Atopic dermatitis anti-IgE paediatric trial

Not Applicable

Completed

• Conditions: Topic: Children; Subtopic: Allergy, Infect &Immun; Disease: All Diseases; Subtopic: Dermatology; Disease: Dermatology; Topic: Dermatology; Infections and Infestations

• Registration Number: ISRCTN15090567
• Lead Sponsor: Guy's & St Thomas' NHS Foundation Trust & King's College London (Comprehensive)

Brief Summary

2017 protocol in: https://www.ncbi.nlm.nih.gov/pubmed/28330497 2017 statistical analysis plan in: https://www.ncbi.nlm.nih.gov/pubmed/28535776 2020 results in https://pubmed.ncbi.nlm.nih.gov/31764962/ (added 07/08/2020)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-12-03
• Study Completion: 2016-07-01
• Last Update Posted: 9 November 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 62

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.

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Eczema severity; Timepoint(s): End of treatment