Plain English Summary
Background and study aims
Up to 1 child in 5 has eczema. Many of these children are successfully treated by creams or medicines. However, a small number of these children have such severe eczema that the available medicines are unable to control it. Other children have side effects from the medication, so that they cannot continue to take it. The aim of this study is to see if a new medication, Xolair (also known as omalizumab or anti-IgE), can help children with severe eczema, who have not responded to other available treatments.
Who can participate?
Children aged 4-19 with severe eczema that is not controlled by available medications.
What does the study involve
Participants are randomly allocated into one of two groups. Those in group 1 receive Xolair for 6 months. Those in group 2 are given a placebo for 6 months. All participants are then monitored for a further 6 months after treatment.
What are the possible benefits and risks of participating?
Ultimately it is hoped that the treatments in this study will help children with eczema. However, there is no guarantee that a child’s eczema will get better if they participate in the study. The information we get from this study may, however, help to find better treatments for children with severe eczema with fewer side effects. Participants have to make a number of visits to hospital for the treatment. They also undergo allergy tests and other tests.
Where is the study run from?
Evelina Children’s Hospital, St Thomas’ Hospital, London (UK)
When is the study starting and how long is it expected to run for?
November 2014 to July 2016
Who is funding the study?
National Institute for Health Research (UK)
Who is the main contact?
Dr Susan Chan
Trial website
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
17968
Study information
Scientific title
The role of anti-IgE (omalizumab) in the management of severe recalcitrant paediatric atopic eczema
Acronym
ADAPT
Study hypothesis
This research aims to establish the role of anti-IgE therapy in children with severe eczema
Ethics approval
NRES Committee London - Westminster, 07/07/2011, ref. 11/LO/0123
Study design
Randomised interventional study
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Community
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details to request a patient information sheet
Condition
Topic: Children; Subtopic: Allergy, Infect &Immun; Disease: All Diseases; Topic: Dermatology; Subtopic: Dermatology; Disease: Dermatology
Intervention
Patients will receive anti-IgE/Xolair/omalizumab or placebo for 24 weeks, and will be followed up for a further 24 weeks. Dosage and frequency of treatment will be determined by the standard manufacturer’s dosing tables, and will be administered by subcutaneous injection.
Intervention type
Drug
Phase
Not Applicable
Drug names
Omalizumab
Primary outcome measure
Eczema severity; Timepoint(s): End of treatment
Secondary outcome measures
N/A
Overall trial start date
20/11/2014
Overall trial end date
01/07/2016
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Children between the ages of 4-19 years at the time of enrolment into the trial
2. Severe eczema with
2.1. an objective SCORAD (a validated eczema severity score) of over 40
2.2. in a patient unresponsive to optimal topical therapy (potent topical steroids and topical calcineurin inhibitors)
2.3. in whom there is no impression of lack of compliance
2.4. with a (C)DLQI score of ≥10
2.5. and in whom active infection has been ruled out and/or adequately treated
3. Raised SpIgE (>0.35 IU/ml)or SPT (>3mm)to at least 1 food allergen or 1 aeroallergen
AND/OR
4. Clinical impression that allergic exposures cause worsening eczema.
5. Total IgE level >300 kU/l.
6. Clinically proven IgE-mediated allergic disease including at least 1 of the following:
6.1. Immediate hypersensitivity to a food as proven by raised specific IgE (SpIgE) or skin prick test (SPT) greater than the 95% positive predictive value or ≥8mm, or a positive double blind placebo controlled food challenge,
6.2. Allergic rhinoconjunctivitis as defined by sensitisation to a respiratory allergen and clinical history of rhinoconjunctivitis symptoms when exposed to the relevant allergen
6.3. Allergic asthma: a history of cough, wheeze, or shortness of breath that
6.3.1. Was responsive to therapy with bronchodilators on two or more occasions in the previous 24 months
6.3.2. Required one visit to a physician in the previous 24 months
6.3.3. Occurred during the night, during early morning, or upon exercising in the intervals between exacerbations at any time in the previous 12 months
6.3.4. Where allergic exacerbations can be clinically related to an allergen exposure WITH a corresponding positive SPT or SpIgE to allergen
7. Written informed consent to participate.
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
Planned Sample Size: 62; UK Sample Size: 62
Participant exclusion criteria
1. Children and/or families who are unable to comply with the regime of 24 weekly injections and clinic visits
2. Evidence of underlying immune compromise, autioimmune disease, immune complex mediated conditions
3. Malignancy or a history of malignancy
4. Preexisting hepatic or renal impairment
5. Known cardiovascular or ischaemic cerebrovascular abnormality
6. Other serious or uncontrolled systemic disease
7. Pregnancy or lactation
8. Known history of hypersensitivity or anaphylaxis to anti-IgE injections or its constituents
9. Insufficient understanding of the trial assessments
10. Participation in a CTIMP in the previous 60 days or (if known) 4 half-lives of the relevant medication, whichever is the greater. In this case, entry may be delayed until the appropriate time
11. Investigator feels that there is a good clinical reason why the child would be unsuitable to participate in the study
Recruitment start date
20/11/2014
Recruitment end date
01/01/2016
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Guy's and St. Thomas' NHS Foundation Trust
St Thomas's Hospital
249 Westminster Bridge Road
London
SE1 7EH
United Kingdom
Funders
Funder type
Government
Funder name
National Institute for Health Research
Alternative name(s)
NIHR
Funding Body Type
government organisation
Funding Body Subtype
Federal/National Government
Location
United Kingdom
Results and Publications
Publication and dissemination plan
To be confirmed at a later date
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
2017 protocol in: https://www.ncbi.nlm.nih.gov/pubmed/28330497
2017 statistical analysis plan in: https://www.ncbi.nlm.nih.gov/pubmed/28535776