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ADAPT: Role of Anti-IgE in Severe Childhood Eczema

Sponsor
Guy's and St Thomas' NHS Foundation Trust (Other)
Overall Status
Completed
CT.gov ID
NCT02300701
Collaborator
King's College London (Other), National Institute for Health Research, United Kingdom (Other)
62
Enrollment
1
Location
2
Arms
44
Duration (Months)
1.4
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
Phase 4

Detailed Description

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

Study Design

Study Type:
Interventional
Actual Enrollment :
62 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
The Role of Anti-IgE (Omalizumab) in the Management of Severe Recalcitrant Paediatric Atopic Eczema
Study Start Date :
Dec 1, 2014
Actual Primary Completion Date :
Aug 1, 2018
Actual Study Completion Date :
Aug 1, 2018

Arms and Interventions

Arm Intervention/Treatment
Experimental: Xolair/Omalizumab

Drug: Xolair
According to manufacturer's instructions
Other Names:
  • Omalizumab

    		•
    Placebo Comparator: Placebo

    Drug: Placebo
    Placebo

    Outcome Measures

    Primary Outcome Measures

    1. Improvement in atopic eczema [24 weeks after treatment commences]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    4 Years to 19 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Guy's and St Thomas' NHS Foundation Trust London United Kingdom SE1 7EH

    Sponsors and Collaborators

    • Guy's and St Thomas' NHS Foundation Trust
    • King's College London
    • National Institute for Health Research, United Kingdom

    Investigators

    • Principal Investigator: S Chan, MBBS, MD, Guy's and St Thomas' Hospitals NHS Foundation Trust

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Guy's and St Thomas' NHS Foundation Trust
    ClinicalTrials.gov Identifier:
    NCT02300701
    Other Study ID Numbers:
    • ADAPT
    First Posted:
    Nov 25, 2014
    Last Update Posted:
    Aug 9, 2019
    Last Verified:
    Aug 1, 2019
    Additional relevant MeSH terms:
    Dermatitis, Atopic
    Dermatitis
    Eczema
    Omalizumab

    Study Results

    No Results Posted as of Aug 9, 2019