Role of Anti-IgE in Severe Childhood Eczema

• Status: Completed
• Trial end date: 2018-08-01
• Target enrollment: 0
• Participant gender: All

Summary

To evaluate the efficacy of anti-IgE (Omalizumab/Xolair) in children with severe eczema.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Guy's and St Thomas' NHS Foundation Trust
• Collaborators: King's College London; National Institute for Health Research, United Kingdom
• Treatments: Omalizumab

Criteria

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.