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Clinical Trials/NCT02300701
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

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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