Role of Anti-IgE in Severe Childhood Eczema

Phase 4

Completed

• Conditions: Atopic Eczema; Atopic Dermatitis; Child
• Interventions: Drug: Xolair; Drug: Placebo

• Registration Number: NCT02300701
• Lead Sponsor: Guy's and St Thomas' NHS Foundation Trust

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 Timeline

• Study First Submitted: 2014-11-21
• Study First Submitted QC: 2014-11-24
• Study First Posted: 2014-11-25
• Study Start: 2014-12
• Primary Completion: 2018-08
• Study Completion: 2018-08
• Status Verified: 2019-08
• Last Update Submitted: 2019-08-08
• Last Update Posted: 2019-08-09

Recruitment & Eligibility

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

Inclusion Criteria

1. Children between the ages of 4-19 years
2. Severe eczema
3. Raised SpIgE or SPT 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.
7. Written informed consent to participate.

Exclusion criteria:

1. Inability to comply with 2-4 weekly injections and clinic visits
2. Evidence of underlying immune compromise, autoimmune disease, immune complex mediated conditions.
3. Uncontrolled infection or unstable eczema.
4. Malignancy or a history of malignancy.
5. Pre-existing hepatic or renal impairment
6. Known cardiovascular or ischaemic cerebrovascular abnormality.
7. Other serious or uncontrolled systemic disease.
8. Pregnancy or lactation.
9. Known history of hypersensitivity or anaphylaxis to anti-IgE injections or its constituents.
10. Insufficient understanding of the trial assessments.
11. Participation in a CTIMP in the previous 60 days or (if known) 4 half-lives of the relevant medication, whichever is the greater.
12. Investigator feels that there is a good clinical reason why the child would be unsuitable.

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Xolair/Omalizumab	Xolair	-
Placebo	Placebo	-

Primary Outcome Measures

Name	Time	Method
Improvement in atopic eczema	24 weeks after treatment commences

Trial Locations

Locations (1)

Guy's and St Thomas' NHS Foundation Trust; 🇬🇧 London, United Kingdom