Atopic dermatitis anti-IgE paediatric trial
| ISRCTN | ISRCTN15090567 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN15090567 |
| ClinicalTrials.gov number | NCT02300701 |
| Secondary identifying numbers | 17968 |
- Submission date
- 03/12/2014
- Registration date
- 03/12/2014
- Last edited
- 26/10/2020
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Infections and Infestations
Plain English summary of protocol
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
Contact information
Scientific
Guy's and St. Thomas' NHS Foundation trust
St Thomas's Hospital
249 Westminster Bridge Road
London
SE1 7EH
United Kingdom
Study information
| Study design | Randomised interventional study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Community |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet |
| Scientific title | The role of anti-IgE (omalizumab) in the management of severe recalcitrant paediatric atopic eczema |
| Study acronym | ADAPT |
| Study objectives | This research aims to establish the role of anti-IgE therapy in children with severe eczema |
| Ethics approval(s) | NRES Committee London - Westminster, 07/07/2011, ref. 11/LO/0123 |
| Health condition(s) or problem(s) studied | 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Omalizumab |
| Primary outcome measure | Eczema severity; Timepoint(s): End of treatment |
| Secondary outcome measures | N/A |
| Overall study start date | 20/11/2014 |
| Completion date | 01/07/2016 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | Planned Sample Size: 62; UK Sample Size: 62 |
| Total final enrolment | 62 |
| Key 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. |
| Key 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 |
| Date of first enrolment | 20/11/2014 |
| Date of final enrolment | 01/01/2016 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
249 Westminster Bridge Road
London
SE1 7EH
United Kingdom
Sponsor information
Hospital/treatment centre
Imaging Sciences
The Rayne Institute
Lambeth Wing - 4th floor
St Thomas' Hospital
London
SE1 7EH
England
United Kingdom
"ROR" |
https://ror.org/00j161312 |
|---|
Funders
Funder type
Government
Government organisation / National government
- Alternative name(s)
- National Institute for Health Research, NIHR Research, NIHRresearch, NIHR - National Institute for Health Research, NIHR (The National Institute for Health and Care Research), NIHR
- Location
- United Kingdom
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | To be confirmed at a later date |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | protocol | 22/03/2017 | Yes | No | |
| Statistical Analysis Plan | statistical analysis plan | 23/05/2017 | No | No | |
| Results article | results | 25/11/2019 | 07/08/2020 | Yes | No |
| HRA research summary | 28/06/2023 | No | No |
Editorial Notes
26/10/2020: The NCT code has been added.
07/08/2020: The following changes were made to the trial record:
1. Publication reference added.
2. The total final enrolment was added.
30/05/2017: Publication reference added.
24/03/2017: Publication reference added.
