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

August 8, 2019 updated by: Guy's and St Thomas' NHS Foundation Trust

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Actual)

62

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • London, United Kingdom, SE1 7EH
        • Guy's and St Thomas' NHS Foundation Trust

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

4 years to 19 years (ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
PLACEBO_COMPARATOR: Placebo
Drug: Placebo
Placebo
EXPERIMENTAL: Xolair/Omalizumab
Drug: Xolair
According to manufacturer's instructions
Other Names:
  • Omalizumab

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Improvement in atopic eczema
Time Frame: 24 weeks after treatment commences
24 weeks after treatment commences

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Guy's and St Thomas' NHS Foundation Trust

Collaborators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2014

Primary Completion (ACTUAL)

August 1, 2018

Study Completion (ACTUAL)

August 1, 2018

Study Registration Dates

First Submitted

November 21, 2014

First Submitted That Met QC Criteria

November 24, 2014

First Posted (ESTIMATE)

November 25, 2014

Study Record Updates

Last Update Posted (ACTUAL)

August 9, 2019

Last Update Submitted That Met QC Criteria

August 8, 2019

Last Verified

August 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ADAPT

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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