NCT02300701CompletedPhase 4
The Role of Anti-IgE (Omalizumab) in the Management of Severe Recalcitrant Paediatric Atopic Eczema
Guy's and St Thomas' NHS Foundation Trust1 site in 1 country62 target enrollmentStarted: December 2014Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Enrollment
- 62
- Locations
- 1
- Primary Endpoint
- Improvement in atopic eczema
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 4 Years to 19 Years (Child, Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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 Criteria
- Not provided
Arms & Interventions
Xolair/Omalizumab
Experimental
Intervention: Xolair (Drug)
Placebo
Placebo Comparator
Intervention: Placebo (Drug)
Outcomes
Primary Outcomes
Improvement in atopic eczema
Time Frame: 24 weeks after treatment commences
Secondary Outcomes
No secondary outcomes reported
Investigators
Study Sites (1)
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