Condition category
Infections and Infestations
Date applied
03/12/2014
Date assigned
03/12/2014
Last edited
09/12/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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 purpose of the 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 we hope 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 may, however, help us to find better treatments for children with severe eczema, which have fewer side effects. Participants will have to make a number of visits to hospital for the treatment. They will also have allergy tests, and other tests performed.

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

Contact information

Type

Scientific

Primary contact

Dr Susan Chan

ORCID ID

Contact details

Guy's and St. Thomas' NHS Foundation trust
St Thomas's Hospital
249 Westminster Bridge Road
London
SE1 7EH
United Kingdom

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

Our 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

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 below 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 received 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

Primary outcome measures

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

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

Sponsor information

Organisation

Guy's & St. Thomas' NHS Foundation Trust & King's College London (Comprehensive)

Sponsor details

Imaging Sciences
The Rayne Institute
Lambeth Wing - 4th floor
St Thomas' Hospital
London
SE1 7EH
United Kingdom

Sponsor type

Hospital/treatment centre

Website

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes