could not be taken in combinations with any of the proposed study medications. • Participants who have participated in another research study involving an investigational product in the past 12 weeks • Potential difficulty in attending for regular monitoring • Prominent infected eczema or eczema requiring systemic anti-bacterial treatment during the 2 weeks prior to trial entry. • Active use of systemic therapy • Known sensitivity to any of the active compounds (in particular known allergy to flucloxacillin/ penicillin) • HLA-B 5701 positive (associated with a rare side effect of flucloxacillin use) • Multiple IgE sensitisations beyond house dust mite.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To test whether combined antibiotics and allergen-immunotherapy (desensitisation to the allergen house dust mite) lead to clinical improvement in adults with severe atopic eczema. ;Secondary Objective: The secondary objectives are to investigate whether it is possible to identify allergen-specific T cell correlates of successful control of atopic dermatitis severity; and whether filaggrin genotypes influence clinical or T cell response to treatment.;Primary end point(s): Primary endpoint outcome measurement is clinical severity of eczema. This will be measured by two independant measurements of SCORAD score. (An approved and validated measure of eczema severity) The secondary outcome measurements will be allergen-specific T cell correlates of successful control of atopic dermatitis severity; and whether filaggrin genotypes influence clinical or T cell response to treatment. By identifying immune correlates of successful treatment we hope to further characterise the pathogenesis of atopic disease and to identify approaches to monitoring future efficacy trials. | — |
Countries
United Kingdom
Outcome results
None listed