Atopic Dermatitis Anti-IgE Paediatric Trial (ADAPT): the role of anti-IgE in severe paediatric eczema: study protocol for a randomised controlled trial.
The evidence for systemic treatments for severe childhood eczema is limited and largely based on extrapolation of data from adult studies. Current therapies are often immunosuppressant and may be associated with both short- and long-term side effects. There is increasing in vitro and murine-model evidence for the role of IgE in the immunopathogenesis of atopic eczema. The aim of the study is to assess whether anti-IgE treatment (omalizumab) improves eczema, compared to placebo.



The Atopic Dermatitis Anti-IgE Paediatric Trial (ADAPT) is a randomised, double-blind, placebo-controlled study assessing the role of anti-IgE in the management of severe paediatric eczema. Children with severe atopic eczema, with an objective SCORing Atopic Dermatitis (SCORAD) score of over 40 will be recruited. These children are candidates for systemic therapy, have failed systemic therapy or have experienced side effects from systemic therapy. Sixty-two patients aged between 4 and 19 years will receive anti-IgE for 6 months. The primary outcome measure will be the validated eczema score, the objective SCORAD at 24 weeks. This study has 90% power to detect a 33% relative reduction in SCORAD between active and placebo groups, with 5% significance.



IgE may have a role to play in eczema, particularly in childhood. This forms the basis for the hypothesis that anti-IgE may be an effective treatment in this patient population. This will be the largest study to evaluate the efficacy of anti-IgE (omalizumab) versus placebo in children with severe eczema. The findings will help to clarify the role of anti-IgE as a potential treatment option in patients with severe childhood eczema.



European Clinical Trials Database (EudraCT) Number: 2010-020841-29 . Assigned on 14 May 2010. ISRCTN Registry, Identifier: ISRCTN15090567 . Retrospectively assigned on 3 December 2014. ClinicalTrials.gov, Identifier: NCT02300701 . First received 21 November 2014.
Guy's and St. Thomas' NHS Foundation Trust, Westminster Bridge Road, London, SE1 7EH, UK. susan.chan@kcl.ac.uk.|King's College London, King's Health Partners, Asthma-UK Centre in Allergic Mechanisms of Asthma, Department of Asthma, Allergy and Respiratory Science, Guy's Hospital, London, SE1 9RT, UK. susan.chan@kcl.ac.uk.
Susan
0000-0002-2174-0257
S
Chan
Imperial Clinical Trials Unit, School of Public Health, Imperial College London, Stadium House, 68 Wood Lane, London, W12 7RH, UK.
Victoria
V
Cornelius
Department of Clinical Sciences, Liverpool School of Tropical Medicine, Liverpool, L3 5QA, UK.
Tao
T
Chen
Guy's and St. Thomas' NHS Foundation Trust, Westminster Bridge Road, London, SE1 7EH, UK.|King's College London, King's Health Partners, Asthma-UK Centre in Allergic Mechanisms of Asthma, Department of Asthma, Allergy and Respiratory Science, Guy's Hospital, London, SE1 9RT, UK.
Suzana
S
Radulovic
Guy's and St. Thomas' NHS Foundation Trust, Westminster Bridge Road, London, SE1 7EH, UK.
Mandy
M
Wan
Guy's and St. Thomas' NHS Foundation Trust, Westminster Bridge Road, London, SE1 7EH, UK.
Rahi
R
Jahan
King's College London, King's Health Partners, Asthma-UK Centre in Allergic Mechanisms of Asthma, Department of Asthma, Allergy and Respiratory Science, Guy's Hospital, London, SE1 9RT, UK.
Gideon
G
Lack
D000293:Adolescent; D017668:Age of Onset; D002648:Child; D002675:Child, Preschool; D002985:Clinical Protocols; D003876:Dermatitis, Atopic / Q000175:diagnosis / Q000188:drug therapy* / Q000276:immunology; D003879:Dermatologic Agents / Q000009:adverse effects / Q000627:therapeutic use*; D004311:Double-Blind Method; D004485:Eczema / Q000175:diagnosis / Q000188:drug therapy* / Q000276:immunology; D005260:Female; D006801:Humans; D007073:Immunoglobulin E / Q000276:immunology*; D008131:London; D008297:Male; D000069444:Omalizumab / Q000009:adverse effects / Q000627:therapeutic use*; D012074:Remission Induction; D012107:Research Design; D012720:Severity of Illness Index; D013997:Time Factors; D016896:Treatment Outcome; D055815:Young Adult
D003879:Dermatologic Agents; D000069444:Omalizumab; D007073:Immunoglobulin E
Anti-IgE; Atopic dermatitis; Double blind; Eczema; Omalizumab; Paediatric; Placebo; Randomised controlled trial; Xolair®