Role of Anti-IgE in Severe Childhood Eczema (ADAPT)

Guy's and St Thomas' NHS Foundation Trust

Status and phase: Completed; Phase 4

Conditions: Atopic Dermatitis; Child; Atopic Eczema

Treatments: Drug: Placebo; Drug: Xolair

Study type: Interventional

Funder types: Other

Identifiers

NCT02300701

ADAPT

Details and patient eligibility

About

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

Full description

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

Enrollment: 62 patients

Sex: All

Ages: 4 to 19 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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62 participants in 2 patient groups, including a placebo group

Xolair/Omalizumab

Experimental group

Treatment:

Drug: Xolair

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo