Back to resultsRole of Anti-IgE in Severe Childhood Eczema (ADAPT)
Primary Purpose
Atopic Eczema, Atopic Dermatitis, Child
Status
Completed
Phase
Phase 4
Locations
United Kingdom
Study Type
Interventional
Intervention
Xolair
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Atopic Eczema
Eligibility Criteria
Inclusion Criteria:
- Children between the ages of 4-19 years
- Severe eczema
- Raised SpIgE or SPT to at least 1 food allergen or 1 aeroallergen AND/OR
- Clinical impression that allergic exposures cause worsening eczema.
- Total IgE level >300 kU/l
- Clinically proven IgE-mediated allergic disease.
- Written informed consent to participate.
Exclusion criteria:
- Inability to comply with 2-4 weekly injections and clinic visits
- Evidence of underlying immune compromise, autoimmune disease, immune complex mediated conditions.
- Uncontrolled infection or unstable eczema.
- Malignancy or a history of malignancy.
- Pre-existing hepatic or renal impairment
- Known cardiovascular or ischaemic cerebrovascular abnormality.
- Other serious or uncontrolled systemic disease.
- Pregnancy or lactation.
- Known history of hypersensitivity or anaphylaxis to anti-IgE injections or its constituents.
- Insufficient understanding of the trial assessments.
- Participation in a CTIMP in the previous 60 days or (if known) 4 half-lives of the relevant medication, whichever is the greater.
- Investigator feels that there is a good clinical reason why the child would be unsuitable.
Sites / Locations
- Guy's and St Thomas' NHS Foundation Trust
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Xolair/Omalizumab
Placebo
Arm Description
Outcomes
Primary Outcome Measures
Improvement in atopic eczema
Secondary Outcome Measures
Full Information
NCT ID
NCT02300701
First Posted
November 21, 2014
Last Updated
August 8, 2019
Sponsor
Guy's and St Thomas' NHS Foundation Trust
Collaborators
King's College London, National Institute for Health Research, United Kingdom
1. Study Identification
Unique Protocol Identification Number
NCT02300701
Brief Title
Role of Anti-IgE in Severe Childhood Eczema
Acronym
ADAPT
Official Title
The Role of Anti-IgE (Omalizumab) in the Management of Severe Recalcitrant Paediatric Atopic Eczema
Study Type
Interventional
2. Study Status
Record Verification Date
August 2019
Overall Recruitment Status
Completed
Study Start Date
December 2014 (undefined)
Primary Completion Date
August 2018 (Actual)
Study Completion Date
August 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Guy's and St Thomas' NHS Foundation Trust
Collaborators
King's College London, National Institute for Health Research, United Kingdom
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atopic Eczema, Atopic Dermatitis, Child
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
62 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Xolair/Omalizumab
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Xolair
Other Intervention Name(s)
Omalizumab
Intervention Description
According to manufacturer's instructions
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo
Primary Outcome Measure Information:
Title
Improvement in atopic eczema
Time Frame
24 weeks after treatment commences
10. Eligibility
Sex
All
Minimum Age & Unit of Time
4 Years
Maximum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Children between the ages of 4-19 years
Severe eczema
Raised SpIgE or SPT to at least 1 food allergen or 1 aeroallergen AND/OR
Clinical impression that allergic exposures cause worsening eczema.
Total IgE level >300 kU/l
Clinically proven IgE-mediated allergic disease.
Written informed consent to participate.
Exclusion criteria:
Inability to comply with 2-4 weekly injections and clinic visits
Evidence of underlying immune compromise, autoimmune disease, immune complex mediated conditions.
Uncontrolled infection or unstable eczema.
Malignancy or a history of malignancy.
Pre-existing hepatic or renal impairment
Known cardiovascular or ischaemic cerebrovascular abnormality.
Other serious or uncontrolled systemic disease.
Pregnancy or lactation.
Known history of hypersensitivity or anaphylaxis to anti-IgE injections or its constituents.
Insufficient understanding of the trial assessments.
Participation in a CTIMP in the previous 60 days or (if known) 4 half-lives of the relevant medication, whichever is the greater.
Investigator feels that there is a good clinical reason why the child would be unsuitable.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
S Chan, MBBS, MD
Organizational Affiliation
Guy's and St Thomas' Hospitals NHS Foundation Trust
Official's Role
Principal Investigator
Facility Information:
Facility Name
Guy's and St Thomas' NHS Foundation Trust
City
London
ZIP/Postal Code
SE1 7EH
Country
United Kingdom
12. IPD Sharing Statement
Citations:
PubMed Identifier
31764962
Citation
Chan S, Cornelius V, Cro S, Harper JI, Lack G. Treatment Effect of Omalizumab on Severe Pediatric Atopic Dermatitis: The ADAPT Randomized Clinical Trial. JAMA Pediatr. 2020 Jan 1;174(1):29-37. doi: 10.1001/jamapediatrics.2019.4476.
Results Reference
derived
PubMed Identifier
28330497
Citation
Chan S, Cornelius V, Chen T, Radulovic S, Wan M, Jahan R, Lack G. Atopic Dermatitis Anti-IgE Paediatric Trial (ADAPT): the role of anti-IgE in severe paediatric eczema: study protocol for a randomised controlled trial. Trials. 2017 Mar 22;18(1):136. doi: 10.1186/s13063-017-1809-7.
Results Reference
derived
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Role of Anti-IgE in Severe Childhood Eczema
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