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NCT02300701 Clinical Trial

Role of Anti-IgE in Severe Childhood Eczema

Atopic Dermatitis Clinical Trial

— ADAPT  

Official title:
The Role of Anti-IgE (Omalizumab) in the Management of Severe Recalcitrant Paediatric Atopic Eczema

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02300701
Other study ID # ADAPT
Secondary ID
Status Completed
Phase Phase 4
First received
Last updated
Start date December 2014
Est. completion date August 2018

Study information
Verified date August 2019
Source Guy's and St Thomas' NHS Foundation Trust
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

Description:

To address the value of anti-IgE in children with severe eczema.

Recruitment information / eligibility
Status Completed
Enrollment 62
Est. completion date August 2018
Est. primary completion date August 2018
Accepts healthy volunteers No
Gender All
Age group 4 Years to 19 Years
Eligibility 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.

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Xolair
According to manufacturer's instructions
• Placebo
Placebo

Locations
Country Name City State
United Kingdom Guy's and St Thomas' NHS Foundation Trust London

Sponsors (3)
Lead Sponsor Collaborator
Guy's and St Thomas' NHS Foundation Trust King's College London, National Institute for Health Research, United Kingdom

Country where clinical trial is conducted

United Kingdom, 

Outcome
Type Measure Description Time frame Safety issue
Primary Improvement in atopic eczema 24 weeks after treatment commences
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