Role of Anti-IgE in Severe Childhood Eczema

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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02300701

Acronym

ADAPT

Enrollment

Registered

2014-11-25

Start date

2014-12-31

Completion date

2018-08-31

Last updated

2019-08-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atopic Eczema, Atopic Dermatitis, Child

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.

Interventions

DRUGXolair

According to manufacturer's instructions

DRUGPlacebo

Placebo

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

4 Years to 19 Years

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.

Design outcomes

Primary

Measure	Time frame
Improvement in atopic eczema	24 weeks after treatment commences

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 27, 2026