Status:
COMPLETED
Role of Anti-IgE in Severe Childhood Eczema
Lead Sponsor:
Guy's and St Thomas' NHS Foundation Trust
Collaborating Sponsors:
King's College London
National Institute for Health Research, United Kingdom
Conditions:
Atopic Eczema
Atopic Dermatitis
Eligibility:
All Genders
4-19 years
Phase:
PHASE4
Brief Summary
To evaluate the efficacy of anti-IgE (Omalizumab/Xolair) in children with severe eczema.
Detailed Description
To address the value of anti-IgE in children with severe eczema.
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- Children between the ages of 4-19 years
- Severe eczema
- Raised SpIgE or SPT to at least 1 food allergen or 1 aeroallergen AND/OR
- Clinical impression that allergic exposures cause worsening eczema.
- Total IgE level \>300 kU/l
- Clinically proven IgE-mediated allergic disease.
- Written informed consent to participate.
- Exclusion criteria:
- Inability to comply with 2-4 weekly injections and clinic visits
- Evidence of underlying immune compromise, autoimmune disease, immune complex mediated conditions.
- Uncontrolled infection or unstable eczema.
- Malignancy or a history of malignancy.
- Pre-existing hepatic or renal impairment
- Known cardiovascular or ischaemic cerebrovascular abnormality.
- Other serious or uncontrolled systemic disease.
- Pregnancy or lactation.
- Known history of hypersensitivity or anaphylaxis to anti-IgE injections or its constituents.
- Insufficient understanding of the trial assessments.
- Participation in a CTIMP in the previous 60 days or (if known) 4 half-lives of the relevant medication, whichever is the greater.
- Investigator feels that there is a good clinical reason why the child would be unsuitable.
Exclusion
Key Trial Info
Start Date :
December 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2018
Estimated Enrollment :
62 Patients enrolled
Trial Details
Trial ID
NCT02300701
Start Date
December 1 2014
End Date
August 1 2018
Last Update
August 9 2019
Active Locations (1)
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1
Guy's and St Thomas' NHS Foundation Trust
London, United Kingdom, SE1 7EH